According to the nine-count complaint, all female plaintiffs were prescribed Zoloft while they were pregnant and all children from these pregnancies were born with major medical defects, including heart defects. The plaintiffs allege Pfizer was aware the drugs could cause serious problems to developing fetuses but covered up the evidence.

Zoloft is in a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. They are among the most prescribed drugs in the United States and include other brand name drugs such as Paxil, Celexa, Lexapro and Prozac. All SSRIs are currently categorized as Category C pregnancy drugs except Paxil, which was recently downgraded to a Category D drug based on studies that showed a definite link between its use during pregnancy and birth defects.

The complaint cites several studies that SSRIs double the risk of heart defects in children. Based on those studies, the plaintiffs claim that Pfizer must have known that the drugs were dangerous to use during pregnancy. They allege that the drug lacked proper warnings that would have given parents and their doctors ample opportunity to weigh the drug’s risks against its benefits.

The parents accuse Pfizer of negligence, fraud, misrepresentation and a breach of implied warranties. They also claim that the drug company violated Consumer Protection Laws. The plaintiffs are asking for actual and compensatory damages.

Source: Madison-St. Clair Record

SOURCE: Paxil and Pregnancy › Parents file birth defect lawsuit against Zoloft

The first study, published in July 2011, was conducted by Finnish researchers who found that exposure to SSRIs in the first trimester of pregnancy increases the risk for major congenital anomalies, particularly heart problems.

The second study, published earlier this month in the British Medical Journal, revealed that women who used SSRIs were at risk of delivering a baby with a serious and life threatening lung defect known as persistent pulmonary hypertension, or PPHN. This type of high blood pressure in the lungs leads to shortness of breath and other breathing difficulties. PPHN carries a strong link to heart failure.

The study showed that when women used SSRIs late in pregnancy, the risk of having a baby with PPHN increased two-fold compared to women who did not use SSRIs.

PPHN in babies is a very serious disease and one that can be prevented if these drugs are avoided. Yet, drug companies are quick to nay-say data from these studies that clearly show a risk to the developing fetus. Women who use SSRIs who are of childbearing age, or who are thinking of becoming pregnant, should discus the risks of taking SSRIs with their doctors.

SSRIs include the brand name drugs Paxil, Prozac, Zoloft and Celexa.

Source: Bio Hormone Health

SOURCE: Paxil and Pregnancy › Two studies show dangers of SSRI use during pregnancy

The study, conducted by researchers at Karolinska Institute in Stockholm, Sweden, found that infants born to women who took SSRIs late in their pregnancy had a two-fold increase of having PPHN compared to infants born to women who did not take the drugs.

The absolute risk was three infants per 1,000 exposed to SSRIs during late gestation. And the risk with different SSRIs was similar. Those involved in the study included sertraline, known by the brand Zoloft; citalopram, known by the brands Celexa and Ciprami; paroxetine, known by the brand Paxil, and fluoxetine, known by the brand Prozac.

Currently, only Paxil is listed as a Category D drug, meaning that it is discouraged during pregnancy because studies have linked use in pregnant women to birth defects. All other SSRIs are listed as Category C drugs, and are still considered relatively safe to use during pregnancy.

However, this latest study suggests that women and their doctors should use more caution when weighing risks and benefits of SSRIs during pregnancy, especially since most SSRIs are still considered safe to use during pregnancy despite the latest study suggesting otherwise.

SSRIs are among the most prescribed drugs in the United States. In the past two decades, use of antidepressants in the U.S. has increased 400 percent. Eleven percent of Americans over the age of 12 take an antidepressant, and about 14 percent of them have been using the medication for more than a decade.

Source: EMaxHealth

SOURCE: Paxil and Pregnancy › Another study shows PPHN risk with SSRI exposure

The survey, conducted by the Substance Abuse and Mental Health Services Administration, involved in-person interviews with 67,500 people aged 12 and older. Not only did the survey show that women were more likely to be depressed, the rate of mental illness among people aged 18 to 25 was twice that of those aged 50 and older.

The information goes hand-in-hand with other studies that show antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, are now one of the most prescribed medications in the United States. While many people find relief from their symptoms of depression and anxiety from these antidepressants, caution should be used by women, especially those of childbearing age and those who are pregnant or thinking of becoming pregnant. Studies have linked SSRI use during pregnancy to serious birth defects.

SSRIs include the brand names Paxil, Zoloft, Lexapro, Celexa and Prozac. All were considered relatively safe to use during pregnancy because there were no studies to prove that the drugs caused birth defects or other pregnancy complications. That is, until researchers began gathering data that showed a link between Paxil and persistent pulmonary hypertension (PPHN).

A stronger warning was placed on Paxil, but researchers are concerned that other drugs in the same class of antidepressants may carry the same risk for PPHN or other birth defects including heart defects, neural tube defects, and defects of the intestines or abdominal organs. Malformation defects have also been reported.

Source: Fox News

SOURCE: Paxil and Pregnancy › Women more likely than men to suffer from mental disorders

SSRIs are used to treat depression and some forms of anxiety. They are known by the brand names Zoloft, Paxil, Lexapro, Celexa and Prozac, and are among the most prescribed drugs in the country.

The FDA’s announcement is based on a large retrospective database study in 2009 that found no link between SSRI use and PPHN, and a case-control study of nearly 12,000 births that showed a link between PPHN and cesarean delivery, but not SSRI use in the second half of pregnancy. This conflicting data left the FDA panel members scratching their heads and siding with the drug companies, who profit heartily from antidepressant sales.

The FDA warns that untreated maternal depression can be risky and lead to low birth weight, preterm delivery, lower Apgar scores, poor prenatal care, failure to recognize or report impending labor, and increased risks of fetal abuse, neonaticide, or maternal suicide.

Yet, that risk should be weighed by the possible dangers SSRIs can cause babies. Despite the studies which indicate there might be a risk for PPHN if used during pregnancy, other studies show that the drugs could cause other serious defects such as malformations, heart defects and neural tube defects. Newer studies have suggested SSRI exposure in utero may also put babies at risk for autism.

At the very least, physicians and their patients should carefully weigh the risks and benefits of SSRIs before becoming pregnant.

Source: Clinical Psychiatry News

SOURCE: Paxil and Pregnancy › FDA gives go-ahead to prescribing SSRIs to pregnant women despite risks

Clinical trials

The British Medical Journal recently released several papers looking into the problem of unpublished data, including one study from Yale University, which found that fewer than half of the 635 the clinical trials funded by the National Institutes of Health were actually published in medical journals within 30 months of trial completion.

Drug companies that delay publishing these findings or even deliberately hide trial data are breaching their ethical duty, says lead researcher Joseph Ross. “The evidence we publish shows that the current situation is a disservice to research participants, patients, health systems, and the whole endeavor of clinical medicine,” he said.

Drug companies have often been caught withholding data, especially with drugs that are widely prescribed and bring in billions in profits. Drugmaker Grunenthal, now part of GlaxoSmithKline (GSK) and Sanofi, is currently being sued by 13 Americans who were born with birth defects after their mothers took the drug Thalidomide to treat morning sickness. The lawsuit claims that the drug company hid results of studies that would have revealed the drug caused birth defects.

Now, makers of the most commonly prescribed antidepressants are feeling some of the same wrath. New studies have linked selective serotonin reuptake inhibitors (SSRIs) to birth defects, particularly of the heart and lungs. Women who took the drug during pregnancy and gave birth to babies with these serious birth defects allege the drug companies did not reveal just how dangerous the drugs were to developing fetuses.

It wouldn’t be the first time these SSRI drug companies reportedly tried to cover up data that could hurt sales. In 2006, a U.S. court found drug maker GSK guilty of promoting Paxil or Paxil CR for children and adolescents while withholding and concealing information about the medication’s safety and effectiveness for minors. The lawsuit stemmed from a consumer advocate protest against GSK, which alleged that consumers were not sufficiently warned in advance of the drug’s side effects and addictive properties.

“Most clinicians assume that the complex regulatory systems that govern human research ensure that (clinical data) is relevant, reliable and properly disseminated,” Dr. Richard Lehman from Oxford University and the British Medical Journal’s Dr. Elizabeth Loder told the Daily Mail. “It generally comes as a shock to clinicians, and certainly to the public, to learn that this is far from the case.”

Sources:
Daily Mail
Wikipedia
The Dr. Rath Health Foundation

SOURCE: Paxil and Pregnancy › Do drug companies cover up data about drugs’ safety, efficacy?

The registries cover only about 28 percent of the overall population, and data from other areas beyond England and Wales is missing, so the accuracy of the results is still in question. What it does raise is questions about why the birth defect rate would increase.

Many factors can affect birth outcomes, several of which are considered preventable including lifestyle changes during pregnancy (such as smoking, and drug and alcohol abuse) and getting regular prenatal care. What some women don’t realize is that the prescription medication they are taking while pregnant could have detrimental affects on developing fetuses.

For example, one of the most prescribed drugs in both the United States and the United Kingdom is a type of antidepressant known as selective serotonin reuptake inhibitors, or SSRIs. Drugs in this class include Paxil, Zoloft, Celexa, Lexapro and Prozac.

Most of these drugs are labeled as safe to take during pregnancy; however, newer studies are providing more evidence that using them during pregnancy could increase the risk for heart defects, neural tube defects (including spina bifida) and other defects, including gastroschisis.

Source: The Independent

SOURCE: Paxil and Pregnancy › Could SSRIs be contributing to an increase in birth defects?

For some drugs, continuing to take them during pregnancy isn’t an issue. But other drugs have been shown to cause serious complications. Women may have to choose between continuing on a medication or having a baby. Otherwise, the baby could be at serious risk.

Antidepressants are one of the most prescribed medications in the country, and the most popular antidepressants include a category of drugs known as selective serotonin reuptake inhibitors, or SSRIs. These drugs include the brand names Paxil, Zoloft, Celexa, Lexapro and Prozac.

The Food and Drug Administration (FDA) is quickly learning more and more about these medications and their potential effects on unborn children. In fact, the FDA recently reclassified Paxil as a Category D pregnancy drug after data showed that some women who took Paxil delivered babies with birth defects. Newer studies also suggest that other SSRI drugs may be just as dangerous.

This new information has also resulted in lawsuits against the makers of some SSRIs for not adequately warning women of the potential for birth defects when taking the medication during pregnancy.

The bottom line, Ashton says, is understanding the risks and benefits with any medication, especially if you become pregnant.

Source: The Safety Report

SOURCE: Paxil and Pregnancy › Pregnant women should discuss prescription meds with their doctors

The plaintiffs allege that their children were born with varying birth defects including heart defects, neural tube defects, gastroschisis, omphalocele, craniosynostosis, cleft lip, club foot, anal atresia, and limb reduction defects. They blame the drug.

“Pfizer knew or should have known that Zoloft crosses the placenta, which could have important implications for the developing fetus,” the lawsuit states. The plaintiffs allege that Pfizer instead marketed Zoloft as the safest antidepressant to take during pregnancy.

Zoloft is in a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. Other drugs in this class include Paxil, Celexa, Lexapro, and Prozac. All SSRIs were classified as Category C pregnancy drugs, meaning that no studies have proven risks to developing fetuses. However, recent studies proving Paxil causes birth defects have required the reclassification of Paxil to a Category D pregnancy drug.

SSRIs are among the most prescribed medications in the country, and drug companies make millions off these drugs. The plaintiffs in the Zoloft lawsuit claim that Pfizer kept reports of complications in fetuses under wraps to protect its empire. The drug maker disputes these claims.

The lawsuit alleges strict products liability, breach of express warranty, negligence, misrepresentation by omission, negligent misrepresentation, fraud and misrepresentation, fraud by concealment, violation of consumer protection laws, and breach of implied warranties. The lawsuit seeks unspecified compensatory damages, statutory remedies, a disgorgement of profits and pre-judgment interests.

Attorneys with Beasley Allen Law Firm are currently investigating cases of birth defects allegedly associated with Zoloft and any other SSRI.

Source: The Madison St. Clair Record

SOURCE: Paxil and Pregnancy › Parents file birth defects lawsuit against makers of Zoloft

SSRIs are among the most prescribed medications in the United States and are the most poplar antidepressants prescribed in recent years. Little data was available to determine the risks on fetuses, thus many women were under the assumption that the drugs were safe. However, studies began to question that safety record.

Most of the concern focused on paroxetine, known by the brand name Paxil. Earlier studies resulted in Paxil being downgraded to a Category D pregnancy drug, meaning studies have shown the drug can cause birth defects if used during pregnancy.

The latest study suggests other SSRIs, including Zoloft, Celexa, Lexapro and Prozac, may be just as dangerous to developing fetuses. Researchers reviewed data from nationwide birth registries covering 11 years. The cohort included 635,583 babies, of whom 6,976 were exposed to SSRIs during the first trimester. The data showed that babies exposed to SSRIs were at greater risk for major cardiovascular anomalies than babies who were not exposed to SSRIs during gestation.

Specific defects linked to SSRI exposure include ventricular septal defects and right ventricular outflow tract defects. There was also a risk for neural tube defects.

The study also found that fetal alcohol syndrome disorders were nearly 10 times mere common in SSRI-exposed babies than in unexposed children. Therefore, the researchers advised, special attention should be given to alcohol use in pregnant women who use SSRIs.

Source: MedScape

SOURCE: Paxil and Pregnancy › Study raises more concerns about SSRIs and birth defects

The study looked at data from 27,058 patients aged 50 and older who were discharged from the hospital after a heart attack between January 1998 and March 2007. Following discharge, 14,426of the patients took aspirin alone and 406 took both aspirin and an SSRI at the same time.

Patients taking both the aspirin and the SSRI had a 42 percent increased risk of experiencing a bleeding episode such as gastrointestinal bleeding, hemorrhagic stroke, or other bleeding that required hospitalization, compared with those taking aspirin only.

When researchers included the blood thinner clopidogrel with aspirin, the risk of bleeding increased to 49 percent beyond aspirin alone. The addition of an SSRI brought the risk to 57 percent.

Blood thinners are commonly prescribed following a heart attack, and antidepressants are often prescribed to treat depression in patients with cardiovascular disease. But the study’s authors advised caution.

SSRIs include the brand names Paxil, Zoloft, Lexapro, Celexa and Prozac. The drugs are currently being investigated by attorneys with Beasley Allen Law Firm for possibly increasing the risk of serious birth defects when used by women during pregnancy.

Source: Food Consumer

SOURCE: Paxil and Pregnancy › Aspirin + SSRIs = risk of bleeding

This month, 13 Americans are suing Grunethal GmbH and companies now merged into GlaxoSmithKline and Sanofi, claiming the drug companies conspired to withhold the results of studies that showed their drug Thalidomide, used to treat morning sickness in pregnant women, caused birth defects, including missing and malformed limbs.

The plaintiffs were all born with birth defects between 1957 and 1962. The drug companies claim that the birth defects associated with Thalidomide were known in Europe, and that they could not have happened in the United States because the drug was only used in a limited clinical trial. The drug companies allege that the link between birth defects and Thalidomide was not known until 1961, however the lawsuits claim the companies were aware of the risks as early as 1955.

It’s taken 50 years for the victims of Thalidomide to seek justice, but lawsuits are already mounting against manufacturers of another class of drugs that studies show may cause serious birth defects – selective serotonin reuptake inhibitors, or SSRIs. These antidepressants are among the most prescribed medications in America, and many women are under the belief that these drugs are safe to use during pregnancy.

The truth is drug companies do receive complaints about their medication but are often slow to share the news. For example, women who used the SSRI Paxil during pregnancy and delivered babies with serious brain, heart and lung defects found out too late that their babies could have been spared injury if only they had been made aware of the possible risks associated with the drug.

It took several complaints for the Food and Drug Administration (FDA) to order stronger warnings on Paxil use during pregnancy. Many of those mothers are waiting for their day in court.

Source: Business Week

SOURCE: Paxil and Pregnancy › Drug companies should not hide risk for birth defects

The Hodges claim that before Susan became pregnant, Pfizer knew of the dangerous birth defects associated with using Zoloft during pregnancy from preclinical studies and subsequent published studies that confirmed the risks. Yet, the drug company took no action to adequately warn of the risks or fix the problem. Instead, the company “concealed, suppressed, and failed to disclose the dangers,” according to the Hodges’ lawsuit.

Zoloft is in a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. Other drugs in this class include Paxil, Celexa, Lexapro and Prozac. All SSRIs except Paxil are classified as Category C drugs, meaning there are no sufficient studies to rule out the risk of birth defects. Paxil was recently re-classified as a Category D drug after studies proved using the drug caused birth defects, including neural tube defects.

The lawsuit claims that “Pfizer had the knowledge, the means, and the duty to provide the medical community and the consuming public with stronger warning regarding the association between Zoloft and congenital birth defects … through all means necessary, including, but not limited to, labeling, continuing education, symposiums, posters, sales calls to doctors, advertisements, and promotional materials, etc. Pfizer breached this duty.”

The Hodges seek punitive damages for product liability, negligence, fraud, breach of warranty, unjust enrichment, false advertising and wrongful death.

Source: Opposing Views

SOURCE: Paxil and Pregnancy › Family claims Pfizer covered up birth defects risks with Zoloft

It was four years ago, and studies were beginning to show just how dangerous Paxil is to developing fetuses. The drug was linked to serious birth defects of the heart and lungs as well as neural tube defects. Those studies recently resulted in the reclassification of Paxil from a Category C to a Category D drug – a rating given by the Food and Drug Administration (FDA) to inform doctors and patients of birth defects associated with certain drugs.

Paxil is in a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. They are among the most prescribed drugs in the country. Paxil is the only SSRI classified as a Category D drug. All other SSRIs, such as Zoloft, Celexa, Lexapro, and Prozac, are classified as Category C drugs. The difference between the two categories is that studies prove that Category D drugs cause birth defects in humans, whereas with Category C drugs, there is not enough evidence to rule out the risk.

Taylor tried to wean off Paxil before becoming pregnant, but she fell into a deep depression. Last year, after she and her husband decided they were ready to start a family, Taylor returned to her doctor, this time asking for an alternative to Paxil. She just couldn’t risk being without an antidepressant. Her doctor recommended Zoloft.

Taylor’s visit to her doctor came just months before new studies suggested Zoloft – and other SSRIs – may be just as dangerous to developing fetuses as Paxil. Taylor says she had no choice but to take the risk. Taylor’s baby was born with pneumonia, a condition doctors didn’t associate with any cause, “but antidepressants never enter(ed) the conversation,” she said. Still, her infant daughter must stay in the NICU until she recovers.

“We’ll leave the hospital days before she will. We’ll drive home with an empty car seat and stare at an empty bassinet,” she writes. “My Zoloft, even if I don’t like it as much as Paxil, will come in handy.”

Source: Babble

SOURCE: Paxil and Pregnancy › Mother weighs risks of Zoloft during pregnancy

Kaiser Permanente recently published a study that suggests that exposure to a commonly prescribed type of antidepressant during the first trimester of pregnancy can increase the risk of a child developing autism. This type of antidepressant is known as selective serotonin reuptake inhibitor (SSRI) and includes brand-name drugs such as Zoloft, Paxil, Celexa, Lexapro and Prozac.

The safety of SSRIs on developing fetuses has been debated for the past few years with many researchers arguing that safety has not been established in clinical trials. The decision often falls on expectant mothers and their doctors, who often do not have the latest information on the studies or safety reports on antidepressants during pregnancy.

The truth is, recent studies have proven that at least one SSRI, Paxil, can cause serious birth defects, including heart defects, neural tube defects and lung defects. Side effects reported to the FDA show that other SSRIs may be just as dangerous. This latest study linking SSRIs to autism raises even more red flags about the safety of using SSRIs during pregnancy.

Source: Hive Health Media

SOURCE: Paxil and Pregnancy › Study suggests link between autism and SSRI use during pregnancy

But when drug companies cover up studies that suggest that their drug may actually put fetuses at risk for serious birth defects, it can have devastating consequences.

Such claims are being made about of the makers of some drugs in a popular class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. The drugs, known by the brand names Zoloft, Celexa, Lexapro and Prozac, are classified as Category C pregnancy drugs, meaning there are no studies that show how the drugs affect developing fetuses.

Paxil is the only SSRI that is classified as a Category D pregnancy drug, meaning studies have proven the drug can cause birth defects of the brain, spinal cord, heart, and lungs.

With little information to go by, and fear that their symptoms of depression may return, many women trust the packaging on their antidepressant bottle to reassure them that their baby will be OK. But the truth can be difficult to decipher.

Recent studies have suggested that all SSRIs may be as dangerous as Paxil, and a recent report in the Archives of General Psychiatry suggested that pregnant women who use SSRIs may be more likely to have a baby with an autism spectrum disorder.

So whom can a woman trust?

“In pregnancy in general, we tend to be afraid of all medications,” says Dr. Lori Wroble, the chief obstetrician for Harvard Vanguard Medical Associate at Newton-Wellesley Hospital. “And I think it’s actually scarier when you don’t have enough studies, because it’s an open-ended question that you’ll always wonder about.”

Source: The Pregnancy Blog

SOURCE: Paxil and Pregnancy › Women should use caution with SSRI use during pregnancy

The Hodges baby was born with a defect known as anencephaly, in which a large part of the brain and skull are missing. The condition is almost always fatal.

Zoloft is an antidepressant in a drug class known as selective serotonin reuptake inhibitor (SSRI). Other drugs in this class include Paxil, Celexa, Lexapro and Prozac. Almost all SSRIs are classified as Category C drugs, meaning that there is not enough evidence to determine whether the drugs cause birth defects.

Paxil is the only SSRI that is not classified as a Category C drug. It was recently reclassified as a Category D drug, meaning the drug has been proven to cause birth defects in humans and should only be used if the benefits to the mother outweigh the risks. The reclassification of Paxil was the result of new studies that showed the drug increased the risk of heart, brain, spinal cord and lung defects in newborns if used during pregnancy.

The Hodges claim Zoloft carries similar dangers and that before Susan Hodges began taking the drug Pfizer knew of the serious birth defects associated with Zoloft’s use during pregnancy from preclinical studies and subsequent published studies. Despite this, they say, Pfizer took no action to adequately warn consumers of the potential risks. Instead, the company took measures to conceal the dangers, their lawsuit alleges.

The Hodges are seeking punitive damages for product liability, negligence, fraud, breach of warranty, unjust enrichment, false adverting, and wrongful death.

Source: Courthouse News Service

SOURCE: Paxil and Pregnancy › Parents claim Zoloft caused newborn’s fatal neural tube defect

SSRIs are among the most commonly prescribed drugs in the United States and include brand names such as Zoloft, Paxil, Effexor, Celexa and Prozac. The popularity of these drugs has eclipsed the sale of older, generally less expensive tricyclic antidepressants.

Both types of antidepressants are considered equally effective and were considered equally as safe as well. However, a study published in a recent issue of the British Medical Journal suggests otherwise.

The study used data from a large collection of anonymous health records called Q Research to pit the two types of antidepressants together. They found that among the 60,000 people in the study who were older than 65 and suffered from depression, the patients taking the older tricyclic antidepressants had a lower death risk than patients who took the more modern SSRIs.

The study also found serotonin-triggering antidepressants were associated with a higher risk of attempted suicide. SSRIs currently have a black box warning that use, especially in children and adolescents, may cause suicidal ideation and patients using the drugs should be monitored for signs of bizarre or depressive behavior.

The new study casts a darker shadow on the safety of SSRIs. Elderly patients who use SSRIs are encouraged to discuss any concerns with their doctors. Any side effects with these or any drugs should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: Third Age

SOURCE: Paxil and Pregnancy › Study: SSRIs may be dangerous to elderly

An autopsy did not determine the cause of death, but it did list as a contributing factor the antidepressant drug Effexor his mother Christiane was taking during her pregnancy. Now the Schultzes want to warn others of the dangers of using antidepressant during pregnancy.

Effexor is type of antidepressant known as selective serotonin reuptake inhibitor (SSRI). SSRIs are the most commonly prescribed antidepressants on the market today and include popular brand-names such as Zoloft, Paxil, Celexa and Prozac. Almost all SSRIs fall into Category C, a classification that tells doctors whether drugs are safe to use during pregnancy. Category C drugs are ones in which there have not be sufficient tests to determine the drug is safe for developing fetuses.

Paxil is the only SSRI that has been classified as a Category D drug, meaning studies have proven the drug can cause birth defects. Paxil’s recent re-classification from Category C to Category D was the result of recent studies that showed the drug contributed to serious birth defects including serious and life threatening heart and lung defects.

Studies like these add more pain to the Schultzes, who now realize that something might have been done to spare their child’s life. If only the drug companies were more forthcoming about the real dangers of SSRI use in pregnant women, they say.

“Every time I got pregnant I asked, ‘Should I wean? Should I get off of these?’” Christiane said. “I was actually encouraged to stay on them because, what if you get depressed while you’re pregnant?”

Source: CBC News

SOURCE: Paxil and Pregnancy › Autopsy suggests SSRI may have contributed to newborn’s death

Researchers at Yale School of Medicine followed a group of 778 pregnant women with a history of depression who decided independently whether or not to continue antidepressant medication throughout their term. The study was based on a larger cohort of 3,000 women, all over 18, with a history of depression.

The cohort tracked the women through pregnancy and the post-partum period. At least all women had experienced at least one depressive episode prior to becoming pregnant. The study found 21 percent of the 3,000 women followed were taking antidepressants at the start of their pregnancy. Only 14 remained on their medications by their second trimester.

Many of the women said the decision to discontinue taking antidepressants once they became pregnant was a difficult one. The most commonly prescribed antidepressants are known as selective serotonin reuptake inhibitors (SSRI), and are sold under brand names such as Zoloft, Paxil, Celexa and Prozac. New studies have shown that using SSRIs during pregnancy can cause serious birth defects of the brain, spinal cord, heart and lungs.

Source: Yale Daily News

SOURCE: Paxil and Pregnancy › Women should not fear discontinuing antidepressants while pregnant

Today, as many as one in six pregnant women in the United States are diagnosed with major depressive disorder, and most are given SSRIs to treat their symptoms. This class of drugs includes brand-name drugs such as Prozac, Zoloft and Paxil. Recent studies have reported problems with newborns whose mothers have used SSRIs, including increased pain sensitivity, heart and lung defects, and developmental malformations, which could be linked to the drug use.

For the Danish study, researchers identified about 400 women who took antidepressants during pregnancy as well as nearly 500 women who were depressed but not treated with medication. The researchers then documented and compared when children in each group hit developmental milestones, such as sitting without support, looking toward sounds, and venting irritation.

At six months of age, babies who were exposed to SSRIs in the second or third trimester were 26 percent more likely to sit on their own compared to 30 percent of babies who were not exposed to SSRIs. The babies exposed to antidepressants also took an average of 16 days longer to sit on their own and 29 days longer to walk than babies who were not exposed. By 19 months of age, the movement differences had vanished, although the children who were exposed to antidepressants had a slightly more difficult time occupying themselves without calling out for attention.

The study shows that not only might SSRIs affect the development of the fetus, “these drugs have an effect on the fetus’ brain,” said Dr. Lars Henning Pedersen, who worked on the study. Dr. Pedersen said he would like to see more studies exploring how babies exposed to antidepressants as fetuses fare later in life. He plans to do a study on the same group of babies once they reach their teens.

Source:
Reuters

SOURCE: Paxil and Pregnancy › Babies exposed to SSRIs may reach developmental milestones late

Paxil is in a class of drugs known as selective serotonin reuptake inhibitors, or SSRIs. Other drugs in this class include Zoloft, Celexa, Lexapro and Prozac. When Paxil was approved by the Food and Drug Administration (FDA) in 1992 for the treatment of depression and anxiety disorders, it was listed as a Category C pregnancy drug, meaning that there have been no studies to show whether the drug could harm fetuses. However, reports of birth defects including those affecting the heart, lungs and other organs, from women who took the drug while pregnant were enough for the FDA to require the drug be reclassified as a Category D drug, meaning studies have proven that use during pregnancy can cause birth defects.

Since the drug was approved, more than 600 cases alleging birth defects linked to Paxil have been filed. The first trial resulted in a verdict for the plaintiffs and an award of $2.5 million in compensatory damages for the family of Lyam Kilker, who was born with three cardiac birth defects after his mother took Paxil while pregnant.

While Paxil is the only SSRI classified as a Category D drug, newer studies are beginning to question the safety of other SSRIs on fetuses, particularly Zoloft. Two studies published in the New England Journal of Medicine found a statistically significant increased risk of various birth defects possibly linked to Zoloft. Canadian and Swedish studies backed up that claim, singling out persistent pulmonary hypertension as a potentially fatal condition from SSRI exposure.

Animal experiments have also shown that not only do SSRIs pass through the placental barrier, they have direct effects on the developing neural crest and brachial arch cells that migrate in a very early developing embryo to form all of the major organ systems in babies. When neural crest cells don’t migrate properly or they’re interfered with by an agent such as Paxil or Zoloft, many problems can arise.

More and more lawsuits filed against makers of SSRIs are holding these drug companies accountable for their actions in response to these studies, and their responsibility to adequately warn users of the potential dangers of their drugs.

Source:
Dissident Voice/Bloomberg

SOURCE: Paxil and Pregnancy › Paxil lawsuits have cost drug maker $1 billion

Pregnant women

The study involved nearly 3,000 women who gave birth in Washington state. Researchers found that those who started taking antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, in the second or third trimester were nearly five times more likely to give birth prematurely compared to pregnant women not on the medication.

SSRIs are prescribed for the treatment of depression and anxiety disorders and include drugs such as Zoloft (sertraline), Paxil (paroxetine), and Prozac (fluoxetine).

The study raises more concerns about the safety of SSRIs during pregnancy. A New England Journal of Medicine study found that women who took SSRIs during their third trimester were six times more likely to deliver babies born with persistent pulmonary hypertension (PPHN), a serious lung condition, than those who did not take SSRI during their third trimester.

More studies have linked SSRIs to omphalocele, a birth defect where the intestine or other abdominal organs protrude from the naval. Other birth defects that have been reported include cleft palate, club foot, spina bifida, anal atresia, and congenital heart defects.

Beasley Allen Law Firm is currently investigating cases of birth defects and birth complications  allegedly caused by SSRI use during pregnancy. These lawsuits may provide the financial resources necessary for a lifetime of care or to help pay for medical procedures for babies that may have been affected by the drugs.

Source: American Journal of Obstetrics & Gynecology

SOURCE: Paxil and Pregnancy › Study links SSRIs to preterm delivery and birth complications

SSRIs include brand names such as Celexa, Lexapro, Prozac, Paxil, Zoloft and Symbayax. They work by blocking the reabsorption of the neurotransmitter serotonin in the brain. Adjusting the serotonin helps the brain cells send and receive chemical messages, which helps alleviate depressive emotions.

Recent studies have shown a link between SSRI use during pregnancy and birth defects, in particular heart and lung defects. Data from these studies led to the reclassification of Paxil from a Category C drug to a Category D drug, meaning it is not advised for use during pregnancy because of a proven risk for birth defects. Newer studies suggest other SSRIs should be reclassified as well.

The FDA’s latest safety communication warned doctors and patients that Celexa should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. These changes, known as prolongation of the QT interval on the electrocardiogram, or CECG, can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal.

Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood.

Any side effects with Celexa or any other SSRI should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA

SOURCE: Paxil and Pregnancy › FDA issues warning about SSRI Celexa in higher doses

It was the question posed recently on BabyCenter.com, a website resource for expectant mothers, new mothers, and women hoping to become pregnant in the near future. The question sparked numerous responses from women who were faced with making that decision. Some women commented that they needed the medication because they struggled with severe depression and anxiety. But they still worry about the effects the drug may have on their unborn babies.

The concerns are valid. Two recent studies reported that selective serotonin reuptake inhibitors (SSRIs), a commonly prescribed class of antidepressants, increase the risk for congenital malformations and developmental disorders among children whose mothers took SSRIs while pregnant.

The first study, published in the journal Obstetrics and Gynecology, found a two- to four-fold increased risk of cardiac and neural tube defects with some SSRIs, and fetal alcohol spectrum disorders were also 10 times more likely in children exposed to an SSRI while in the womb.

The second study, published in the Archives of General Psychiatry, found a two- to three-fold increase in autism spectrum disorders among children exposed to SSRIs during pregnancy. The risk was greater when the SSRI was used during the first trimester of pregnancy.

Most SSRIs are classified as Category C drugs, meaning that either studies in animals have shown adverse affects on the fetus but there are no controlled studies in women, or studies in women and animals are not available. These drugs are only given if the potential benefit justifies the potential risk to the fetus.

Paxil is the only SSRI classified as a Category D drug, meaning that there is positive evidence of fetal risk in humans when used during pregnancy. The classification was only recently downgraded. While dangerous to fetuses, the FDA says these drugs may be acceptable if they are needed in a life-threatening situation or for a serious disease where safer drugs cannot be used or are ineffective.

Source: www.BabyCenter.com

SOURCE: Paxil and Pregnancy › Women question safety of antidepressants while pregnant

The Schultzes and the Rawkins spoke to BC Local News in hopes of raising awareness of the dangers of using SSRIs like Effexor during pregnancy. They hope women who are considering becoming pregnant and doctors both heed their warning.

“The pathologists who performed autopsies on both of our sons brought this to both of our attention. The drug was present in both of their systems and their are hundreds of reported adverse reactions in newborns related to these drugs, including over a dozen cases of infant death, which the coroner was absolutely wrong in saying that infant death doesn’t occur,” Amery commented. “Health Canada published very strong warnings in 2004 and 2006 that never made their way to doctors or the end consumer. I don’t believe that we will ever prove causation, but the existence of having a birthing protocol and monitoring of these exposed babies certainly could have saved my Matthew’s life.”

Effexor and all other SSRI medications except Paxil are listed as Pregnancy Category C drugs, meaning that either studies in animals have revealed adverse affects on the fetus and there are no controlled studies in women, or studies in women and animals are not available. These drugs are only given if the potential benefit justifies the potential risk to the fetus.

Paxil is the only SSRI listed as a Category D drug, meaning that there is positive evidence of human fetal risk when used during pregnancy, but the drug may be acceptable if it is needed in a life-threatening situation or for a serious disease where safer drugs cannot be used or are ineffective. New studies that showed Paxil was more lethal than other SSRIs prompted its category downgrade, but some people, including the Schultzes and the Rawkins, worry that other drugs in the same class may pose similar dangers when used during pregnancy.

“We are fighting to protect babies. If a person who knows the facts about these drugs still wants to take them, then power to them. But it’s the gross ignorance around them that we are trying to change. Doctors will tell you they’re safe, and not to worry about any warnings that you may hear. But they don’t know. The vast majority of doctors only have knowledge of drugs either from a drug sales rep that visits them at their office or from a Continuing Medical Education (CME) Seminar that is sponsored by a drug company, and usually somewhere nice like a golf resort or Hawaii,” Amery continued.

“Drug companies do not put patient safety first, they put shareholder equity first. Plain and simple. Death and debilitating side effects are the norm for a drug company to operate. It is collateral damage. In the last decade alone, pharmaceutical companies have settled billions of dollars in lawsuits. Once settled, those injured by dangerous drugs are silenced and their stories are removed from the public record. It’s the cost of doing business for a drug company. It makes sense to pay out 1 billion dollars in a class action settlement if a drug makes you 2 billion a year in profit. simple economics.

“And our Healthcare system, notably Health Canada is powerless to stop this from happening,” Amery said.

Source: BC Local News

SOURCE: Paxil and Pregnancy › Families warn of dangers with using SSRIs during pregnancy

The study, which was published in the Health Affairs journal, was co-authored by Mark Olfson, a professor of clinical psychiatry at Columbia University. The results were reported by the Wall Street Journal.

Antidepressants were the second-most widely prescribed class of drugs in 2010, second only to cholesterol-lowering statins. Zoloft or a generic version of the drug known as sertraline was the most prescribed antidepressant with 36 million prescriptions written in 2010.

Zoloft is in a class of drugs known as selective serotonin reuptake inhibitors (SSRIs), and are approved by the Food and Drug Administration (FDA) to treat depression, anxiety disorders and some personality disorders. Other drugs in the class include Paxil, Celexa, Lexapro, and Prozac.

A 2010 meta-analysis of SSRIs found that the drugs worked best for patients with severe depression. Patients with mild or moderate symptoms may receive little or no benefit from the medication. Yet, taking SSRIs put users at risk for side effects that include nausea and vomiting, headache, strange dreams, changes in appetite and weight, changes in sexual behavior, increased feelings of depression and anxiety which may provoke panic attacks, and suicidal ideation.

The drugs also put expectant mothers at risk for delivering a baby with serious birth defects. SSRIs cross the placenta and have been associated with congenital malformations, in particular septal defects. Some evidence suggests that SSRIs are linked to neonatal abstinence syndrome and persistent pulmonary hypertension.

All SSRIs except Paxil are listed as Pregnancy Category C drugs, meaning that risk cannot be ruled out because adequate, well-controlled human studies are lacking and animal studies may or may not have shown a risk to the fetus. Paxil was recent downgraded from a Category C to a Category D drug, indicating that there is positive evidence of risk to fetuses.

Source: Wall Street Journal

SOURCE: Paxil and Pregnancy › Widely used SSRIs raise concerns of birth defects

GlaxoSmithKline

Paxil is a type of medication known as selective serotonin reuptake inhibitors (SSRIs), and is prescribed for the treatment of depression and anxiety disorder. Other brands of SSRIs include Zoloft, Lexapro, Prosac and Celexa. Paxil is considered more toxic to unborn babies than any other SSRI, and is listed as a Category D drug. All other SSRI drugs are Category C drugs, meaning they are safer for use during pregnancy.

Since 2005, studies have linked Paxil to birth defects including cardiac (heart) defects, pulmonary (lung) defects, neural tube defects (brain and spinal cord), craniosynostosis (abnormally shaped skull), infant omphalocele (abdominal wall defects), club foot (one or both feet turn downward and inward), and anal atresia (complete or partial closure of the anus).

Newer studies also have linked the antidepressant to an increased risk of Neonatal Persistent Pulmonary Hypertension (PPHN).

More recent studies have also linked serious birth defects with other types of SSRIs, which has led some people to question whether all SSRIs should be labeled as Category D drugs and avoided during pregnancy.

Anyone who has taken an SSRI during pregnancy and delivered a child with a birth defect may have a case against the drug’s maker.

SOURCE: Paxil and Pregnancy › Millions awarded to women in Paxil, birth defects lawsuits

The study showed that women taking fluoxetine, known by the brand name Prozac, in early pregnancy is associated with a two-fold increased risk for isolated ventricular septal defects, while paroxetine, also known as Paxil, was associated with a four-fold increased risk for right ventricular outflow tract defects. Both are defects with the heart.

The study involved 635,583 babies, of whom 6,976 had first-trimester exposure to SSRIs. SSRIs are a class of antidepressants prescribed to treat depression, anxiety disorder, and some personality disorders. They are the most prescribed antidepressants in the country.

Heli Malm, MD, PhD, from the Teratology Information Service at Helsinki University Central Hospital in Finland, where the study was conducted, said prescribing SSRIs to pregnant women should be banned because of the serious risks it poses to fetuses.

The FDA recommends that women talk to their doctor before stopping use of any medication.

Source: TopNews New Zealand

SOURCE: Paxil and Pregnancy › Paxil use during pregnancy increases risk for serious heart defects

What concerns doctors is that many of these medications have never been studied in pregnant women to determine if use during pregnancy increases birth defect risk. This gray area puts the decision of whether to use medications in the hands of women and their doctors. Often, drug companies rely on information from animal trials when data from human trials is not available. But that can be misleading.

Such is the case with Paxil. Once labeled as a Category C drug, the drug was not associated with birth defect risks and thus was thought somewhat safe to use at least during the later months of pregnancy. However, this was proven to be false after the Food and Drug Administration (FDA) began receiving reports from women who took the antidepressant and had babies born with defects, in particular heart defects. Lawsuits soon followed.

Paxil has since been classified as a Category D drug, one that is not deemed safe to use during pregnancy. But all other antidepressants in the same class, known as selective serotonin reuptake inhibitors (SSRIs), still are classified as a Category C drug, and are still prescribed to pregnant women suffering from depression and anxiety disorder. Studies show that these drugs, which include the brand Zoloft, are just as dangerous to developing fetuses.

Women who are pregnant or are considering becoming pregnant should discuss with their doctors whether the risks and benefits of the drugs they take in order to determine whether they are safe for their unborn babies.

Source: Fox News

SOURCE: Paxil and Pregnancy › Most pregnant women taking medication despite possible risks

“To say the least, I was absolutely distraught with this news. I thought this was something that I did … because I stayed on the Paxil for selfish reasons,” Beverly said. Despite the heartbreaking loss, Beverly and her husband were ready to try again to get pregnant. Her e-mail to GSK continued, “I don’t want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby, I want to know upfront. And I will somehow stop taking it for the time being.

“Please contact me as soon as possible. Please don’t forget about me.”

GSK never responded. Three weeks later, Beverly sent another e-mail, this time asking specifically, “I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.”

Five days later, Beverly got a response. GSK attached a copy of its current product information for Paxil, and then suggested she contact her physician or pharmacist with any questions.

Eight years later, the first Paxil birth defect trial resulted in a $2.5 million verdict against GSK. Since then, hundreds of lawsuits have been filed against GSK, and the FDA downgraded Paxil’s status from a Category C to a Category D drug, indicating clinical trials showed the drug caused birth defects in developing fetuses.

Paxil, an antidepressant in a class of drugs known as selective serotonin reuptake inhibitors, or SSRIs, is the only SSRI listed as a Category D drug. But new studies suggest that Zoloft, another SSRI, and others in the class, may be just as dangerous to fetuses when used by mothers during pregnancy.

Beasley Allen Law Firm is currently investigating cases where SSRIs may have caused birth defects.

*Name changed
Source: Unite for Life

SOURCE: Paxil and Pregnancy › GSK avoided questions about safety of Paxil during pregnancy

Lyam’s parents filed suit against GlaxoSmithKline (GSK) claiming the drug company failed to adequately warn users of the risks associated with using Paxil while pregnant. The trial resulted in a landmark $2.5 million verdict against the pharmaceutical company.

Hundreds of more lawsuits were filed against GSK, and for the second quarter of 2010, GSK announced legal charges of about $2.4 billion. Soon, lawsuits against other antidepressants began to surface suggesting other antidepressants in the class were just as likely to cause birth defects.

Paxil has since been downgraded from a Category C drug to a Category D. Category D means that studies in pregnant women have demonstrated risk to the fetus. Paxil is in a class of antidepressants known as SSRIs, or selective serotonin reuptake inhibitors.

All other SSRIs are currently listed as Category C drugs, meaning the drugs have been shown to harm fetuses in animal studies but have not been adequately studied in humans. With Category C medications, doctors and patients must decide if the benefits are greater than the risks. However, new studies suggest that other types of SSRIs may be more dangerous to developing fetuses than previously thought.

Pregnant women or women considering pregnancy should discuss with their doctors any concerns they have about SSRIs and birth defects, and whether the benefits of taking the drug outweigh the possible risks to the fetus.

Source: Unite for Life

SOURCE: Paxil and Pregnancy › Other SSRIs may be just as dangerous as Paxil to fetuses

These studies showed an increased risk for all congenital malformations with SSRIs and particularly with paroxetine, known by the brand name Paxil. A few studies after 2005 have also found an association between prenatal exposure to SSRIs (especially paroxetin) and congenital malformations.

Exposure to SSRIs in late pregnancy has been associated with a three-fold increased risk of neonatal behavioral syndrome, including signs of withdrawal or serotonin impregnation. Restlessness, poor tone, respiratory distress, and hypoglycemia were the most frequent signs. These symptoms occur during the first days of life and are usually brief and not serious.

Recent studies have also documented an increased risk of persistent pulmonary hypertension and cases of cerebral hemorrhage, which can be life threatening.

“In practice, the potential risk implies that the decision to treat a pregnant woman with SSRIs (notably paroxetin) should be taken carefully; this means double-checking the diagnosis, the potential benefits, adverse effects and possible alternatives. Neonatal toxicity seems to be relatively frequent when SSRIs are prescribed during late pregnancy,” the researchers wrote. “For all depressed pregnant women, the severity of the depression must be taken into consideration before introducing a pharmacological treatment.”

Source: PubMed

SOURCE: Paxil and Pregnancy › SSRIs, especially Paxil, dangerous to unborn babies

Paxil, manufactured by GlaxoSmithKline (GSK), is an antidepressant in a class of medications called selective serotonin reuptake inhibitors (SSRIs), which work by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance. It is used to treat depression, panic disorder, and social anxiety disorder. The medication is also used to treat chronic headaches, tingling in the hands and feet caused by diabetes, and certain male sexual problems. It is also used in combination with other medications to treat bipolar disorder. It may also be prescribed for other uses.

The drug’s safety label now warns patients that, “epidemiological studies have shown that infants born to women who had first trimester paroxetine exposure had an increased risk of cardiovascular malformations, primarily ventricular and atrial septal defects (VSDs and ASDs). In general, septal defects range from those that are symptomatic and may require surgery to those that are asymptomatic and may resolve spontaneously. If a patient becomes pregnant while taking paroxetine, she should be advised of the potential harm to the fetus. … For women who intend to become pregnant or are in their first trimester of pregnancy, paroxetine should only be initiated after consideration of the other available treatment options.”

In 2005, when the FDA first warned of the dangers with Paxil in women of childbearing age, GSK was ordered to change the pregnancy category of the drug from C to the stronger warning of D. Category D means that studies in pregnant women (controlled or observed) have demonstrated a risk to the fetus.

In 2010, a new study using the Swedish Medical Birth Register from July 1, 1995 to 2007 identified women who reported the use of antidepressants in early pregnancy or were prescribed antidepressants during pregnancy by antenatal care. Data showed a specific association between Paxil use and infant cardiovascular defects. There was also a strong association between Paxil and hypospadias, a birth defect of the urethra in male infants. The drug has also been associated with an increased risk for spontaneous miscarriage.

Beasley Allen Law Firm is currently investigating cases of birth defects caused by Paxil, or generic versions of the drug, known as paroxetine.

Source: FDA

SOURCE: Paxil and Pregnancy › New study shows Paxil during pregnancy causes heart defects

An estimated 16 percent of woman will experience symptoms of depression, known as postpartum depression (PPD), during the first year after giving birth. If left untreated, PPD can have serious consequences for both the mother and her newborn child. The newborn may experience lower APGAR scores, failure to thrive, and poor physical, emotional and behavioral development for the baby.

But more and more attention is being paid to antenatal depression, or depression during pregnancy. Nearly one-fourth of women experience antenatal depression. Maternal depression can lead to poor maternal self-care, increased risk-taking behavior and poor pregnancy outcomes.

Treatment often comes in the form of a pill, or antidepressant. But the APA/ACOG review report indicates that symptoms of depression and antidepressant use during pregnancy may lead to serious problems for the baby, including preterm delivery, low birth weight and birth defects. Weighing the best treatment should be approached individually with each patient.

For example, a recent scientific study indicated that antidepressants taken during the first trimester increased the risk of birth defects. Some drugs, such as Paxil (paroxetine), had even a greater risk of birth defects, in particular defects of the heart, when taken during the first three months of pregnancy.

The report recommends that given the potential for serious consequences from antidepressant use during pregnancy, some women who are pregnant or considering pregnancy should taper or discontinue therapy to reduce their risk. Women who have mild or no depressive symptoms for six months should consider discontinuing treatment with antidepressants before becoming pregnant. For these women, psychotherapy may be a safer treatment plan.

Women with suicidal or acute psychotic symptoms should optimize their therapy and consult with a therapist about adjusting their antidepressant therapy before becoming pregnant. For these women, the risks associated with untreated depression may outweigh the potential harm to the unborn baby. If at all possible, antiepileptic agents, which are often used with patients with severe symptoms of depression and psychosis, should be avoided for the first three months of pregnancy.

The report further encourages women who suffer from depression who are pregnant or thinking about becoming pregnant to discuss treatment options with their physician or trained clinician to ensure a safe and healthy pregnancy.

SOURCE: Paxil and Pregnancy › Treatment guidelines for women before, during pregnancy

“GSK knew it was not safe to take Paxil (during pregnancy) but said nothing,” his parents say in a video on YouTube. Now Manie has a broken heart, and a scar that runs down the center of his chest. He holds a sign against his scarred chest. It reads, “Why?”

“How many more babies will suffer,” they ask. “Answer this, GSK, please.”

In September 2005, a study on infants born to women taking antidepressants, including Paxil, during the first trimester of pregnancy, revealed a greater risk for overall birth defects and an increased risks for heart defects specifically. Following the study, GSK updated the PRECAUTIONS subsection of its label for Paxil to include the risk of birth defects, including heart defects.

“Do the benefits outweigh the risks?” Manie’s parents ask.  “No. Never.”

What’s to become of Manie’s broken heart?

Read more of Manie’s story at bigpharmavictim.blogspot.com

Source: YouTube, jiedgi

SOURCE: Paxil and Pregnancy › Parents ask GSK: ‘How many more babies will suffer?’

The study, published earlier this year in the Journal of the American Medical Association, examined more than 11,000 low-income mothers in New Jersey. The data indicated that 9.6 percent of women with diabetes who had no indication of depression during pregnancy, developed depression during the year following delivery.

Researchers say that the findings do not establish that diabetes causes postpartum depression, only that the two are related and that health care professionals should consider the mental health of patients when dealing with low-income individuals with diabetes both during pregnancy and the postpartum period.

About 10-20 percent of women will struggle with some symptoms of depression during pregnancy, and a quarter to half of those will suffer major depression, according to the American Pregnancy Association. Untreated depression can have potential dangerous risks to both the mother and baby, leading to poor nutrition; dependence on alcohol, drugs or cigarettes, and suicidal behavior that can cause premature birth, low birth weight and developmental problems. Add maternal diabetes to the mix, and mothers can feel even more consumed by emotions.

While antidepressants can serve as a viable treatment for depression, women should discuss their options with their healthcare provider. Some SSRI medications, such as Paxil, have been shown to increase the risk of overall birth defects and in particular heart defects, when taken during pregnancy. As of September 2005, Paxil manufacturer GlaxoSmithKline has updated its precautions section on the Paxil labels to warn of the potential risk to babies when taken by mothers during the first trimester.

SOURCE: Paxil and Pregnancy › Women with diabetes more likely to suffer postpartum depression

Dr. Zachary Stowe, director of the Women’s Mental Health Program at Emory, is listed as the primary investigator on at least three National Institutes of Health grants that involve antidepressant use in pregnant women and the effects on children delivered by those women.

According to records, Dr. Stowe received payments totaling more than $250,000 between 2007 and 2008 from drugmaker GlaxoSmithKline PLC, during which time Dr. Stowe delivered at least 95 promotional talks on behalf of the drug company. Dr. Stowe contends his work with GlaxoSmithKline was not a conflict of interest and that such relationships are not uncommon in research.

Dr. Stowe is the second Emory researcher who has been reprimanded for not properly disclosing his financial arrangements with drug companies. Last fall, Dr. Charles Nemeroff resigned as chairman of Emory’s Department of Psychiatry for similar conflict of issues concerns.

Of heightened concern is GlaxoSmithKline’s antidepressant Paxil, which recent studies have shown have a greater risk of causing serious birth defects in the children of women who took the antidepressant during the first three months of pregnancy. As a result, GlaxoSmithKline updated the cautions section of Paxil to indicate the risk of overall birth defects, in particular heart defects.

Sources:
Atlanta Journal Constitution
Wall Street Journal

SOURCE: Paxil and Pregnancy › Psychiatrist reprimanded for taking money from drug maker

Pregnant woman and women who are trying to get pregnant are routinely prescribed prenatal vitamins containing at least 1,000 milligrams of folic acid as a way to improve the health of the unborn child. In the mid-1990s, the Food and Drug Administration (FDA) took the effort one step further, requiring that folic acid be added to breads, cereals, flours, corn meals, pastas, rice and other grain products. Researchers say that move likely contributed to the 26 percent drop in neural tube defects, according to the U.S. Centers for Disease Control and Prevention. Now they say folic acid also may be tied into the six percent drop in heart defects each year after folic acid was added to grain supplies, researchers say.

While congenital heart defects are rare, such news is encouraging. “If you can reduce such a significant abnormality by doing something as simple as a public health intervention by increasing folic acid in the grain supply and encouraging individuals to take folic acid supplementation, it’s a win-win situation,” said Dr. Diane M. Ashton, deputy medical director of the March of Dimes.

Besides consuming a folic acid supplement or consuming foods high in folic acid, another step a woman can take to improve her chances of having a healthy baby is to discuss with her doctors any medications she is taking. Some drugs, such as SSRI antidepressants like Paxil, have been linked to a an increased risk of overall birth defects, and specifically heart defects.

SOURCE: Paxil and Pregnancy › Folic acid may help reduce risk of heart defects in newborns

SSRIs (selective serotonin reuptake inhibitors) are antidepressants that affect serotonin levels in the brain. It’s not fully understood how they work but it is thought they provide higher levels of serotonin at the brain receptor site. SSRI discontinuation syndrome can occur during or following interruption or the lowering of dosage or the discontinuation of an SSRI or SNRI (serotonin-norepinephrine reuptake inhibitor) antidepressant.

Side effects can occur between 24 hours to one week after reduction or stoppage of dosage and they can be overwhelming. Side effects may include dizziness, electric shock-like sensations or “zaps,” sweating, nausea, insomnia, tremor, confusion, and vertigo.

If you are considering coming off your antidepressant, Summer Beretsky on PsychCentral.com offers some tips on how to make the process in a blog that details her challenges when she came off Paxil. Her weaning process was a months long ordeal that involved tapering down her dosage by splitting or shaving pills over the course of seven months. During that time of weaning off she says she suffered from side effects headaches, lethargy, depression, dizziness, the “zaps,” and nausea, to name a few. Read her personal story and tips on gradually weaning off SSRIs on the site’s blog.

SOURCE: Paxil and Pregnancy › Coming off antidepressants can take months of effort

One of the most important is to see your health care provider before getting pregnant so that she can evaluate your health and identify any health or lifestyle risks that may affect your pregnancy.

Your doctor will discuss various subjects with you. Here is what the March of Dimes says you can expect during your pre-pregnancy checkup:

1. Family History. A family history includes medical information about you, your partner and your families. If any of you have had birth defects or disorders, you may need to see a genetic counselor to asses any potential risks.

2. Medical Conditions. Some medical conditions, such as epilepsy, diabetes or high blood pressure may require you have special care during pregnancy.

3. Medications. If you take medications to treat any existing conditions, your provider may ask you to change to a drug that’s safer during pregnancy. Some medications taken during pregnancy, such as antidepressants, have been found to cause birth defects in babies.

4. Vaccinations. Chickenpox or rubella (German measles) during pregnancy can harm your baby. Your doctor will encourage you to be up-to-date on your immunizations. If you do not know if you are immune to a disease, your doctor can schedule a blood test to find out. If you need a shot, wait at lest one month after the shot before trying to conceive.

SOURCE: Paxil and Pregnancy › Pre-pregnancy checklist for women considering pregnancy

For the study, researchers observed a group of 300 pregnant women, most of whom did not suffer from depression but some either had a history of depression or reported becoming depressed during pregnancy. Of those observed, some took medication to treat their depression either for part of their pregnancy or for the entire pregnancy; some did not take medication and remained depressed; and some did not take medication and reported being depressed for only part of their pregnancy.

The research found that the women who took medication for the duration of their pregnancy and the women who did not take medication but still suffered with depression had a much higher rate of premature birth (20 percent) than the women who took no medication and recovered from their depression during their pregnancy (4 to 9 percent).

Antidepressants can also carry others risks to unborn babies. A 2005 scientific study showed a link between birth defects in babies born to women who took antidepressants during pregnancy. The recurrence was rare enough that some antidepressants are still considered viable options for pregnant women.

However, one antidepressant showed a greater risk to unborn children in the first trimester over other antidepressants, Paxil. As a result of the study, drug manufacturer GlaxoSmithKline updated the PRECAUTIONS subsection on the labeling for its popular antidepressant Paxil, citing a greater risk for overall birth defects, in particular heart defects.

Women who are pregnant or are considering becoming pregnant should consult with their doctors to determine what depression treatment is best for them.

SOURCE: Paxil and Pregnancy › Study: antidepressants, depression linked to preterm birth

Seeking help from a health care provider is vital not only to the mother, but to her unborn child. Depressed mothers-to-be may not have the energy to take care of themselves or seek optimal prenatal care. She may even rely on smoking cigarettes or drinking alcohol to cope, which can have detrimental effects on an unborn child. Health care providers can discuss healthier options, such as group or one-on-one therapy. In some cases, antidepressants may be recommended.

According to the Mayo Clinic, few medications have been proven safe beyond a doubt for use during pregnancy, which is why many doctors advise their patients who are pregnant or are considering pregnancy to wean off most drugs. However, some antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), should only be taken during pregnancy after a woman weighs the risks with her doctor because of the possibility of serious birth defects.

Common SSRIs that have previously been prescribed for depression during pregnancy include Celexa, Prozac, Zoloft and Paxil. However, with all those medications there is a possible risk of persistent pulmonary hypertension, or PPHN, in the newborn. The risk is so rare that Celexa, Prozac and Zoloft are still considered options for use during pregnancy.

However, in 2005, a scientific study indicated that women who took Paxil during the first three months of pregnancy had a greater risk of their unborn child developing birth defects – in particular heart defects – than any other antidepressant. As a result of that study, GlaxoSmithKline, makers of Paxil, updated the PRECAUTIONS section of its medication label discouraging use of Paxil during pregnancy.

The Mayo Clinic urges women to consult with their doctors and learn the risks and benefits of antidepressants during pregnancy before making a decision.

SOURCE: Paxil and Pregnancy › Mothers-to-be should weigh risks of antidepressants during pregnancy

According to Women’s Health, changing hormones throughout a woman’s life can trigger depression, including times such as puberty, during and after pregnancy, and during perimenopause. Some women also experience depressive symptoms right before their period. Women with a personal or family history of depression are more prone to suffer from postpartum depression.

It is identified by symptoms such as trouble sleeping, lack of interest, feelings of guilt, loss of energy, difficulty concentrating, changes in appetite, restlessness or slowed movement, and thoughts or ideas about suicide. It also can begin at any time within the first three months after delivery. And it can seriously threaten both the woman and her baby, which is why women who think they are experiencing postpartum depression, or individuals who are concerned about a loved one, should seek medical attention immediately.

Postpartum depression can be treated through support groups, counseling sessions with a mental health professionals and even antidepressants from a group of selective serotonin reuptake inhibitors (SSRIs). The most common ones are Zoloft, Paxil, Celexa and Prozac. A woman should discuss with her doctor if she plans to breastfeed while taking medication as many antidepressants can get into her breast milk and may cause problems for the baby.

She will want to discuss going off the medication before getting pregnant again, as some antidepressants, such as Paxil, have been linked to serious birth defects in babies whose mothers took the medication during pregnancy.

SOURCE: Paxil and Pregnancy › Postpartum depression puts mother, baby at risk

Christine K had been prescribed a combination of Paxil, Risperdal and Depakote five years prior to becoming pregnant. While pregnant she read that Paxil could be harmful to her unborn baby. She asked her doctor take her off the meds, but he insisted she stay on them.

Christine K did more research on the medications and learned that a scientific study on infants born to women taking antidepressants during the first trimester of pregnancy showed that women who took Paxil had a greater risk of birth defects compared to other antidepressants.

As a result of the study, in 2005, GlaxoSmithKline informed health care professionals that it was updating the precautions section of the label for its antidepressant Paxil to include the risk of birth defects and, in particular, heart defects.

In 2006, the Food and Drug Administration (FDA) released another Public Health Advisory based on another study that indicated additional risks associated with taking antidepressants during pregnancy including persistent pulmonary hypertention (PPHN), a serious and life-threatening lung condition that occurs soon after birth, omphalocele and craniosynostosis.

Six months into her pregnancy, against her doctor’s orders, Christine K heeded the warning signs she had read about online and weaned herself off Paxil and the other antidepressants. But the damage had already been done. While her son doesn’t have any of the above mentioned severe birth defects, he does experience sleep problems, aversions to eating, and overall poor health.

“In the first three years of his life, this child has needed more medical care and doctor’s appointments than my other three children combined,” she told the Dissident Voice. “All I can do is watch and wait and hope (his medical problems) resolve on their own.”

SOURCE: Paxil and Pregnancy › Child is helpless victim of mother’s use of Paxil during pregnancy

What Gibson soon realized was that a warning about heart defects in infants born to women who took Paxil during pregnancy was issued the very month her daughter was born.

“I never would have taken the (Paxil) had I been told,” Gibson told a reporter for The Province.

The long, red scar down the middle of her daughter’s chest is a painful reminder of the condition she was unnecessarily born with. She says her daughter’s heart defect has made the little girl prone to infections and stunted her growth.

In 2005, the FDA issued a warning to pregnant women and their doctors to stay away from Paxil because of the increased risk of heart defects in newborns. The agency fell short of banning the medication for pregnant women but stated that it “is advising patients that this drug should usually not be taken during pregnancy.”

The risk of heart defects among newborns is about 1 percent overall. For infants born to women taking Paxil, that number jumps to 1.5 to 2 percent, according to studies cited by the FDA.

SOURCE: Paxil and Pregnancy › Babies born to women taking Paxil at higher risk for heart defects

Numerous studies have not found an increased risk of major birth defects associated with the use of SSRIs during pregnancy. However, exposure to SSRIs late in pregnancy has been associated with short-term complications in newborns including jitteriness, mild respiratory distress, excessively rapid respiration, weak cry, poor muscle tone, and admission to the neonatal intensive care unit. Unpublished data regarding the use of Paxil® during the first trimester of pregnancy have raised concerns about an increased risk of congenital heart malformations. Thus, the US Food and Drug Administration issued a public health advisory regarding the use of Paxil® during pregnancy and the manufacturer changed its pregnancy category from C to D. A Category C classification is for drugs that have been shown to harm fetuses in animal studies but have not been adequately studied in humans. A Category D classification means a drug has been found to be harmful to human fetuses.

The potential risk of SSRIs during pregnancy must be weighed against the risk of depression relapse if the medication is discontinued. Untreated depression has its own risks, including low weight gain, alcohol and substance abuse, and sexually transmitted diseases, all of which have negative maternal and fetal health implications. Fetal echocardiography should be considered for women who were exposed to Paxil® in early pregnancy.

ACOG’s Committee on Obstetric Practice emphasizes that decisions about depression treatment should involve the obstetrician and the mental health clinician, along with the patient, ideally prior to pregnancy. However, because approximately 50% of pregnancies are unplanned, preconception planning for women with depression will not always be feasible, and treatment decisions about SSRIs will undoubtedly occur during pregnancy.

Committee Opinion #354, “Treatment with Selective Serotonin Reuptake Inhibitors During Pregnancy,” is published in the December 2006 issue of Obstetrics & Gynecology.

Source: The American College of Obstetricians and Gynecologists

SOURCE: Paxil and Pregnancy › ACOG Issues Opinion on SSRI Antidepressant Use During Pregnancy

ACOG’s Committee on Obstetric Practice “recommends that treatment with all SSRIs [selective serotonin reuptake inhibitors] or selective norepinephrine reuptake inhibitors or both during pregnancy be individualized and paroxetine [Paxil] use among pregnant women or women planning to become pregnant be avoided, if possible,” read the statement, which is in the December issue of Obstetrics & Gynecology.

The guidelines come a full year after the U.S. Food and Drug Administration(FDA) issued a warning about possible birth defects associated with Paxil when the drug is taken during the first trimester of pregnancy.

This warning was based on two studies. The first found about a 2 percent risk of heart defects in babies born to mothers who took Paxil early in their pregnancy, compared with a 1 percent risk in the general population.

The second study found that the risk of heart defects was 1.5 percent in babies whose mothers took Paxil in the first three months of pregnancy, compared with 1 percent in babies whose mothers took other antidepressants in the first trimester. The most common defects were cardiovascular.

“Since the FDA warnings a year ago, most ob/gyns have been trying to avoid Paxil during pregnancy,” noted Dr. Jennifer Wu, an obstetrician/gynecologist at Lenox Hill Hospital in New York City. “This is just a formal statement by ACOG.”

The initial FDA warning came in September of 2005. In December of the same year, the FDA instructed Paxil’s maker, GlaxoSmithKline, to reclassify the drug from a Category C to D (a stronger warning) for pregnant women. Category D means studies in pregnant women have demonstrated a risk to the fetus.

Other reports had indicated that SSRIs, the category of antidepressants which includes Paxil as well as Celexa, Prozac and Zoloft, may cause newborns to have withdrawal symptoms.

ACOG acknowledged that these potential problems must be weighed against yet another study which found that pregnant women who discontinue their antidepressant medication are five times more likely to relapse into depression than women who continue with the medication.

“Untreated depression has its own risks, including low weight gain, alcohol and substance abuse, and sexually transmitted diseases, all of which have negative maternal and fetal health implications,” the statement said.

Women of reproductive age have the highest prevalence of major depressive disorders, with ACOG experts estimating that about 1 in 10 will experience a bout of major or minor depression sometime during pregnancy or the postpartum period.

Ideally, these issues should be considered before a woman becomes pregnant, the ACOG panel said. But, given that about half of all pregnancies are not planned, many decisions regarding treatment will inevitably happen after the woman has conceived. Fetal echocardiography, which looks for heart trouble, should be considered for women who were exposed to Paxil in early pregnancy, the statement recommended.

“Women who have certain health problem such as depression really should try to plan their pregnancies with their ob/gyn and psychiatrist,” Wu confirmed. “The major danger will be to women who have an unplanned pregnancy and don’t realize it until they’re two months along. There’s a lot of organ development during that time, and exposure to certain SSRIs may pose some dangers.”

SOURCE: Health Day News

SOURCE: Paxil and Pregnancy › Ob/Gyn Group Urges Pregnant Women to Shun Paxil

The family sued the company in state court in Philadelphia for failing to warn consumers of the possible risks of taking the medication during pregnancy, according to the family’s attorney Karen Barth Menzies.

The family is seeking unspecified damages.

Source: Laywers USA

SOURCE: Paxil and Pregnancy › First Paxil birth defect lawsuit filed

The research raises troubling questions about the lack of safety data for many drugs prescribed to pregnant women.

About 8 percent of pregnant women develop high blood pressure, which can lead to a heart attack or stroke.

Exactly how many pregnant women take ACE inhibitors or another blood pressure medication is unclear. However, a national survey found the number of ACE inhibitor prescriptions given to women of childbearing age increased from 1.4 million in 1995 to 2.7 million in 2002, the latest data available.

ACE inhibitors already carry a strong Food and Drug Administration “black box” warning about their dangers in the later stages of pregnancy, and the label says the drugs should be discontinued when pregnancy is detected. But little has been known about their early effects.

Avoid use during pregnancy

Based on the new findings, taking these drugs during early pregnancy “cannot be considered safe and should be avoided,” lead researcher Dr. William Cooper, a Vanderbilt University pediatrician, said in Thursday’s New England Journal of Medicine.

The FDA said more research is needed before it considers changing the warning label to specifically include the risks during the first trimester. But the agency is notifying doctors and patients about the dangers through its Web site.

Doctors said expectant mothers should not stop treatment, because uncontrolled high blood pressure can harm them and the fetus, but should immediately switch to other drugs. Women contemplating pregnancy were advised to ask their doctors about their options.

‘Wake-up call’

“This is a wake-up call. We need to learn more about these drugs to offer better advice to pregnant women,” said Dr. J.M. Friedman, a medical geneticist at the University of British Columbia who had no role in the study.

ACE inhibitors have been on the market for 25 years, but little research has been done on their effects during early pregnancy with the exception of animal experiments and small human studies. The drugs work by relaxing blood vessels and increasing blood flow to the heart.

Last year, U.S. sales of ACE inhibitors topped $3.8 billion, with about 150 million prescriptions filled, according to IMS Health, a pharmaceutical information company. The top-sellers include Lotrel, Altace and Lisinopril.

In the study, researchers studied Medicaid records on 29,507 Tennessee infants born between 1985 and 2000. Of those, 411 had mothers who took a blood pressure drug at least once during their first trimester, including 209 who took ACE inhibitors.

About 7 percent of babies exposed to ACE inhibitors developed major birth defects compared with about 2 percent whose mothers took no drugs or other blood pressure medication, such as water pills, calcium channel blockers or beta blockers.

The most common defects included holes in the heart and neurological and kidney problems.

Researchers found no increased risk among babies whose mothers took another type of blood pressure medication. But they said it is premature to declare those drugs safe to use during early pregnancy.

Finding points to larger problem

“It’s a sobering finding,” said Dr. Robyn Barst, a pediatric cardiologist at Columbia University and spokeswoman for the American Heart Association. “It highlights our lack of data on many drugs that we think are perfectly safe.”

The study was partly funded by the FDA. Three co-authors reported receiving support or fees from Novartis AG or Pfizer Inc. Novartis makes Lotrel. Pfizer makes the calcium blocker Norvasc.

In an accompanying editorial, Friedman of the University of British Columbia said the ACE inhibitor study points to a larger problem about the lack of safety data available on most new drugs when they receive government approval.

The FDA acknowledged it was an imperfect system. Dr. Robert Temple, the agency’s associate director for medical policy, said the government is trying to improve its detection of harmful effects through patient registries and other studies.

“The only way to discover (risks) is through long-term use. That’s a little uncomfortable. It means you only learn about what drugs do to pregnancies after the drug’s been used for a long time,” Temple said.

In the early 1990s, the FDA required pharmaceutical companies to put warning stickers on ACE inhibitors after the agency received a few reports from women whose babies were harmed. The label warned that ACE inhibitors can cause skull deformities, kidney failure, lung problems and even fetal death when taken in the last two-thirds of pregnancy.

Source: AP

SOURCE: Paxil and Pregnancy › Blood pressure pill doubles risk of birth defects

The lawsuit, filed in Pennsylvania state court, is seeking unspecified damages for failing to warn pregnant women about the risks of taking Paxil.

During the last month of her pregnancy, Vasquez learned, while receiving an ultrasound to determine the sex of her baby, that there was something wrong with his heart.

Since then, Adrian has undergone three open-heart surgeries and now has a pacemaker.

The seriousness of these birth defects is such that, at the very first sign of danger, GSK should have issued a strong warning, said attorney Karen Barth Menzies, who is representing the family.

Adrian will need repeated heart surgeries as he continues to grow and may need artificial replacement valves, and perhaps eventually a heart transplant. His prognosis is unclear, she said.

Menzies added that with 40,000 pregnant women nationwide taking antidepressants, thousands of babies are at risk.

Source: Lawyers USA

SOURCE: Paxil and Pregnancy › Paxil Maker Sued Over Child Born with Severe Birth Defects

A second study suggests there may be additional, though rare, risks of SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk in one drug compared to another, and this risk has not so far been investigated by other researchers. The study, by Christina Chambers and others, was published on February 9, 2006 in The New England Journal of Medicine.

The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns coming from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing. In addition, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiology study suggesting that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects (see FDA Public Health Advisory for Paxil dated December 8, 2005).

The uncommon potential risk to the newborn of PPHN has not been confirmed by additional studies. Uncertainty about these rare events and their potential impact on the newborn, along with the potential risk to the mother of recurring depression if she stops her antidepressant medicines during pregnancy, makes decisions about the treatment of depression in pregnant women especially challenging for health care professionals and patients.

Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant without first consulting their physician. The decision to continue medication or not should be made only after there has been careful consideration of the potential benefits and risks of the medication for each individual pregnant patient. If the decision is made to stop treatment with SSRIs before or during pregnancy, this should be done with a healthcare professional, according to the prescribing information for the drug, and patients should be observed closely in case their depression comes back.

The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. In the meantime, the FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN. Prescribing information will be updated with information from additional studies when this information becomes available.

SSRIs and a Combination Drug Containing an SSRI

• Celexa (citalopram)
• Fluvoxamine
• Lexapro (escitalopram)
• Paxil (paroxetine)
• Prozac (fluoxetine)
• Symbyax (olanzapine/fluoxetine)
• Zoloft (sertraline)

Source: FDA Public Health Advisory

SOURCE: Paxil and Pregnancy › Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns

Results of two early studies reviewed by the FDA showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect compared with women who took other antidepressants or women in the general population. Most of the heart defects reported in these studies were of the type known as atrial and ventricular septal defects (holes in the walls of the chambers of the heart). These types of heart defects can range in severity from relatively minor that resolve without treatment to those that cause serious symptoms and need to be repaired surgically. The risk for this type of heart defect is approximately one per cent of births in the general population. In one of the studies with Paxil, women taking the drug had an approximately two per cent risk of having a baby with heart defects, and in the second study, women taking Paxil in the first trimester had an approximate 1.5% risk of having a baby with heart defects.

According to the FDA announcement:

FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy. Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients. In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. FDA is advising health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate.

The manufacturer of Paxil, Glaxo Smith Kline, has changed the product labeling from pregnancy class C to class D, meaning that that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy with Paxil may outweigh the potential risks to the fetus.

It’s important to note that these conclusions are preliminary and are based on early results of two studies. The FDA is collecting additional data and waiting for the final results of these and other studies in order to better characterize and understand the risk for birth defects associated with Paxil. If you’re currently taking Paxil, talk to your doctor if you are pregnant or planning to become pregnant. He or she can advise you on the best course of action for your situation and medical condition

Source: MedicineNet

SOURCE: Paxil and Pregnancy › Updated Product Labeling Warns of Birth Defect

FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus.  Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy.  Women taking Paxil should not stop taking it without first talking with their physician.

The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.

In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.

FDA has asked the manufacturer, Glaxo Smith Kline (GSK), to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus.

Based on results of the preliminary data, GSK updated the drug’s labeling in September 2005 to add data from one study. As additional data have become available, the label has now been changed to reflect the latest data from the two studies and to change the pregnancy category.

Source: FDA

SOURCE: Paxil and Pregnancy › FDA Advising of Risk of Birth Defects with Paxil

The company cited newly analyzed data from a retrospective epidemiologic study of major congenital malformations in infants, saying that “preliminary results suggest an increase in the risk of congenital malformations associated with the use of paroxetine as compared to other antidepressants.”

Changes in the drug’s labeling are being made after consultation with the U.S. Food and Drug Administration (FDA).

Current FDA-approved labeling lists paroxetine as a pregnancy Category C drug. Category C is defined as drugs with “no adequate and well-controlled studies in humans to determine the effect on the fetus.” Current labeling reminds prescribers that paroxetine during pregnancy should be used only if the potential benefit justifies the potential risk.

Information will be added to the product label indicating that of 3,581 pregnant women exposed to paroxetine or other antidepressants during the first trimester, use of paroxetine, compared with other antidepressants, was associated with an “increased risk of overall major congenital malformations.”

Specifically, women who took paroxetine were 2.2 times more likely to give birth to an infant with a major congenital malformation and 2.08 times more likely to give birth to an infant with a cardiovascular malformation than women on other antidepressants. Of 14 infants with a major congenital malformation born to women taking paroxetine, 10 of those with cardiovascular malformations had ventricular septal defects.

The new labeling goes on to note that a separate study based on the Swedish Medical Birth Registry “evaluated 4,291 infants exposed to SSRIs in early pregnancy. This study reported no increased risk for overall major malformations in 708 infants born to women with paroxetine exposure early in pregnancy.”

In the company’s “Dear Healthcare Provider” letter regarding the new labeling, GSK said that “it is important to note that because the GSK study was designed to evaluate the relative risk of congenital malformations in infants born to women exposed to antidepressants, the study did not include a comparison to infants who were not exposed to any antidepressant. Therefore, these data should be viewed within the context of the overall prevalence of congenital malformations in the general population, which is estimated in the U.S. to be approximately 3 percent for any malformation, and approximately 1 percent for cardiovascular malformations alone.”

GSK reviewed other epidemiological studies of SSRI exposure during pregnancy in its “Dear Healthcare Provider” letter, as well as several case-control studies. In addition, it cited the National Birth Defects Prevention Study of infants delivered from 1997 through 2001.

In that study, women who took any SSRI were more likely than those who were not exposed to have an infant with omphalocele.

The strongest effect was reported in that study to be with paroxetine, which accounted for 36 percent of all exposures to an SSRI. Infants born to mothers taking paroxetine during the first trimester were found to be 6.3 times more likely to have an omphalocele compared with infants born to mothers who took no SSRIs. An association was also found between SSRI exposure and infants being born with craniosynostosis.

GSK concluded, “The differences in the results from the available studies and the diversity in type of abnormalities recently reported makes it difficult to definitively conclude a causal relationship for any particular congenital abnormality with paroxetine.”

The company, in cooperation with FDA requests, is conducting additional epidemiologic studies “to more fully understand these preliminary findings.”

SOURCE: Paxil and Pregnancy › New Paxil Labeling Warns Of Birth-Defect Risk

Paxil Linked to Twice as Many Birth Defects

GlaxoSmithKline recently conducted a study of major birth defects in infants born to women who took antidepressants (including Paxil) during the first trimester of pregnancy.

In a study of more than 3,500 pregnant women, Paxil was linked to twice as many major birth defects as other antidepressants, according to the FDA.

Birth defects are very rare in the U.S., and it’s not certain what role, if any, Paxil played in the birth defects seen in the study, notes GlaxoSmithKline.

Changes have been made to the labeling information on pregnancy precautions that accompanies Paxil, says the FDA.

GlaxoSmithKline is a WebMD sponsor.

Most of the birth defects seen in the study were heart related; the most common heart malformations were ventricular septal defects, which are holes between the heart’s two main pumping chambers. These are common birth defects overall as well.

The study was a retrospective epidemiological study. That means it looked at large groups of people in hindsight. There was no data on birth defects in babies born to women who didn’t take antidepressants during early pregnancy.

From the Company to Doctors

It is “difficult” to determine whether Paxil caused those birth defects, says GlaxoSmithKline in a letter sent to doctors.

In the letter, the company notes that these findings differ from previous studies looking at birth defects and antidepressants.

Data from the large Swedish Medical Birth Registry hasn’t shown evidence of increased risk of major birth defects with antidepressants, including Paxil, notes GlaxoSmithKline.

GlaxoSmithKline spokespeople were not immediately available for comment.

Paxil’s Warning

Paxil’s official web site puts it this way:

“Tell your doctor if you are pregnant or plan to become pregnant as there is a potential risk to the fetus with [Paxil]. Some studies of [Paxil] in pregnant women have suggested a possible increased risk of malformations, while others have not shown such a risk.”

Antidepressants, including Paxil and others, such as Prozac and Zoloft, have been linked to withdrawal symptoms in babies born to mothers taking these medications. These antidepressants are known as selective serotonin reuptake inhibitors (SSRIs).

The Paxil web site also says: “Babies born to mothers who have taken antidepressants, including SSRIs such as Paxil, in the third trimester of pregnancy have reported complications, including difficulties with breathing, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, floppiness, stiffness, tremor, shakiness, irritability or constant crying. Tube feeding, help with breathing and longer hospitalization may be needed. There have also been reports of premature births in pregnant women exposed to SSRIs, including Paxil.

“Like many antidepressants, Paxil can be present in breast milk so tell your doctor if you are nursing.”

Source: WebMD Health News

SOURCE: Paxil and Pregnancy › New Study Links Paxil to Twice as Many Birth Defects as Other Antidepressants