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 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?

The FDA has been conducting an investigation into studies that suggest using selective serotonin reuptake inhibitors (SSRIs) during pregnancy increases the risk of persistent pulmonary hypertension (PPHN) in newborns. The agency said that when grouped with other studies, the results were conflicting and thus it is premature for the FDA to make any formal conclusions about the risk.

SSRIs are one of the most commonly prescribed medications in the United States. They are prescribed to treat depression and other psychiatric disorders. SSRIs are marketed under various brand and generic drug names Including Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); and Viibryd (vilazodone).

The FDA already has notified health care professionals and the public on the use of SSRIs by women during pregnancy and the potential risk of the rare heart and lung condition. The initial Public Health Advisory issued in July 2006 on this potential risk was based on a single published study. Since then, the FDA says there have been conflicting findings from newer studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.

PPHN occurs when a newborn baby does not adapt to breathing outside the womb. Newborns with the condition may require intensive care support including a mechanical ventilator to increase their oxygen level. If severe, PPHN can result in multiple organ damage, including brain damage and even death.

The FDA is advising doctors not to alter their current clinical practice of treating depression during pregnancy. However, any serious side effects with SSRIs should be reported to the FDA at www.FDA.gov/MedWatch/Report.htm.

Source: FDA

SOURCE: Paxil and Pregnancy › FDA won’t issue stronger warnings on SSRI use during pregnancy

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

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

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

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

Researchers have found that when the test is used on newborns it can identify 75 percent of the most serious cardiac abnormalities. When used with traditional methods, 92 percent of the cases were detected.

Congenital heart defects are the No. 1 birth defect, with more than 25,000 cases reported in the United States each year. Some are so mild that there are no outward symptoms, like murmurs which resolve on their own. But in some cases, the defect is so serious that newborns become ill soon after birth. In still other cases, signs and symptoms occur only later in childhood. Severe heart defects often require multiple surgeries, a lifetime of medications and preventative measures to maintain a working heart and healthy body. For some, the only hope is a heart transplant.

Congenital heart defects are typically detected by ultrasound during pregnancy or by listening to the baby’s heart after birth. However, with this type of screening, many heart problems go undetected, which can put the baby’s life at risk.

Scientists don’t always know what causes hearts to develop abnormally. Genetics and the environment play a strong role, as can medications taken by the mother during pregnancy. Medications that have been linked to heart defects in infants include Accutane (for acne), lithium (for some forms of mental illness,) and some anti-seizure drugs. Recently, researchers have raised concerns about certain SSRI medications used to treat depression and anxiety. Studies have linked certain heart defects to SSRI such as Prozac and Paxil. And new reports show that Zoloft may be just as dangerous.

Source: BBC

SOURCE: Paxil and Pregnancy › New screening for newborns could detect heart defects faster

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

All selective serotonin reuptake inhibitors, or SSRIs, except for paroxetine, or Paxil, are categorized as Class C. These drugs include citalopram, sold as Celexa; fluoxetine, sold under the brand Prozac; fluvoxamine, known as Luvox; sertaline, or Zoloft; and escitalopram, sold as Lexapro. Paxil was recently switched from a Category C to a Category D drug.

Class C drugs show harm to fetuses in animal studies, but there are no adequate controlled human studies to confirm or deny this harm to fetuses to human. These medications are considered OK to be prescribed to pregnant women if they need the medications.

Category D drugs, like Paxil, are more toxic. With these drugs, there is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

But studies on all SSRIs suggest that other antidepressants in the class, such as Zoloft, may be just as dangerous to unborn children as Paxil. In June 2007, studies found an association between use of SSRIs in early pregnancy and a risk of abnormal skull development, gastrointestinal abnormality, and brain defects. In September 2009, a study published in the British Medical Journal found that SSRI antidepressants increase the risk of heart defects when taken during the first trimester.

Since antidepressants serve an important purpose for women who suffer from depression, the FDA advises women who are pregnant or thinking about becoming pregnant not to stop taking their antidepressant without first consulting their physician. The decision to continue medication or not should be made after both risks and benefits of the medication are weighed.

Sources:
Safe Fetus
Consumer Affairs

SOURCE: Paxil and Pregnancy › Women should consider SSRI risks to fetuses

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

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

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

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

The families contend that the mothers’ use of Paxil during pregnancy resulted in severe heart defects in their infants and have sued GlaxoSmithKline for failure to warn the public about the dangers of the drug for pregnant women.

The American College of Obstetricians and Gynecologists recently recommended that pregnant women not use Paxil, according to the plaintiffs’ lawyer, Karen Barth Menzies of Los Angeles.

Two of the plaintiffs are from West Virginia, two from Ohio and one from Nebraska.

Source: Lawyers USA

SOURCE: Paxil and Pregnancy › Parents sue Paxil maker 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 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

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 extent of the heart defects ranged from mild to those that were severe enough to require surgery.

The FDA said that based on the data, it is asking that Paxil’s drug classification be changed from “C” to “D”. Doctors use the classification system to decide whether or not to prescribe a specific drug to a woman who is pregnant.

Despite the warning, the FDA said that Paxil’s benefits may outweigh its risks for certain patients. Paxil is also known by the generic name paroxetine.

The FDA noted that Glaxo (GSK ) had changed its label in September to reflect results from one of the clinical studies. The agency said it now asked the company to update Paxil’s label to now include results from the second study.

In September, Glaxo also sent out letters to health professionals advising of the labeling changes for pregnant women, according to the FDA’s website.

Like many other popular antidepressants, Paxil also carries a warning advising that it can trigger suicidal thoughts in some children and adolescents. The drug is not approved for pediatric use.

Paxil was first approved by the FDA in December 1992.

Source: MarketWatch

SOURCE: Paxil and Pregnancy › FDA strengthens pregnancy warning on Glaxo’s Paxil