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

The study, recently published in the British Medical Journal, looked at the rate of persistent pulmonary hypertension, or PPHN, in babies born to women who took selective serotonin reuptake inhibitors, or SSRIs, during pregnancy. PPHN is a condition with high blood pressure in the lungs that leads to difficulties in breathing and can increase the risk for heart failure.

Normally, only one in three infants per 1,000 develop PPHN. However, researchers found a much more significant risk in women who took SSRIs during pregnancy, especially late in the fetus’ development. SSRIs include the brand names Paxil, Zoloft, Celexa, Lexapro and Prozac.

Researchers studied data that included 1.6 million births (33 weeks gestation or greater) in five Nordic countries between 1996 and 2007. A total of 1,618,255 singleton births were included in the study. Approximately 11,000 of the mothers filled prescriptions for antidepressants late in pregnancy, and about 17,000 of the mothers filled prescriptions for antidepressants in early pregnancy.

Researchers noted that out of 11,014 mothers who used SSRIs late in pregnancy, 33 babies were born with PPHN. Among the 17,053 mothers who used SSRIs during early pregnancy, 32 were born with SSRIs.

Attorneys with Beasley Allen Law Firm are currently investigating cases of birth defects of all kinds in children whose mothers took SSRIs during pregnancy.

Source: Psych Central

SOURCE: Paxil and Pregnancy › SSRI exposure late in pregnancy increases risk for PPHN

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

Newer studies suggest that there is no increased risk of suicide, and others show that the risk of suicide attempts in adults who start taking SSRIs is actually reduced, particularly in men and especially with sertraline, known by the brand name Zoloft. These findings are published in a recent issue of the journal Lancet.

This is good news to the millions of people who suffer from depression. But researchers are quick to warn that there are serious safety risks with the drugs, especially when they are used by women during pregnancy.

Paroxetine, known by the brand name Paxil, has been proven to increase the risk of major fetal malformations, especially cardiac defects. SSRI use during late pregnancy has also been linked to persistent pulmonary hypertension in newborns. And, continuous exposure to SSRIs throughout pregnancy can increase the risk of preterm birth compared with babies who had little or no SSRI exposure in utero.

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

Researchers conclude that SSRIs serve a purpose in treating depression but should be used with caution during pregnancy and advise that Paxil be avoided all together.

Source: Medscape

SOURCE: Paxil and Pregnancy › SSRIs still considered risky during pregnancy

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

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

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

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

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

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

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

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