FACT SHEET
General information:
In 2003, GSK initiated a retrospective analysis of women, dating back to 1995, who had taken antidepressants in the first trimester of their pregnancies and had given birth to children with major congenital malformations. The study found an association between Paxil and congenital malformations in mothers taking Paxil in the first trimester.
Another study conducted by researchers in Denmark and published in Pharmacoepidemology and Drug Safety in 2005 showed a more than 2-fold increase for congenital malformations in women taking Paxil compared to other antidepressants.
In September 2005, GSK sent out a "Dear Doctor" letter informing physicians throughout the United States that the results of its analysis showed a higher rate of "congenital malformations associated with the use of Paxil as compared to other antidepressants" in infants born to women taking antidepressants during the first trimester of pregnancy. The most common malformations for mothers taking Paxil were cardiovascular, particularly ventricular septal defects ("VSD").
The FDA has issued three Public Health Advisories since December 2005 concerning the risk of congenital heart defects and has changed Paxil’s pregnancy category from C to D, which indicates that "[t]here is positive evidence of fetal risk."
"The American Medical Association estimates that over 1 percent of pregnant women in the US, or more than 40,000, are taking antidepressants." Armstrong, Wall St. Journal
Sales of antidepressants in the US last year exceeded $12.5 billion. Armstrong, Wall St. Journal
Paxil crosses the placenta, which could have important implications for the developing fetus.
Serotonin (the neurotransmitter that Paxil primarily affects) plays a roll in the fetal development of the heart.
FDA Public Health Advisories Concerning Paxil Birth Defects:
According to an FDA Public Health Advisory dated December 2005
http://www.fda.gov/cder/drug/advisory/paroxetine200512.htm:
A study using a Swedish national registry found a 2-fold increased risk of having an infant with a cardiac defect compared to the entire national registry population.
In another study in the US, women who received Paxil in the first trimester of their pregnancies had a 1.5-fold increased risk of cardiac malformations.
In March/April 2006 http://www.fda.gov/fdac/departs/2006/206_upd.html#paxil, the FDA updated its data on Paxil and the Risk of Birth Defects, explaining that early results of two studies "indicate 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 holes in the walls of the chambers of the heart (atrial and ventricular septal defects)." The FDA advised "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."
On July 19, 2006 http://www.fda.gov/cder/drug/advisory/SSRI_PPHN200607.htm, the FDA issued another Public Health Advisory titled "Treatment Challenges of Depression in Pregnancy." Ironically, the FDA cites a study that warns of depression relapse in women who decide to stop taking their antidepressant, which study has received a great deal of criticism and was the topic of a front-page Wall Street Journal article exposing the fact that most of the authors of the study had undisclosed financial ties to antidepressant manufacturers. http://www.paxilbirthdefect.com/news.shtml Notwithstanding, the new advisory warns of the recent study by Christina Chambers concerning the risk of pulmonary hypertension in babies born to mothers who took antidepressants in their third trimester of pregnancy.
Paxil label re Pregnancy:
In 2003, the prescribing information for Paxil stated:
"Pregnancy: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy."
The label also described GSK’s animal studies as having "revealed no evidence of teratogenic effects." ("Teratogen" means any substance with the potential to cause birth defects.) Paxil was identified as a Category C drug (Category C drugs are those in which: "Either animal studies indicate a fetal risk and there are no controlled studies in women, or there are no available studies in women or animals.) The label also stated: "There are no adequate and well-controlled studies in pregnant women." The label further states that Paxil "should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."
The FDA has changed Paxil’s pregnancy category from C to D (Category D: "There is positive evidence of fetal risk, but there may be certain situations where the benefit might outweigh the risk [life-threatening or serious diseases where other drugs are ineffective or carry a greater risk].)
Other Complications of Taking Paxil During Pregnancy:
A study published in Teratology Society Abstracts in 2005 reported that women who took Paxil were more likely than those who were not exposed to have an infant with omphalocele (a fetal malformation in which variable amounts of abdominal contents protrude into the base of the umbilical cord) and craniosynostosis (the early closing of one or more of the sutures of an infant’s head, resulting in malformation of the skull). The strongest effect was reported to be with Paxil.
A recent study published in the New England Journal of Medicine (NEJM) by Christina Chambers of the University of California, San Diego, found a six-fold increased risk of persistent pulmonary hypertension (PPH) in infants born to mothers who took an antidepressant in the last trimester of pregnancy.
How Effective are Antidepressants?
There is a general consensus that doctors must weigh the benefits of drug treatment versus the risks. In order to do a proper risk benefit analysis, a doctor must be aware of the degree of effectiveness of the drug – not just drug company hype. Is the drug extremely effective or only marginally effective? Doctors know the drug was approved by the FDA, but do they know the FDA’s standards for approving a drug as effective?
In an analysis of efficacy data submitted to the FDA between 1987 and 1999 for six of the most popular selective serotonin reuptake inhibitor (SSRI) antidepressants, including Paxil, 75 to 80% of the response to medication was duplicated in placebo groups.1 These data were the basis on which the medications were approved by the FDA. The researchers explained that the "small difference between the drug response and the placebo response has been a ‘dirty little secret’ known to researchers who conduct clinical trials, FDA reviewers, and a small group of critics who analyzed the published data …"2 Yet another recent meta-analysis found that SSRIs have "no clinically meaningful advantage over placebo."3
FDA approval of these drugs implies that the data were strong enough and reliable enough to warrant approval, however, as one FDA memo illustrates, the FDA’s standards for approving antidepressants as effective are not robust: "Approval [of the antidepressant] may … come under attack by constituencies that do not believe the agency is as demanding as it ought to be in regard to its standards for establishing the efficacy of antidepressant drug products."
Complicating the risk/benefit analysis further is industry-exaggerated prevalence of illness. Is the mother really suffering from clinical depression or has pharmaceutical marketing done such a tremendous job at "selling sickness" that a pregnant woman who is feeling "down in the dumps" is immediately prescribed a drug that could cause very serious harm to her unborn child.
http://bmj.bmjjournals.com/cgi/content/full/324/7342/886
Baum Hedlund has the longest track-record handling SSRI antidepressant litigation, having litigated over 3,000 antidepressant cases in the past 17 years. The firm has five plaintiff attorneys specifically dedicated to litigating the SSRI antidepressant cases.
Since 1990 Baum Hedlund has been handling antidepressant-SSRI (selective serotonin reuptake inhibitors) cases and served on the Plaintiffs' Steering Committee in the early 1990s in the first SSRI-suicide litigation involving Prozac (the first SSRI approved by the FDA for marketing in the U.S.).
Baum Hedlund also represents dozens of antidepressant suicide and suicide attempt victims across the country. They have handled SSRI-induced suicide / violence litigation involving Prozac, Paxil and Zoloft.
For more than a decade Baum Hedlund partner, Karen Barth Menzies has been handling SSRI-antidepressant cases. She is Lead Counsel and a member of the Plaintiffs' Steering Committee in charge of the multi-district litigation re Paxil Products Liability Litigation. She led the legal team which successfully defeated Pfizer's (maker of Zoloft) and the FDA's preemption arguments in a number of cases.
In addition to her court activities Ms. Menzies has testified about the dangers of SSRIs before the FDA’s Psychopharmacologic Drugs Advisory Committee (and is schedule to speak again on Dec. 13, 2006 before the same committee about the suicide risk of antidepressants in adults) and the California State Senate. She met with members of the House and Senate regarding the risk of antidepressant-induced suicidality and assisted in a congressional investigation regarding same. In 2004 Karen was named Lawyer of the Year by Lawyer’s Weekly USA, California Lawyer of the Year by California Lawyer magazine and in 2005, one of The National Law Journal’s Top 40 Under 40 for her "extraordinary achievements" and "stepping up her fight in the past few years, advocating that pharmaceutical companies should warn about the alleged risks of antidepressant drugs."
1. Kirsch and Moore, "The Emperor’s New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration," Prevention & Treatment, Volume 5, Article 23, July 15, 2002.
2. Moncrieff and Kirsch, "Efficacy of antidepressants in adults" BMJ July 2005.
3. Kirsch, Moore et al., "Antidepressants and Placebos: Secrets, Revelations, and Unanswered Questions," Prevention & Treatment, Volume 5, Article 33, posted July 15, 2002.
