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 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.”
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
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 2006, 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.”
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].)
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.
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.
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 …” Yet another recent meta-analysis found that SSRIs have “no clinically meaningful advantage over placebo.”
If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Fort Worth Texas Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.
The Dr. Shezad Malik Law is currently evaluating and accepting Paxil Birth Defect cases.