The newest class of anti-depressant drugs is called selective serotonin reuptake inhibitors (SSRIs) and marketed under various brand and generic drug names such as Prozac, Zoloft, Paxil, Lexapro and Depakote. These medications are among the best-selling drugs in the world. Millions of people who suffer from depression and other psychiatric disorders use these drugs and statistics show that the majority of these patients are women.
Despite this fact, according to the U.S. Food and Drug Administration, there are no adequate and well-controlled studies about SSRIs and pregnant women. This appears to be a startling and disturbing fact given the fact that many women’s depression increases during the stress of pregnancy and that a long list of birth defects in infants born to women who used SSRIs during their pregnancies has been linked to SSRI side effects.
There are huge numbers of SSRI birth defect lawsuits that have been filed against the manufacturers of these drugs. Many of them are being consolidated before a federal judge and additional, similar lawsuits are being filed as more birth defects are being reported. Read more on the possible Zoloft Class Action Lawsuits
Typical of these lawsuits was one recently filed by SSRI birth defect lawyers on behalf of a Nevada woman who is alleging that her child’s birth defects were caused by her use of the anti-depressant Zoloft, manufactured by pharmaceutical giant Pfizer. The woman alleges in her lawsuit that because she took Zoloft while pregnant her child was born with “multiple congenital cardiac birth defects, including but not limited to ventricle septal defect, craniosynostenosis and scaphoid cephalic head shape with premature fusion of the sagittal.”
As with the other lawsuits filed against SSRI manufacturers, the woman’s lawyers are claiming that Pfizer should be found negligent in its responsibilities to adequately warn patients and government regulators of dangerous side effects because the company “knew or should have known” about the possibility of infants of these mothers developing birth defects.
There have been calls for the recall of SSRIs but the FDA has not taken such action. The agency did, however, recently issue an updated warning to health care professionals and the public about the use of selective serotonin reuptake inhibitor antidepressants by women during pregnancy and the potential risk of a serious, life-threatening heart and lung condition known as Persistent Pulmonary Hypertension of the Newborn (PPHN).
The FDA said an initial Public Health Advisory issued in July 2006 on this potential risk was based on a single published study. Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN, according to FDA officials.