The U.S. Food and Drug Administration (FDA) warned in 2005 that early research studies of Paxil (paroxetine) suggest if an expectant mother takes the dangerous drug during the first trimester of her pregnancy, it may increase the baby’s risk of being born with defects, particularly heart defects. Prior to this FDA warning, antidepressants, specifically selective serotonin reuptake inhibitors (SSRIs) like Paxil, were thought to be mostly safe for pregnant women. However, as Jennifer Berg learned, that’s not the case.
Jennifer Berg filed a lawsuit against GlaxoSmithKline (GSK) in 2007 related to the 2004 death of her baby from a heart condition, which she believed was the result of her having taken Paxil during her pregnancy. The lawsuit alleged that at the time Paxil was prescribed to Berg, GSK “knew or should have known” about the risks associated with taking Paxil during pregnancy, based on “pre-market studies and post-market studies and reports that Paxil was associated with an increased risk of PPHN (persistent pulmonary hypertension of the newborn).” But when Berg was prescribed Paxil, the drug’s labeling still categorized it as a pregnancy Category C medication, meaning animal studies had shown adverse effects on fetuses, but there were no adequate and well-controlled human studies showing the same. Paxil settled with Berg for an undisclosed amount. In another Paxil pregnancy case, a Philadelphia jury awarded $2.5 million to a woman who filed suit against GSK after her son was born in 2005 with heart defects. Women who believe they may have cause for a Paxil pregnancy lawsuit can discuss their case with a qualified drug attorney.
The FDA did not issue a drug recall after discovering the risks of taking Paxil during pregnancy, and although most healthcare providers avoid prescribing the drug to pregnant women, it is still prescribed to some. Although Paxil did not become a recalled drug, the FDA did classify it as a pregnancy Category D medication. This categorization means positive evidence exists concerning human fetal risk, but the FDA believes the benefits from use in pregnant women may be acceptable despite the risks. Accordingly, a healthcare provider may prescribe Paxil to a pregnant woman if he or she believes the benefits to the woman outweigh the possible risks to her fetus.
Women who took Paxil during their pregnancy and whose babies show symptoms of birth defects, PPHN or heart problems, such as atrial and ventricular septal defects, can contact our firm to learn about their legal rights from an experienced drug lawyer.