Paxil Birth Defects

The FDA released a public health advisory in December of 2005 revealing that women taking Paxil (generic: paroxetine) during the first trimester of pregnancy may have an increased risk of delivering a child with cardiac birth defects. The agency also announced that, due to the potential risk of Paxil birth defects, the drug would be moved to pregnancy category D, indicating that human research suggests that the drug poses a risk to a fetus. These decisions were based on the agency’s analysis of two studies, which revealed that most of the observed Paxil cardiac defects were atrial septal defects or ventricular septal defects.

While the FDA has associated Paxil use during pregnancy with holes in the heart, studies have linked the use of SSRI drugs, a class of antidepressants which includes Paxil, during pregnancy to a number of other cardiac malformations including:

• Hypoplastic left heart syndrome
• Tetralogy of fallot
• Coarctation of the aorta
• Omphalocele
• Club foot
• Craniosynostosis
• Spina bifidia

Morgan & Morgan attorneys are no longer taking claims for this class action case.