antidepressant Paxil Might Be Associated With Birth Defects, Study Says
GlaxoSmithKline’s antidepressant drug Paxil might be associated with birth defects, FDA said on Tuesday, the AP/Philadelphia Inquirer reports. According to FDA and the company, a retrospective study on women who took Paxil during the first trimester of pregnancy found that there were an increased number of infants born with birth defects, including heart defects, when compared with pregnant women who took other antidepressants during their first trimester. The medication is classified as a “Category C” drug for pregnant women, which means comprehensive studies of its effects during pregnancy have not been performed. GSK advised physicians “to carefully weigh the potential risks and benefits of using [Paxil] therapy in women during pregnancy,” adding, “It is recommended that health care providers discuss these latest findings, … as well as treatment alternatives, with their patients.” The company said it has not decided whether a definitive causal link exists between the drug and an increased incidence of birth defects. The company cited a separate study of births that showed no comparable increase (AP/Philadelphia Inquirer, 9/28). However, GSK said it plans to include the findings of the study in the drug’s list of precautions (USA Today, 9/28).