Early results of new studies suggest GlaxoSmithKline Plc’s antidepressant Paxil increases the risk of birth defects when women take it during the first three months of pregnancy, the Food and Drug Administration said Thursday.
“FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus,” the FDA said in a statement.
Preliminary findings from two studies showed women who took Paxil during the first three months of pregnancy were about 1.5 to 2 times as likely to have a baby with a heart defect as women who took other antidepressants, or women in the general population, the FDA said.
GlaxoSmithKline added data from one of the studies to Paxil’s prescribing information in September and since then has added details from the second study, the FDA said.
