The FDA has issued a warning about paroxetine (Paxil) following the early results of new studies showing that the drug increases the risk of birth defects, especially heart defects, when women take it during the first 3 months of pregnancy. For some women who have already been taking paroxetine, however, the benefits of continuing paroxetine may be greater than the potential risk to the baby. Women taking paroxetine who are pregnant, think they are pregnant, or plan to become pregnant should talk to their healthcare provider about the potential risks of taking paroxetine during pregnancy.
The women in the studies who took paroxetine during the first trimester were about 1.5 to 2 times as likely to have a baby with a heart defect as women who received other antidepressants and women in the general population. The agency has asked GlaxoSmithKline to change the Pregnancy Category from C to D.