Paroxetine use in pregnancy and increased risk of heart defects: Evaluating the evidence.

QUESTION: I have a patient who has just found out she is pregnant, and she is currently taking paroxetine for severe anxiety and depression. Owing to conflicting results from different studies, as well as my patient hearing about the lawsuit against GlaxoSmithKline, I did try her on other antidepressants; however, only paroxetine was effective, so she restarted it. Now she is pregnant and euthymic, but she is extremely worried about taking the drug. How do I explain the confusing information to her?

ANSWER: There has recently been an increase in the publication of studies reporting pregnancy outcomes associated with use of antidepressants; many focus on paroxetine, often with conflicting results. However, despite these studies and the precedent-setting lawsuit in which GlaxoSmithKline was ordered to pay $2.5 million to the family of a child with a heart defect whose mother took paroxetine in the first trimester of pregnancy, the evidence that paroxetine increases the rate of cardiac malformations above the population baseline risk of 1 out of 100 pregnancies just does not exist.