FDA Releases Statement Concerning Paxil Birth Defects and Pregnancy

Also known by its generic name paroxetine, Paxil is one of the world's most widely prescribed antidepressants. Recently, however, Paxil's…

Also known by its generic name paroxetine, Paxil is one of the world’s most widely prescribed antidepressants. Recently, however, Paxil’s Pregnancy category class was updated.  What was changed during this update was moving Paxil to a category “D” medication instead of a category “C” for use during pregnancy. This change reflects a stronger warning about use during early pregnancy as there are chances for birth defects to occur. The drugs that belong to Category “D” have shown higher risks to fetuses in studies of pregnant women. The benefits of the therapy may outweigh the risks in using drugs from this category.

The FDA recently released a statement with regards to Paxil and pregnancy. The advisory released by the FDA states: “FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy. Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients. In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. FDA is advising health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate.”

Also according to the FDA, early results from the two studies showed that women who took Paxil during the first three months of pregnancy were about 1.5 to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. In one study, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2%, compared with a 1% risk in the whole population. While in another study it was stated that the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5%, compared with 1% in babies whose mothers had taken other antidepressants in the first three months of pregnancy.

The FDA has begun to warn about the potential side effects of Paxil especially those in pregnant women.  If you are thinking about starting Paxil for your signs and symptoms of depression, consult with your doctor first.