The FDA ( U.S. Food and Drug Administration ) has informed Health Care Professionals and patients about early results of new studies for Paxil ( Paroxetine ) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy.

Paxil is approved for the treatment of depression and several other psychiatric disorders.

FDA is gathering additional data and waiting for the final results of the recent studies in order to better understand the higher risk for birth defects that has been seen with Paxil.

Health Care Professionals should 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. Health Care Professionals should not prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate.

The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half 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. Most of the heart defects reported in these studies were atrial and ventricular septal defects.
In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.

In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.

Source: FDA, 2005


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