Paxil and Birth Defects

The FDA last month began advising health care providers and patients about the 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, anxiety and several other psychiatric disorders. FDA is currently 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.

The 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) for these patients. In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. The FDA is advising health care professionals not to prescribe Paxil to women who are in the first trimester of pregnancy or are planning to become pregnant, unless other treatment options are not appropriate.

The FDA is advising patients, among other things:

(1) Paxil 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;
(2) Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy;
(3) Women taking Paxil should not stop taking it without first talking with their physician.

The FDA reports that early results of two studies showed that women who took Paxil during the first three months of pregnancy were about 1.5 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 (holes in the walls of the chambers of the heart). 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.

Everything I have written above comes from the FDA. I have previously represented GlaxcoSmithKline in litigation involving Paxil and the question of whether Paxil can induce homicide/suicide in some patients. I have no inside knowledge about the question of whether Paxil causes birth defects. But if you are reading this looking for an attorney to handle your case, I will not take cases involving Paxil.

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