FDA Warns Birth Defects with Paxil

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by Anai Rhoads

The Food and Drug Administration (FDA) is advising that birth defect warnings should to be added to the prescription-only antidepressant, Paxil (Paroxetine).

Researchers are investigating the link between fetal heart defects and Paxil used by women in the first trimester of pregnancy. Early results suggest the drug increases the risk of this and other birth defects. The agency is waiting to hear the final results of the recent studies, but still warn the preliminary results require immediate label changes.

Heart defects in babies whose mothers had taken Paxil in the first trimester of pregnancy showed a 2% risk, compared to a 1% risk in the whole population. Mothers who took other antidepressants showed a 1% chance of birth defects.

A majority of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). Although some were found to be minor, others required surgery to repair.

FDA has asked the manufacturer of Paxil, Glaxo Smith Kline (GSK), to update the pregnancy category to a stricter warning, from C to D. Category D are medications not recommended to pregnant women.

Paxil is approved for the treatment of depression and several other psychiatric disorders. In May 1996, The agency approved Paxil for the treatment of Panic Disorder. Four years later, Paxil was approved for the treatment of Social Anxiety Disorder, and by 2001, Post Traumatic Stress Disorder (PTSD), and Generalised Anxiety Disorder (GAD) were added to the approved list.

Women planning to become pregnant, or are pregnant, will no longer be advised to use Paxil. The FDA now recommends all health care workers instead offer alternative antidepressants that have lower risk of fetal defects.

Additional Information Provided by the FDA:

Paxil
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