In December 2005, the Food and Drug Administration and GlaxoSmithKline issued a public health advisory warning pregnant women and physicians of the risks associated with taking Paxil during pregnancy and the increased risk of congenital heart defects. This new warning was issued on the basis of two new studies investigating the risk of Paxil side effects and moves the drug into the FDA’s second highest risk category for risk of birth defects.

The studies found that women who take Paxil during the first trimester were up to twice as likely to give birth to an infant with a heart defect as women who take other antidepressants. Most of the Paxil-related congenital heart defects were atrial and ventricular septal defects, or holes in the heart walls. Often times these birth defects will heal on their own. However, some will require surgery to repair.

The FDA is advising health care professionals not to prescribe Paxil to women who are in their first three months of pregnancy or are planning to become pregnant. Earlier this year the FDA issued a warning that Paxil may be associated with an increased risk of birth defects.

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