The FDA recently issued an alert based on early findings of two new studies suggesting that paroxetine (Paxil, GlaxoSmithKline [GSK]) increases the risk for congenital malformations, particularly those of a cardiac nature, when it is taken by women during the first trimester of pregnancy.

The as-yet-unpublished epidemiology studies indicate that women who take the drug during the first 3 months of pregnancy are one and a half to two times as likely to have a baby with a heart defect as women who take other antidepressants or none at all. Most of the defects consisted of atrial and ventricular septal defects, ranging in severity from minor to requiring surgical repair.

As a result of the studies, the FDA has asked and GSK has agreed to change the pregnancy category of paroxetine from C to D, which indicates that controlled or observational studies in pregnant women have demonstrated a risk to the fetus. The manufacturer has also added information to the Warnings section of paroxetine's labeling.

For more information, log onto FDA's Web site at: Public Health Advisory: http://www.fda.gov/cder/drug/advisory/paroxetine200512.htm and CDER Information Sheets: http://www.fda.gov/cder/drug/infopage/paroxetine/default.htm.