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FDA Warns Paxil Could Increase Risk of Birth Defects

When taken in first trimester, the risk of infant cardiac defects is higher

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MONDAY, Dec. 12 (HealthDay News) -- The U.S. Food and Drug Administration warned that Paxil (paroxetine) could increase the risk of birth defects, particularly cardiac defects, if taken during the first three months of pregnancy. Paxil should not be taken during pregnancy unless other treatment options are not available, the FDA said in a statement.

The FDA move follows early results of two studies showing that women on Paxil in the first trimester of pregnancy were about twice as likely to have an infant with a heart defect as women on other antidepressants or in the general population, the FDA said.

The FDA asked the manufacturer, GlaxoSmithKline, to change the drug's pregnancy category to warn that studies show risks to the fetus in early pregnancy. The company updated the drug's label in September 2005 to reflect data from one study, the FDA said.

Physicians with patients on Paxil and planning pregnancy or in its early stages should discuss the possible risks and consider switching drugs, the FDA said.

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