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In December 2005, the FDA changed the pregnancy category of paroxetine from C to D, citing preliminary results from two studies indicating that the drug increases risk for congenital malformations. A drug is classified as category C when animal studies have shown an adverse effect on the fetus, there are no adequate studies in humans, and the drug's potential benefits to pregnant women may outweigh potential risks. For a drug to be placed in category D, there must be evidence of human fetal risk, but the benefits may still outweigh the risks (see http://www.safefetus.com/fda_category.asp).
The FDA advises that patients taking paroxetine who become pregnant or are in the first trimester of pregnancy be alerted to the potential fetal risk, and…