FDA Says High Doses Of Antifungal Drug Fluconazole Might Cause Birth Defects

By Jennifer Corbett Dooren, Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration said Wednesday long-term treatment with high doses of the antifungal drug fluconazole in the first trimester of pregnancy might cause birth defects.

Fluconazole is marketed by several generic drug companies and under the brand name Diflucan by Pfizer Inc. (PFE). The product is used to treat certain kinds of yeast infections and meningitis caused by a type of fungus. Fluconazole is also used to prevent yeast infections in patients being treated with chemotherapy or radiation before a bone-marrow transplant.

The FDA said that the typical one-time, 150 milligram dose used to treat vaginal yeast infections is not associated with a risk of birth defects.

However, there have been at least five reported cases of birth defects, that include facial abnormalities, seen in infants whose mothers were treated with 400-to-800 milligrams of fluconazole per day during the first trimester of pregnancy.

The agency changed the pregnancy category for most uses of fluconazole to " pregnancy category D" which means there's evidence of fetal risk based on human data, but the potential benefits from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable, according to FDA.

A pregnancy category appears on drug labels written for health-care professionals. The agency said the category wasn't being changed for the 150 milligram dose used to treat vaginal yeast infections.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com