FDA: Do Not Give Pregnant Women Oral Fluconazole

Oral fluconazole (Diflucan) is used to treat yeast infections; but the Food and Drug Adminstration (FDA) is warning that the drug could be linked to miscarriages.

Back in 2011, the FDA warned that the medication may cause birth defects in infants if the mother was treated during the first trimester. The research continued and a Danish study published in JAMA this past January concluded that oral fluconazole was linked to spontaneous abortion.

Currently, the drug label says that a single 150 mg dose of oral fluconazole does increase pregnancy or abnormalities risks — but it does say that 400 to 800 mg a day can increase these risks. The JAMA study, however, included mostly one or two doses of 150 mg of the medication.

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The latest development in this story comes from an advisory issued by the FDA on April 26. The agency is reviewing the study data and until more is known about the potential association, women who are pregnant or trying to get pregnant should avoid oral fluconazole.

“Healthcare professionals should be aware that the Centers for Disease Control and Prevention guidelines recommend only using topical antifungal products to treat pregnant women with vulvovaginal infections,” the statement said.

More information will be released once the reviewing process is complete.

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