FDA: Fluconazole Linked to Increased Miscarriage Risk

WEDNESDAY, April 27, 2016 (HealthDay News) — Health care professionals should use caution when prescribing the oral antifungal drug fluconazole (Diflucan) during pregnancy because it may raise the risk of miscarriage, the U.S. Food and Drug Administration warns.

The agency said it is evaluating the results of a recent Danish study that suggested a link between fluconazole and miscarriage, along with additional data, and will release final conclusions and recommendations when the review is completed.

Current labeling information suggests that a single 150 mg dose of oral fluconazole to treat vaginal yeast infection is safe to take during pregnancy. However, the FDA noted that in rare cases higher doses taken during pregnancy (400 to 800 mg a day) had been linked to abnormalities at birth. In the Danish study, most of the fluconazole use appeared to be one or two doses of 150 mg.

“Until the FDA’s review is complete and more is understood about this study and other available data, the FDA advises cautious prescribing of oral fluconazole in pregnancy,” the agency said in a news release. The agency also noted that the U.S. Centers for Disease Control and Prevention recommends only antifungal creams to treat pregnant women with vaginal yeast infections — even for longer periods than usual if the infections persist or recur.

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