FDA Evaluating Study and Examining Use of Oral Fluconazole (Diflucan) in Pregnancy

A Danish study has concluded that there may be an increased risk of miscarriages with use of oral fluconazole for yeast infections.  Oral fluconazole is sold under the brand name Diflucan and also as generics.  It is used to treat yeast infections of the vaginal area, esophagus, and mouth and can treat some fungal infections.  It is also used to prevent yeast infections in cancer patients who have a weakened immune system.  Current FDA data from studies does not suggest a heightened risk of complications during pregnancy or abnormalities in babies when associated with a single 150 mg dose of oral fluconazole to treat vaginal yeast infections.  However, abnormalities at birth have been reported when pregnant women take a higher dose or oral fluconazole (400-800mg/day) for much longer than a single dose.  In contrast, most of the Danish study consisted of one or two doses of 150 mg of oral fluconazole.

The FDA is currently evaluating the results of the Danish study and other data and will issue final conclusions and recommendations once the review is complete.  Until then, the FDA urges caution when prescribing oral fluconazole in pregnancy.  The CDC recommends that pregnant women with vulvovaginal yeast infections treat only using tropical antifungal products.  The FDA recommends that patients who are pregnant or trying to become pregnant discuss alternative treatment options for yeast infections with their health care professionals.

To read more or submit a report of adverse events or side effects related to use of this product, please visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm497656.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery