FDA is evaluating the results of a Danish study that conclude there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan, Pfizer) for yeast infections.
FDA is reviewing additional data and will communicate final conclusions and recommendations when the review is complete. “Until FDA's review is complete and more is understood about this study and other available data, FDA advises cautious prescribing of oral fluconazole in pregnancy,” the agency said in a MedWatch Safety Alert.
The current label for Diflucan (and generic fluconazole) states that data available from studies in people do not suggest an increased risk of problems during pregnancy or abnormalities in developing babies when women are exposed to a single 150 mg. dose of oral fluconazole to treat vaginal yeast infections.
However, high doses of oral fluconazole (400 mg to 800 mg/day) taken by pregnant women for much longer than a single dose have resulted in reports of abnormalities at birth. In the Danish study, most of the oral fluconazole use appeared to be 1 or 2 doses of 150 mg dose.
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 yeast infections, including for longer periods than usual if these infections persist or recur.
“Patients who are pregnant or actively trying to get pregnant should talk to their health care professionals about alternative treatment options for yeast infections,” FDA said.
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