FDA warns about oral antifungal use during pregnancy

June 10, 2016

A Danish study has found a possibility of increased risk of miscarriage in pregnant women who use oral fluconazole to treat yeast infections.

FDA is evaluating the results of a Danish study that finds a possibility of increased risk of miscarriage in pregnant women who use oral fluconazole (Diflucan; Pfizer) to treat yeast infections.

See also: Antifungal dosing errors prompt FDA warning

Single vs. multiple doses 

FDA is reviewing additional data and will announce 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 stated in a Drug Safety Communication.

The current label for Diflucan (and for generic fluconazole) states that data available from studies in human subjects do not suggest either 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.

High doses of oral fluconazole (such as 400 mg–800 mg/day), however, taken more than once by pregnant women, have resulted in reports of abnormalities at birth. In the Danish study, most of the oral fluconazole use appeared to amount to one or two 150-mg doses.

See also: Fluconazole in early pregnancy may cause birth defects, FDA warns

Topical recommended

FDA advises healthcare professionals to be aware that the guidelines published by the Centers for Disease Control and Prevention recommend that only topical antifungal products be used to treat pregnant women with vulvovaginal yeast infections, including in cases when infections persist or recur and treatment is necessary for longer periods than usual.

“Patients who are pregnant or actively trying to get pregnant should talk to their healthcare professionals about alternative treatment options for yeast infections,” FDA said.

About oral fluconazole

Oral fluconazole is used to treat yeast infections of the vaginal area, mouth, and esophagus. It is also used to treat cryptococcal meningitis and to prevent yeast infections that can spread to the rest of the body in cancer patients.