[Posted 04/26/2016]

AUDIENCE: Internal Medicine, Family Practice, OB/GYN

ISSUE: 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) for yeast infections. FDA is also reviewing additional data and will communicate final conclusions and recommendations when the review is complete.

The current FDA drug label 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 (400-800 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 one or two doses of 150 mg.

BACKGROUND: Oral fluconazole is used to treat yeast infections of the vaginal area, mouth, and esophagus. It is also used to treat a fungal infection of the brain and spinal cord called cryptococcal meningitis that most often affects people with weakened immune systems, and used to prevent yeast infections that can spread to the rest of the body in cancer patients who have a weakened immune system. It is available under the brand name Diflucan and also as generics.

RECOMMENDATION: 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.

Health care 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/26/2016 - Drug Safety Communication - FDA]