The FDA is evaluating the results of a Danish study that concluded there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan, Pfizer, and generics) for the treatment of yeast infections. The agency says it will communicate its final conclusions and recommendations when the review is complete.
The current labeling for 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 to 800 mg per 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.
Oral fluconazole is used to treat yeast infections of the vaginal area, mouth, and esophagus, and to treat cryptococcal meningitis, a fungal infection of the brain and spinal cord that usually affects people with weakened immune systems. The drug is also used to prevent yeast infections that can spread to the rest of the body in cancer patients who have a weakened immune system.
Until the FDA’s review is complete and more is understood about this study and other available data, the agency advises cautious prescribing of oral fluconazole in pregnancy.
Health care professionals should be aware that the Centers for Disease Control and Prevention guidelines recommend using topical antifungal products only to treat pregnant women with vulvovaginal yeast infections, including for longer periods than usual if these infections persist or recur, the FDA says.
Women who are pregnant or actively trying to get pregnant should talk with their health care professionals about alternative treatment options for yeast infections.
In 2011, the FDA issued a safety communication stating that long-term use of high-dose (400 to 800 mg per day) fluconazole during pregnancy may be associated with birth defects in infants. Based on this information, the pregnancy category for fluconazole indications (other than vaginal candidiasis) was changed from category C to category D. The pregnancy category for a single dose of fluconazole 150 mg to treat vaginal candidiasis was not changed and remained category C.