Study Linking Diflucan with Higher Risk of Miscarriage Under FDA Review

The FDA is reviewing the results of a Danish study that found the oral use of fluconazole (Diflucan) for yeast infections may increase the risk of miscarriage.

The CDC currently recommends that pregnant women only use topical antifungal products to treat vulvovaginal yeast infections, even if infections persist for a long time or recur.

The FDA noted that results of its review will be made widely available once it is concluded.

Until then, the FDA encourages health care providers and individuals to be cautious about use of the drug during pregnancy. Patients who are actively trying to get pregnant should consult a health care professional before deciding to use Diflucan.

The drug’s current label does not include any information on potential pregnancy problems or abnormalities when taken at the 150 mg dose for vaginal yeast infections.

However, high doses of fluconazole (400-800 mg per day) taken by pregnant women for much longer than a single dose have been linked with birth abnormalities.

In the Danish study, most of the oral fluconazole use was 1 or 2 doses of 150 mg.

The FDA encourages all adverse effects to be reported to its MedWatch Safety Information and Adverse Event Reporting program either online or via mail.

“Use of oral fluconazole in pregnancy was associated with a statistically significant increased risk of spontaneous abortion compared with risk among unexposed women and women with topical azole exposure in pregnancy,” the Danish researchers wrote in their study published in JAMA. “Until more data on the association are available, cautious prescribing of fluconazole in pregnancy may be advisable.”