FDA: Yeast Infection Drug Might Increase Miscarriage Risk

Kristin J. Kelley, Edited by Lorenzo Di Francesco, MD, FACP, FHM

Prescribing oral antifungal fluconazole (Diflucan & generics) to pregnant women, might pose increased miscarriage risk.

The warning follows the results of a recent Danish study in which the risk for spontaneous abortion was significantly higher among women who used oral fluconazole (hazard ratio, 1.48).

In the study, fluconazole was most often taken as one or two 150­mg doses, the FDA notes. The agency warned in 2011 that using high-dose fluconazole in the first trimester could cause birth defects, but the drug’s current label says the available data do not suggest an increased risk for pregnancy problems with a single 150­mg dose.


Dr. Allison Bryant of NEJM Journal Watch Women’s Health: “providers should take note and should not consider fluconazole as a first-line treatment for vaginal yeast infections in early pregnancy.”

Personal comment: There is no replacement for keeping up with the literature in order to provide safe care for patients.


FDA MedWatch safety alert (Free)

Background: Physician’s First Watch coverage of Danish study (Free)