Low-Dose Fluconazole in Pregnancy Worries FDA

April 26, 2016

Clinicians should exercise caution prescribing oral fluconazole (Diflucan, Pfizer) to treat yeast infections in pregnant women in light of evidence that even low doses may cause miscarriages, the US Food and Drug Administration (FDA) said today.

The agency noted that the Centers for Disease Control and Prevention recommends prescribing only topical antifungal products for pregnant women with vulvovaginal yeast infections, including those that persist or recur.

Oral fluconazole is indicated for yeast infections of the vagina area, mouth, and esophagus, as well as for cryptococcal meningitis. It also is approved to prevent yeast infections in patients with cancer with weakened immune systems.

In 2011, the FDA warned that chronic use of fluconazole in daily doses of 400 to 800 mg during the first trimester of pregnancy may be associated with brachycephaly, cleft palate, and other birth defects in infants. The agency said at that time that available human data do not suggest a higher risk for birth defects after a single, 150-mg dose of oral fluconazole taken by a pregnant woman, a statement that appears on the current label for the drug.

In today's announcement, the FDA pointed to a recent Danish study reporting that pregnant women who took oral fluconazole for yeast infections during the seventh through 22nd weeks of gestation had a significantly higher risk for miscarriages. "Most of the oral fluconazole use appeared to be one or two doses of 150 mg," the agency said in a news release.

The FDA will review the Danish study, as well as additional data about the use of fluconazole in pregnant women, and share its conclusions and recommendations when the study is over. "Until FDA's review is complete and more is understood about this study and other available data, we advise cautious prescribing of oral fluconazole in pregnancy," the agency said. Women who are pregnant or trying to become pregnant should talk to their clinician about alternative treatments for yeast infections.

More information about today's announcement is available on the FDA website.

To report any problems with oral fluconazole, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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