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News From the Food and Drug Administration
June 7, 2016

Fluconazole Under Review

Author Affiliations

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;315(21):2268. doi:10.1001/jama.2016.6558

Recently published data indicating that oral fluconazole taken during pregnancy may increase the risk of miscarriage are under FDA review.

Oral fluconazole sometimes is used to treat vaginal yeast infections during pregnancy if symptoms are severe or recur or topical treatment fails. But in a study of 1.4 million pregnancies recorded in a Danish national register from 1997 to 2013, researchers showed that those who took oral fluconazole in the seventh week of pregnancy or later had a 48% increased risk of miscarriage compared with women who didn’t take the drug or used intravaginal topical azoles (Mølgaard-Nielsen D et al. JAMA. 2016;315[1]:58-67).

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