Is Oral Fluconazole To Blame for Miscarriages? FDA Issues a Safety Alert
Yeast infections and pregnancy often go hand-in-hand with yeast infections affecting about 10% of pregnant women. The first-line treatment is a topical azole product, but providers sometimes prescribe oral fluconazole for severe symptoms or due to patient preference. The current FDA label for oral fluconazole states that the data available does not suggest an increased risk of problems during pregnancy when women are exposed to a single 150 mg dose of oral fluconazole. However, high doses of oral fluconazole (400-800 mg/day) have resulted in reports of abnormalities at birth.
A recent nationwide cohort study conducted in Denmark found that women who took oral fluconazole had a significantly increased risk of miscarriage. The risk was significant compared with risk among unexposed women and women with topical azole exposure in pregnancy. Women in the study mostly took one or two 150-milligram doses of fluconazole – the dose that was previously considered safe.
The study authors note that until more data on the association are available, using oral fluconazole in pregnancy should be done with caution. The FDA concurred and released a safety alert advising cautious prescribing until the results of the Danish study and additional data can be evaluated. The FDA will communicate their final conclusions and recommendations when the review is complete.
Byline: Martha L. Sikes, MS,RPh, PA-C
Posted: May 6, 2016
Source: Journal of the American Medical Association (JAMA)
Adapted from the original article and FDA safety alert.
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