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Pharmaceuticals / Quality / Postmarket Safety

FDA Investigates Yeast Infection Drug

May 3, 2016

The FDA is looking into results from a Danish study that links a yeast infection treatment to an increased risk of miscarriage.

In a safety announcement, the FDA says that pregnant women taking high doses of the Diflucan — 400 to 800 mg a day — can result in birth abnormalities. Current labeling states study data do not suggest an increased risk of problems during pregnancy or abnormalities in developing babies when women are exposed to a single 150-mg dose.

The agency advises that pregnant women and those trying to get pregnant should talk to their healthcare providers about alternative treatments.

Results from the Danish study appeared in The Journal of the American Medical Association.


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