FDA Drug Safety Podcast: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy
Welcome to FDA Drug Safety Podcasts for health care professionals. This is Lesley Navin Advanced Practice Nurse from the Division of Drug Information.
On April 26, 2016 FDA announced that it is evaluating the results of a Danish study that conclude there is a possible increased risk of miscarriage with the use of oral fluconazole (brand name Diflucan) for yeast infections. We are also reviewing additional data and will communicate our final conclusions and recommendations when our review is complete.
Health care professionals should be aware that the CDC guidelines recommend only using topical antifungal products to treat pregnant women with vulvovaginal yeast infections, including for longer periods than usual if these infections persist or recur.
Oral fluconazole is available under the brand name Diflucan and also as generics. The current FDA drug label states that data available from human studies 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 of oral fluconazole. However, high doses (400-800 mg/day) taken by pregnant women for much longer than a single dose have resulted in reports of abnormalities at birth. In the Danish study, most of the oral fluconazole use appeared to be one or two doses of 150 mg.
Until FDA's review is complete and more is understood, we advise cautious prescribing of oral fluconazole in pregnancy.
Side effects involving fluconazole should be reported to FDA’s MedWatch program at www.fda.gov/medwatch. A link to the full communication can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at firstname.lastname@example.org.
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