NGC Update Service: May 2, 2016 ► U.S. Food and Drug Administration (FDA) Advisory

NGC Update Service: May 2, 2016

U.S. Food and Drug Administration (FDA) Advisory

• April 26, 2016: Fluconazole (Diflucan): FDA is evaluating the results of a Danish study that conclude there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan) for yeast infections. FDA is also reviewing additional data and will communicate final conclusions and recommendations when the review is complete.The current FDA drug label states that data available from studies in people 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 to treat vaginal yeast infections. However, high doses of oral fluconazole (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.