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FDA Evaluating Risk of Miscarriage with Oral Fluconazole in Pregnancy


Santa Clara, CA: The US Food and Drug Administration (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. The 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 fluconazole birth defects. In the Danish study, most of the oral fluconazole use appeared to be one or two doses of 150 mg.

Oral fluconazole is used to treat yeast infections of the vaginal area, mouth, and esophagus. It is also used to treat a fungal infection of the brain and spinal cord called cryptococcal meningitis that most often affects people with weakened immune systems, and used to prevent yeast infections that can spread to the rest of the body in cancer patients who have a weakened immune system. It is available under the brand name Diflucan and also as generics.



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