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Fluconazole under USFDA scanner for safety concerns

29-Apr-2016

Based on the results of a Danish study, the United States Food and Drug Administration (USFDA) is now evaluating the possible risk of miscarriage linked with oral Fluconazole (Diflucan) treatment for yeast infections. Additionally, other available data are being reviewed by the agency, the recommendations and conclusions will be announced upon the completion of the review.

 

As of now, no labeled warning has been given about the miscarriage risk or risk of teratogenicity after 150 mg of Fluconazole administration. However, higher dose of Fluconazole (400-800/day) is contraindicated in pregnant women due to increased risk of teratogenicity.

 

The present study employed one or two doses of 150 mg of Fluconazole.

 

The agency has issued an advice to the physicians to prescribe oral Fluconazole cautiously, particularly for pregnant women.

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