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The long-term treatment of high doses of the antifungal drug Diflucan (fluconazole), during the first trimester of pregnancy, might cause birth defects, warns the U.S. Food and Drug Administration (FDA).

Several drug companies market fluconazole under the brand name Diflucan. The drug is used to treat infections caused by fungus, including yeast infections of the mouth, vagina, throat and bladder. Patients with weakened immune systems from cancer treatments or bone marrow transplants are also given this drug to prevent infection.

The pregnancy category for high doses of Diflucan has changed from level C to D in response to animal studies and human case reports showing the link between birth defects and this drug.

According to the agency, there have been at least five reported cases of birth defects that include facial abnormalities, seen in infants whose mothers were treated with higher doses of the drug (400-800mg/day) during the first trimester of pregnancy.

Consumers are urged to report any adverse events or side effects related to the use of this drug to the FDA’s MedWatch Safety Information Reporting Program online at​MedWatch/​report.htm, or call 800-332-1088.

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