Diflucan Birth Defect Warnings Issued by FDA

Federal drug regulators are warning about a possible risk of birth defects from Diflucan, an antifungal drug used for treatment of yeast infections and meningitis. 

According to a drug safety communication issued by the FDA on Wednesday, high doses of Diflucan, which is known generically as fluconazole, has been associated with a number of rare and distinct birth defects and congenital anomalies.

The FDA has changed high-dose Diflucan treatments from a Category C to Category D pregnancy drug, meaning that there is positive human evidence of a risk of birth defects from Diflucan. The pregnancy category for single, low dose Diflucan has not changed and remains Category C, as the risk appears to be associated only with high dose treatments involving at least 400-800 milligrams daily.

Diflucan (fluconazole) is a prescription drug introduced by Pfizer used to treat yeast infections of the vagina, mouth, esophagus and other organs. It is also used to treat some kinds of meningitis and used as a yeast infection preventative in patients being treated with chemotherapy or radiation therapy before receiving a bone marrow transplant.

Generic Diflucan versions are also available from several drug makers.

Case studies have linked Diflucan to birth defects when taken in the first trimester, at time when many woman do not even know they are pregnant. According to the FDA, Diflucan birth defects seen in infants exposed to long-term, high-doses during the first trimester included abnormal head, skull and face defects, cleft palate, cleft lip, bowing of the thigh bones, thin ribs, long bones, muscle weakness, joint deformities and congenital heart disease at birth.

In the information provided to healthcare providers, the FDA discussed five case studies involving women who gave birth to children with birth defects after taking a high-dose, long-term regimen of Diflucan during their first trimester. Four of the cases were for the treatment of meningitis and one case involved an HIV-positive woman who had to receive chronic, high doses of Diflucan to treat a vaginal yeast infection. The FDA found that all of the women shared characteristics with the autosomal recessive genetic disorder known as Antley-Bixler syndrome.

None of the studies looked at by the FDA were large enough to calculate the increased risk of birth defects due to Diflucan side effects.