FDA: High-Dose Fluconazole Tied to Birth Defects

Chronic use during first trimester may lead to rare and distinct set of birth defects

WEDNESDAY, Aug. 3 (HealthDay News) -- The U.S. Food and Drug Administration has notified health care professionals and patients that treatment with chronic, high doses (400 to 800 mg/day) of fluconazole (Diflucan) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants.

Fluconazole is indicated for the treatment of yeast infections of the vagina, mouth, throat, esophagus, and other organs as well as to prevent yeast infections in those at high risk. The drug is also used to treat meningitis caused by a certain type of fungus. Based on the potential for birth defects associated with high doses of fluconazole used chronically, the pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. However, the risk of a rare and distinct set of birth defects does not appear to be linked to single use of low-dose fluconazole (150 mg) to treat vaginal yeast infections.

According to the FDA, pregnancy category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite its risks. The FDA issued the category change based on several published case reports of birth defects in infants whose mothers were treated with high-dose fluconazole (400 to 800 mg/day) for serious and life-threatening fungal infections during part or all of the first trimester.

According to the FDA, "health care professionals should counsel patients if the drug is used during pregnancy or if a patient becomes pregnant while taking the drug. Patients should notify their health care professionals if they are or become pregnant while taking fluconazole. If a patient uses fluconazole during pregnancy, the patient should be informed of the potential risk to the fetus."

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