Birth Defects May Occur From Long-Term Use of Fluconazole in Pregnancy

The FDA has issued a drug safety communication about fluconazole: long-term use at high dosages (400 to 800 mg/d) may be associated with a rare and distinct set of birth defects in infants whose mothers were treated with the drug during the first trimester of pregnancy.1 This risk does not appear to be associated with a single, low dose (150 mg) of fluconazole to treat vaginal yeast infection (candidiasis).

For indications of fluconazole other than vaginal candidiasis, the pregnancy category for fluconazole has been changed from category C to category D, meaning that there is evidence of human fetal risk based on human data but the potential benefits from the use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite its risks. The pregnancy category for a single dose of 150 mg of fluconazole for vaginal candidiasis remains category C.

Features prominent in infants with long-term exposure to high doses of fluconazole may include brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease.

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Drug Information: Fluconazole

References:

Reference

1. US Food and Drug Administration. FDA drug safety communication:

Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants

. August 3, 2011. Accessed August 11, 2011.