- Copyright © 2011, The American Academy of Pediatrics
Chronic, high doses (400 mg/day) of the antifungal drug Diflucan (fluconazole) 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, according to the Food and Drug Administration (FDA).
The risk does not appear to be associated with a single, low dose of fluconazole (150 mg) to treat vaginal candidiasis.
Some published case reports describe birth defects in infants born to mothers who took 400- to 800 mg/day of fluconazole during most or all of their first trimester to treat serious and life-threatening fungal infections.
Based on the information, the FDA changed the pregnancy category for fluconazole indications other than vaginal candidiasis from category C to category D. That means there is positive evidence of human fetal risk based on human data, though potential risks from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite the risks.
The features seen in the exposed infants included brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis and congenital heart disease.
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 the drug during pregnancy, she should be informed of the potential risk to the fetus.
Report adverse events or side effects related to the use of this drug to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online at www.fda.gov/MedWatch/report.htm, or call 800-332-1088 to request a reporting form. To access the FDA MedWatch advisory, go to www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266468.htm.