FDA Warns Against Chronic, High-dose Fluconazole During Pregnancy
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The U.S. Food and Drug Administration (FDA) warned today that high doses of fluconazole (400-800 mg/day) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. The birth defects were noted in women who received high doses of fluconazole for serious and life-threatening fungal infections during most or all of the first trimester.
The risk does not appear to be associated with the low dose of fluconazole (150 mg) to treat vaginal yeast infections (candidiasis).
A few published case reports describe a “rare pattern of distinct congenital anomalies in infants exposed in utero to high-dose maternal fluconazole during most or all of the first trimester,” says the FDA. Features seen in these infants include brachycephaly, abnormal looking face, abnormal development of the skullcap, cleft palate, femoral bowing, thin ribs and long bones, muscle weakness and joint deformities, and congenital heart disease.
The pregnancy category for a single dose of fluconazole (150 mg) to treat vaginal candidiasis has not changed and remains category C. However, the FDA has changed the pregnancy category for fluconazole indications (other than vaginal candidiasis) from category C to category D. Pregnancy category D means there is positive evidence of human fetal risk based on human data, but that 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 recommends that healthcare professionals counsel patients if the drug is used during pregnancy or if a patient becomes pregnant while taking the drug. If a patient uses fluconazole during pregnancy, the patient should be informed of the potential risk to the fetus.
More information on the alert is available on the FDA Website.
Adverse events involving fluconazole should be reported to the MedWatch Online, or call 1-800-332-1088.
Published on August 3, 2011
Source: FDA drug safety communication: Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants. U.S. Food and Drug Administration Website. http://www.fda.gov/Drugs/DrugSafety/ucm266030.htm. Updated August 3, 2011. Accessed August 3, 2011.