FDA Warns of Birth Defects Associated with High Dose Diflucan (Fluconazole)

Washington, DC: The Food and Drug Administration (FDA) is informing the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants.

There are several published case reports of birth defects in infants whose mothers were treated with high-dose fluconazole (400-800 mg/day) for serious and life-threatening fungal infections during most or all of the first trimester, the FDA said.

Features seen in infants exposed to long-term, high-dose Diflucan in utero include a short, broad head; abnormal looking face; abnormal development of the skullcap; oral cleft (opening in the lip or palate); bowing of the thigh bones; thin ribs and long bones; muscle weakness and joint deformities; congenital (present at birth) heart disease.

In a statement released August 3, 2011, the agency states that the "risk does not appear to be associated with a single, low dose of fluconazole 150mg to treat vaginal yeast infection (candidiasis). Based on this information, the pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. The pregnancy category for a single, low dose of fluconazole has not changed and remains category C."

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.

Diflucan is used to treat yeast infections of the vagina, mouth, throat, esophagus and other organs. It is also used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before bone marrow transplant. Diflucan is also used to treat meningitis caused by a certain type of fungus.

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Published on Aug-3-11