FDA Warns Antifungal Diflucan (fluconazole) Used During Pregnancy Can Cause Birth Defects

August 3, 2011

Government regulators say women who take high doses of the antifungal medication Diflucan (fluconazole) during the first trimester of pregnancy may be at risk of harming their unborn child.

The U.S. Food and Drug Administration (FDA) announced that Diflucan (fluconazole) could cause birth defects in the babies of women who take long term, high doses of 400-800 mg per day during the first trimester of their pregnancy. Babies born after exposure to Diflucan in the womb during this time can suffer birth defects such as deformities of the head resulting in a short, broad head, abnormal looking face or oral cleft, bowing of thigh bones, thin ribs and long bones, muscle weakness, joint deformities and congenital heart defects.

Doctors prescribe Diflucan (fluconazole) for the treatment of fungal infections in the vagina, mouth, throat, esophagus, abdomen, lungs, organs or blood. It is also used to treat meningitis caused by fungus and for the prevention of fungal infections in people undergoing chemotherapy or radiation therapy.

“Healthcare professionals should counsel patients if the drug is used during pregnancy or if a patient becomes pregnant while taking the drug,” the FDA said. “Patients should notify their healthcare 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.”

The FDA is changing the drug from a Category C to a Category D in response to animal studies and human case reports showing the link between birth defects and Diflucan. Category D designates a drug with “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.”

According to the FDA, a single dose of fluconazole 150 mg to treat vaginal yeast infection during pregnancy does not appear to be associated with the birth defects.