High-Dose Diflucan Treatment Risky in Early Pregnancy, FDA warnsAug 3, 2011 | Parker Waichman LLP
A Drug Safety Communication issued today by the U.S. Food & Drug Administration (FDA) warned that chronic use of high-dose (400-800 mg/day) Diflucan or generic fluconazole during early pregnancy might be associated with the development of certain rare birth defects. In the communication, the FDA said it would be reclassifying most uses of Diflucan - with the exception of the 150 mg/day used for vaginal yeast infections, which will remain in Category C - to a higher pregnancy risk category.
The new category for most Diflucan indications - Pregnancy Category D - means there's evidence of 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, according to FDA.
Diflucan is used to treat certain kinds of yeast infections and meningitis caused by a type of fungus. Fluconazole is also used to prevent yeast infections in patients being treated with chemotherapy or radiation before a bone-marrow transplant. In addition to Diflucan, fluconazole is sold by several companies as a generic drug.
According to the FDA, it is aware of five case reports in the medical literature that describe rare and distinct birth defects in infants whose mothers were treated with chronic high-dose (400-800 mg/day) Diflucan for serious fungal infections in the first trimester of pregnancy. Four involved expectant mothers treated with chronic high-dose intravenous Diflucan for coccidioidal meningitis. The fifth involved a case where an HIV-positive mother received high-dose Diflucan for a vaginal yeast infection.
The five cases in the medical literature all shared some characteristics with the autosomal recessive genetic disorder known as Antley-Bixler syndrome, the FDA said. This combination of congenital anomalies occurs rarely in the general population, and is similar to anomalies seen in animals following in utero Diflucan exposure. Birth defects that may result from chronic, high-dose Diflucan use may include brachycephaly, facial abnormalities, abnormal skull cap development, cleft palate, thigh bowing, thin ribs and long bones, muscle weakness and joint defects, and congenital heart disease, the agency said.
The FDA said doctors should be aware of the potential risks with long-term, high-dose use of Diflucan and counsel patients if the drug is used during pregnancy or if a patient becomes pregnant while taking the drug.
Patients should notify their healthcare professional if they are pregnant or become pregnant while taking Diflucan.