The U.S. Food & Drug Administration (FD) warned today that chronic, high-dose treatment with <"http://www.yourlawyer.com/topics/overview/diflucan-birth-defects-side-effects-lawsuit">Diflucan (fluconazole) could be associated with the development of some rare birth defects. In a Drug Safety Communication, the agency said it was 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.
In its Drug Safety Communication, the FDA said it was moving most uses of fluconazole to “Pregnancy Category D,” which 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. However, the Pregnancy Category for the 150 mg dose of Diflucan used to treat most vaginal yeast infections will remain Category C.
According to the FDA, the cases reviewed in the medical literature included four where expectant mothers were 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.
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 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.
The FDA is advising doctors to 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 Diflucan.
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.