The FDA announced yesterday that long-term, high-dose use of the antifungal medication, fluconazole, may cause rare birth defects in infants. According to the regulatory agency, a one-time, 150mg dose of the drug used to treat a vaginal yeast infection is not associated with the link to birth defects. However, there have been approximately five reported cases of birth defects seen in babies whose mothers were treated with 400-800mg doses of fluconazole per day during the first trimester of their pregnancy.
Based on this new information, the FDA has changed the pregnancy category used for high doses of fluconazole from category C to category D. A label containing “pregnancy category D” means there is evidence of fetal risk based on human data. Fluconazole is primarily used to treat yeast infections of the vagina, mouth, throat, esophagus and other organs and is marketed by a number of different generic drug companies, as well as under the brand name, Diflucan by Pfizer.
The FDA recommends that healthcare professionals counsel patients regarding the potential risks if the drug is used during pregnancy or if a patient becomes pregnant while on taking the drug. The agency also encourages doctors and patients to report any adverse events experienced as a result of the use of fluconazole.