Drug for Yeast Infections Linked to Birth Defects
August 4, 2011
As if yeast infections weren’t common enough, thankyouverymuch, skinny jeans trend, they’re even more common during pregnancy. And while a low, 150 mg, single dose of fluconazole (Diflucan) appears to be a safe way to treat a vaginal yeast infection, the FDA has ordered new labeling for the drug, warning that if pregnant women take multiple, high doses of the antifungal, it may increase the risk of birth defects.
According to the FDA, the risk is seen with daily doses of 400 mg to 800 mg used during most or all of the first three months of pregnancy. Birth defects related to the drug include brachycephaly (flat head syndrome), abnormal development of the skullcap, cleft lip or palate and congenital heart disease.
In addition to the label change, the FDA has raised fluconazole from pregnancy category C to category D for all but single, low-dose treatments. Pregnancy category D means that there is positive evidence of risk to human fetuses—but the potential benefits from use of the drug during pregnancy due to serious or life-threatening conditions may outweigh its risks. Pregnancy category C means that there is evidence of fetal risk in animal studies but insufficient data for human patients.
Women should notify their doctor or midwife if they are or become pregnant while taking fluconazole.