Diflucan Use During Pregnancy Can Lead to Birth Defects

In August, the U.S. Food and Drug Administration (FDA) warned that chronic use of Diflucan (fluconazole) during the first trimester of pregnancy can lead to birth defects. The risk of birth defects is associated with chronic use of the drug in high doses (400-800 mg per day). So far, no such risk has been identified for the single, low dose of the drug (150 mg) used to treat yeast infections. Mothers who are concerned their child's birth defect may be the result of the chronic use of high-dose Diflucan during the first trimester of their pregnancy should discuss their case with a qualified drug attorney.

While no drug recall has been issued for high-dose fluconazole, the FDA did change the pregnancy category for this dangerous drug from C to D (except for low doses used to treat yeast infections). Category C means animal studies have shown adverse effects on fetuses, but no human studies have shown the same. Category D, on the other hand, means positive evidence exists concerning human fetal risk. If your baby was born with a birth defect and you were prescribed a potentially dangerous drug during your pregnancy, like high-dose Diflucan, an experienced drug lawyer may be able to help.

Four cases in which Diflucan use resulted in birth defects involved mothers receiving high doses of the drug intravenously to treat coccidioidal meningitis, while one case involved an HIV-positive mother receiving high doses of the drug orally on a regular basis to treat recurrent yeast infections. The reported birth defect is "a rare pattern of distinct congenital abnormalities," according to the FDA. More specifically, the defect is a rare genetic disorder known as Antley-Bixler syndrome. The FDA reports that animal studies show similar congenital anomalies in animals exposed to fluconazole in utero.

A drug can be dangerous even if it's not a recalled drug. Drugs we take every day come with the risk of side effects, some serious. Category D drugs - meaning fetal risk has been scientifically proven - may still be prescribed to pregnant women when a healthcare provider determines the benefit of the drug outweighs the potential fetal risk. If you were prescribed a dangerous or defective drug during your pregnancy and your child was born with a birth defect, contact a knowledgeable drug attorney today to learn about your legal rights.