Federal Regulators Say Study Finds Diflucan Yeast Infection Drug Potentially Tied to Increased Risk of Miscarriage and Birth Defects

Diflucan is the brand name for the generic drug, fluconazole, which is prescribed to treat various fungal infections. Research results released by the U.S. Food and Drug Administration on April 26, 2016 indicate that a Danish study on Diflucan reveal that there exists a potential risk of adverse effects, specifically miscarriage, in women who take the medication during pregnancy. Babies of these women also appear to be at increased risks for birth defects.

The agency is reviewing the results of the Danish research and also just announced that it is reviewing additional information. The FDA indicated that it will follow-up with its final conclusions and recommendations.

Oral Diflucan is prescribed to treat infections of the vaginal area, mouth, and esophagus; to treat a fungal infection of the brain and spinal cord known as cryptococcal meningitis, which typically affects individuals who have been diagnosed with weakened immune systems; and is used to prevent yeast infections that may spread throughout the body in patients who have been diagnosed with cancer and who have a weakened immune system.

The current Diflucan drug label indicates that data available from human studies do not suggest the existence of an increased likelihood of health problems during pregnancy or abnormalities in developing babies when expectant women are exposed to a single 150 mg dose of oral fluconazole to treat vaginal yeast infections. High doses of oral fluconazole—400-800 mg/day—when taken by pregnant women for much more than the one dose have led to reports of birth abnormalities. The FDA notes that most of the oral fluconazole use documented in the Danish research appeared to involve just one or two doses of 150 mg oral Diflucan.

The FDA recommends that, until its review is complete and current research and other data is better understood, physicians should exert caution when prescribing oral fluconazole to pregnant women and that health care professionals should be aware that the U.S. Centers for Disease Control and Prevention (CDC) guidelines recommend only using topical antifungal products to treat pregnant women diagnosed with a vulvovaginal yeast infections. Of note, this includes treatment for longer periods than normal should infections persist or recur.

Pregnant patients, or patients who are attempting to conceive, are advised to speak with their health care providers about alternate yeast infection treatments options.

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