Pregnancy and Birth Defect Warning: Diflucan (fluconazole)

Yesterday, the FDA warned that the drug Diflucan (fluconazole) can result in rare and distinctive birth defects if taken during the first trimester of pregnancy.

The FDA Safety Information and Adverse Event Reporting Program issued this safety alert to obstetricians, gynecologists, pharmacists, and infectious disease physicians, as well as the general public.

In fact, the FDA has changed the pregnancy category for extended, high-dose fluconazole use (other than vaginal yeast infection) from category C to category D.  This means that there is evidence that the drug poses a risk to human fetuses, but may still be acceptable due to the potential benefits for use in pregnant women with serious or life-threatening conditions.

The Food and Drug Administration approved fluconazole in January 1990.  Diflucan is typically used to treat several fungal infections such as yeast infections of the vagina, mouth, throat, esophagus (tube leading from the mouth to the stomach), abdomen (area between the chest and waist), lungs, blood, and other organs.  Diflucan is also used to treat meningitis (infection of the membranes covering the brain and spine) that is caused by fungus and sometimes to prevent yeast infections in patients being treated with chemotherapy or radiation therapy before a bone marrow transplant.

Fluconazole is sold as a tablet and a suspension (liquid) to take by mouth.  It is usually taken once a day.  Some may need to take only one dose of fluconazole; however, others may need to take fluconazole for several weeks or longer.

So what should you do? The FDA has recommended that patients who currently take the drug notify their healthcare professional if they are or become pregnant while taking fluconazole.    The FDA has also asked healthcare professionals and patients to report adverse events or side effects related to this drug to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.