FDA Drug Safety Podcast: Long-term, high dosage use of Diflucan during pregnancy may lead to rare birth defects

On August 3, 2011 the Food and Drug Administration issued a Drug Safety Communication that explains how long-term, high dosage use of diflucan during pregnancy may be associated with rare birth defects.

I am Yolanda Fultz-Morris from F-D-A's Center for Drug Evaluation and Research. Fluconazole (floo kon' na zole), marketed under the name Diflucan, is an antifungal medication used to treat infections in the skin, the mucous membranes of the mouth, the respiratory tract, or the vagina.

Using Diflucan in doses from 400 to 800 milligrams, for several weeks or more, may be associated with a rare and distinct set of birth defects in infants. Usually, birth defects occurred when mothers were treated with the drug during the first trimester of pregnancy. The risk does not appear to be associated with a single, low dose of Diflucan at 150 milligrams, used to treat vaginal fungus infections.

FDA is informing health care providers and patients that Diflucan shows positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks. There are several published case reports of birth defects in infants whose mothers were treated with high-dose Diflucan for serious and life-threatening fungal infections during most or all of the first trimester.

Problems seen in these infants include muscle weakness, malformations of the face, including oral clefts, and abnormal development of the heart, bones and joints.

Healthcare professionals should be aware of the potential risks with long-term, high-dose use of Diflucan and should inform patients of those risks if the drug is used during pregnancy or if a patient becomes pregnant while taking the drug.

FDA urges healthcare providers and patients to report any adverse events or side effects that may be associated with the use of Diflucan to FDA's MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot GOV slash M-E-D-W-A-T-C-H.