Pregnant women taking large doses of the drug fluconazole (Diflucan) may have an increased risk of having babies with birth defects.
Pregnant women taking large doses of the drug fluconazole (Diflucan) may have an increased risk of having babies with birth defects, according to the US Food and Drug Administration.
The drug, which treats yeast infections of the vagina, mouth, throat, esophagus, and other organs, also treats meningitis caused by a certain type of fungus. It also prevents yeast infections in patients undergoing chemotherapy or radiation therapy prior to a bone marrow transplant.
The FDA said constant, high doses (400 to 800 milligrams per day) of fluconazole during the first trimester of pregnancy might increase the risk of a rare and distinct set of birth defects. A low dose (150 milligrams) to treat vaginal yeast infection did not seem to have any increased risk. Based on this information, the FDA has changed the pregnancy category for extensive, high-dose fluconazole use (other than vaginal yeast infection) from category C to category D.
While the single, low-dose of fluconazole did not change and remained in category C, the high-dosage of the drug in category D now means that there is evidence of the drug’s risks to human fetuses, but is still acceptable due to the potential benefits of pregnant women with serious or life-threatening conditions who use it.
The FDA also announced that women on fluconazole during pregnancy should be informed of the potential risks to the fetus, and women who are or become pregnant while taking fluconazole should notify their health care providers.
Around the Web
High Dose of Yeast Infection Drug Linked to Birth Defects, FDA Says [US News & World Report]
FDA Says High Doses Of Antifungal Drug Fluconazole Might Cause Birth Defects [Wall Street Journal]