ROCKVILLE, Md — August 3, 2011 — The US Food and Drug Administration (FDA) is informing the public that treatment with high doses (400-800mg/day) of fluconazole during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants.
This risk does not appear to be associated with a single, low dose of fluconazole 150mg to treat candidiasis.
Based on this information, the pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. The pregnancy category for a single, low dose of fluconazole has not changed and remains category C.
Healthcare professionals should counsel patients if the drug is used during pregnancy or if a patient becomes pregnant while taking the drug. Patients should notify their healthcare professionals if they are or become pregnant while taking fluconazole. If a patient uses fluconazole during pregnancy, the patient should be informed of the potential risk to the fetus.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
· Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
SOURCE: US Food and Drug Administration