Wednesday, August 3, 2011

FDA Alert - Diflucan (fluconazole) - Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects
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Alert FDA MedWatch Alert
Sent to subscribers of: fluconazole systemic
August 3, 2011
Audience: OBGYN, Pharmacy, Infectious Disease.
ISSUE: FDA is informing the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (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 vaginal yeast infection (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.
FDA Consumer Updates
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