FDA Alert - Drug Safety Communication: Diflucan (fluconazole) - Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects

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FDA MedWatch Alert Sent to subscribers of: fluconazole systemic Drug Safety Communication: Diflucan (fluconazole) - Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects 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. Read more... Get these updates via twitter

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