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Diflucan May Be Linked to Birth Defects, Says FDA

Diflucan FDA WarningThe U.S. Food and Drug Administration (FDA) issued a safety communication on Aug. 3, 2011 to alert patients and health care providers about a possible risk of birth defects associated with long term use of the anti-fungal medication Diflucan®.

“The U.S. Food and Drug Administration (FDA) is informing the public that chronic, high doses (400-800 mg/day) of the antifungal drug Diflucan® (fluconazole) may be associated with a rare and distinct set of birth defects in infants whose mothers were treated with the drug during the first trimester of pregnancy,” the FDA said in the alert. “This risk does not appear to be associated with a single, low dose of fluconazole 150 mg to treat vaginal yeast infection (candidiasis).”

The information is based on published case reports of babies who were born with birth defects after their mothers were treated with 400-800 mg/day of Diflucan® during most or all of their first trimesters.

The FDA updated the pregnancy category from C to D, meaning there is evidence that the medication increases the risk of birth defects in infants whose mothers take Diflucan® during pregnancy. But, in cases of severe infection, the medication may still be prescribed to pregnant women despite the risks. The pregnancy category for the single dose (150 mg) has not been affected.

Risks for infants exposed to Diflucan® (fluconazole) include, “brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease.”

(Source: FDA)

If you were prescribed a high dose of Diflucan® (fluconazole) during your pregnancy and your baby has suffered one of these birth defects, you may be eligible for compensation. Contact a Diflucan® birth defect lawyer to find out if you qualify for compensation.