FDA Revises Diflucan Warning Label, Drug Linked to Birth Defects

Posted on August 11, 2011 at 5:00am by

According to About Lawsuits, the US Food and Drug Administration has issued a warning about birth defect risks associated with Diflucan, an antifungal drug used for treatment of yeast infections and meningitis. The drug safety communication issued by the FDA says that high doses of Diflucan has been associated with a number of rare and distinct birth defects and congenital anomalies.

The FDA had changed high-dose Diflucan treatments, 400-800 milligrams daily, from a Category C to Category D pregnancy drug label, meaning the drug has been shown to have positive human evidence of a risk of birth defects. The low dose Diflucan has not changed and remains Category C.

Diflucan is a prescription drug introduced by Pfizer used to treat yeast infections of the vagina, mouth, esophagus and other organs. It is also used to treat meningitis strains and can be used as a yeast infection preventative in patients undergoing cancer treatments before receiving a bone marrow transplant.

Studies have linked Diflucan to birth defects when taken in the first trimester, at the time when most women do not know they are pregnant, and when most birth defects seem to occur. Diflucan birth defects include abnormal head, skull, facial defects, cleft palate, cleft lip, bowing of the thigh bones, thin ribs, long bones, muscle weakness, joint deformities and congenital heart disease at birth.

Cappolino Dodd Krebs LLP. – birth trauma lawyers



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