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High Dose Of Yeast Infection Drug Linked To Birth Defects, FDA Says | Debary Malpractice Attorney

High Dose Of Yeast Infection Drug Linked To Birth Defects, FDA Says

High doses of the antifungal drug fluconazole (brand name Diflucan) 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, according to the U.S. Food and Drug Administration.

The drug is used to treat yeast infections of the vagina, mouth, throat, esophagus and other organs. It’s also used to treat meningitis caused by a certain type of fungus and to prevent yeast infections in patients undergoing chemotherapy or radiation therapy prior to a bone marrow transplant.

According to the FDA, there are several published case reports of birth defects in infants whose mothers were treated with high-dose fluconazole (400-800 mg/day) for serious and life-threatening fungal infections during most or all of the first trimester. However, this risk does not appear to be associated with a single, low dose of fluconazole (150 mg) to treat vaginal yeast infection.

Birth defects include short, broad head, abnormal looking face, abnormal development of the skullcap, oral cleft (opening in the lip or palate), bowing of the thigh bones, thin ribs and long bones, muscle weakness and joint deformities, and congenital (present at birth) heart disease.

Based on this information, the pregnancy category for fluconazole indications (other than vaginal yeast infection) has been changed from category C to category D. The pregnancy category for a single dose of fluconazole 150 mg to treat vaginal candidiasis has not changed and remains category C.

Pregnancy category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite its risks.

Healthcare professionals should be aware of the potential risks with long-term, high-dose use of fluconazole and counsel patients if the drug is used during pregnancy or if a patient becomes pregnant while taking the drug.

For more on medical safety issues, see the library of articles by Daytona Beach child injury attorney.



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