THURSDAY, June 4 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) has issued a warning about the risk of serious liver injury as a result of treating Graves' disease with the anti-thyroid drug propylthiouracil (PTU) after adverse reports concerning the drug were reported.
Graves' disease, an autoimmune disorder that causes the thyroid gland to become overactive, is treated with PTU as a second-line therapy in patients who are allergic to or intolerant of the first-line drug methimazole, or for women in the first trimester of pregnancy.
The FDA had received 32 adverse event reports concerning the drug from 1969 through 2008, of which 22 cases were among adults and 10 among children. There were 13 deaths, including one child, and 11 liver transplants, of which six were in pediatric patients.
"After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," says Amy Egan, M.D., of the FDA's Center for Drug Evaluation and Research, in a statement. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If PTU is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy.
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