Today, the FDA warned doctors about risks of serious liver injury associated with the anti-thyroid drug propylthiouracil (PTU), used to treat Graves’ disease. Graves’ disease is an autoimmune disorder that causes the thyroid gland, which controls hormones that regulate metabolism, to become overactive.
Since 1968, the FDA has tracked 32 cases of serious liver injury linked to PTU use. Of the 22 adult cases, 12 resulted in death and five required liver transplants; of the 10 child cases, one resulted in death and six in liver transplants.
"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," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. If PTU therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy." –FDA
According to the FDA, PTU is used as a “second-line drug therapy,” except when patients are allergic to or contraindicated for methimazole, the preferred drug for treating Graves’ disease. Because methimazole has been shown to cause a rare birth defect not associated with PTU, PTU is often given to Graves’ disease patients during early pregnancy.
If you or a loved one has suffered liver injuries after using PTU, contact the Ferrara Law Firm to learn more about your right to compensation.