FDA Warns of Risk of Liver Failure and Death From Hyperthyroidism Drug

The Food and Drug Administration has just issued an urgent advisory about the risk of serious liver injury, including liver failure and death, associated with the use of the drug propylthiouracil (PTU) to treat hyperthyroidism caused by Grave’s disease.

The FDA has so far identified 32 cases of serious liver injury in both adults and children treated with PTU. There have been 22 reports of injury to adults and 10 incidents involving pediatric patients, the FDA said.

PTU is available only in generic form and is not sold under brand name labels, the FDA said. The agency has sent a letter to endocrine healthcare professionals, pharmacists, and pediatricians to warn them of the risks of hepatoxicity in patients being treated with PTU for hyperthyroidism caused by Grave’s disease.

Propylthiouracil carries a higher risk of injury compared to another hyperthyroidism drug, methimazole, the FDA said. Both drugs are approved for treating hyperthyroidism brought on by Grave’s disease, but doctors are being cautioned to carefully consider which drug should be prescribed to people newly diagnosed with Grave’s disease.

Grave’s disease is an autoimmune disease where causes patients’ own antibodies to attach to thyroid stimulating hormone receptors within cells of the thyroid gland, triggering overproduction of thyroid hormone.

Patients taking PTU should be closely monitored for signs of liver injury, particularly in the first six months of treatment, the FDA said. PTU should only be used in pediatric patients who are allergic or intolerant to methimazole and no other effective treatments are available, the agency said.

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