FDA warns of hepatotoxicity risk with propylthiouracil (PTU)

The FDA has notified healthcare professionals of the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil (PTU) in adult and pediatric patients. The FDA has received reports suggesting an increased risk of hepatotoxicity with PTU when compared to methimazole. The FDA has identified 32 cases (22 adult and 10 pediatric) of serious liver injury associated with PTU use. Of the adult cases, 12 deaths and 5 liver transplants occurred. Among the pediatric patients, 3 deaths and 6 liver transplants occurred.

Physicians should closely monitor patients on PTU therapy for signs and symptoms of liver injury, especially during the first six months after initiation. PTU should not be used in pediatric patients unless the patient is allergic to or intolerant of methimazole and there are no other treatment options available.

Propylthiouracil and methimazole are both indicated for the treatment of hyperthyroidism in Graves’ disease.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164162.htm.