Propylthiouracil associated with increased risk of serious liver injury

FDA has notified healthcare professionals that there is a risk of serious liver injury, including liver failure or death, with the use of propylthiouracil in both adult and pediatric patients.

FDA has received 32 reports (22 in adult patients and 10 in pediatric patients) of serious liver injury in patients treated with propylthiouracil. Among the adult patients, 12 deaths and 5 liver transplants occurred; among the pediatric patients, 1 death and 6 liver transplants occurred.

Propylthiouracil is approved for the treatment of hyperthyroidism and is generally used as second-line therapy except in patients who are allergic to or intolerant of methimazole or in patients who are in their first trimester of pregnancy.

Healthcare professionals should closely monitor propylthiouracil-treated patients for symptoms and signs of liver injury, especially during the first 6 months of therapy.