Thyroid disease drug approved in 1947 could cause serious liver injury, FDA says

ROCKVILLE, Md. An anti-thyroid drug used to treat Graves’ disease could increase the risk of serious liver injury, the Food and Drug Administration said Wednesday.

The agency said 32 cases of serious liver injury associated with the use of propylthiouracil, also known as PTU and approved in 1947, were reported through its Adverse Event Reporting System between 1969 and October 2008. The 22 adult cases included 12 deaths and five liver transplants, while the 10 cases in children included one death and six 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,” FDA official Amy Egan said in a statement. “Healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease.”

Graves’ disease is an autoimmune disorder that leads to overactivity in the thyroid gland.