Propylthiouracil May Increase Risk for Serious Liver Injury

Adult and pediatric patients taking propylthiouracil (PTU) may be at increased risk for serious liver damage, including liver failure and death, the FDA announced on Wednesday. The drug is largely a second-line therapy for Graves hyperthyroidism.

The agency has tracked 32 cases of serious liver injury linked to PTU therapy. Thirteen patients died, and 11 required liver transplants.

The FDA advises clinicians to:

• use PTU only in patients who have an allergy or intolerance to methimazole, or in pregnant women in their first trimester;

• monitor patients on PTU for signs of liver damage, particularly during the first 6 months of therapy;

• have patients contact them if symptoms of liver injury occur, including fatigue, weakness, abdominal pain, itching, easy bruising, or yellowing of the eyes or skin;

• discontinue PTU use if liver damage is suspected.