The FDA has reported on at least 32 cases of serious liver damage associated with the use of propylthiouracil in adults and children, including twelve deaths and five liver transplants in adults, and one death and six liver transplants in pediatric patients.
The FDA suggests that the use of propylthiouracil to treat hyperthyroidism due to Graves’ disease carries more hepatotoxicity (liver damage) risk than the use of methimazole.
Healthcare professionals should closely monitor propylthiouracil patients for signs of liver damage, including dark urine, yellowish eyes and elevated enzymes levels in the liver.
FDA is continuing to monitor these serious reported adverse events and working to make changes to the propylthiouracil prescribing information, particularly for use in pediatric patients. The American Thyroid Association (ATA) plans to update its treatment guidelines for Graves disease in response to these findings.