The Food and Drug Administration (FDA) has issued an alert (http://bit.ly/15OIVo) notifying health care providers of the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil, a long-standing treatment for hyperthyroidism associated with Graves' disease. The warning is based on 32 case reports of 22 adults and 10 children-12 of the adults died and five needed liver transplantation; one of the children died and six needed liver transplantation.

Although propylthiouracil is considered a second-line drug therapy for Graves' disease (methimazole [Tapazole, Northyx], another antihyperthyroid agent, is considered first-line drug therapy), it may be used as first-line drug therapy in women in the first trimester of pregnancy because it hasn't demonstrated an association with embryopathy, an adverse effect reported with the use of methimazole.

The FDA recommends that propylthiouracil treatment should be restricted to adult patients who are allergic to or intolerant of methimazole and to pregnant women in the first trimester. Further, the agency recommends that propylthiouracil be used in pediatric patients only if they're allergic to or intolerant of methimazole and no other treatment options are available. Patients taking propylthiouracil should be closely monitored for signs and symptoms of liver injury. In this case, the drug should be discontinued, appropriate evaluation performed, and supportive care provided. In addition, patients should be instructed to look for signs of liver complications (fatigue, weakness, abdominal pain, diminished appetite, easy bruising, yellowing of the eyes or skin, and itching), and to promptly seek medical attention if these symptoms develop.