Safety Alerts & Recalls

What does this mean?

This safety alert is based on the FDA's current analysis of the available adverse events reports concerning propylthiouracil. At this time, a definite relationship has not been determined between propylthiouracil and liver problems. The FDA will continue to monitor propylthiouracil adverse event reports and provide updates as additional information becomes available.

If you are taking propylthiouracil, you should follow up with your doctor to evaluate the benefits and risks of continuing to take this medicine - your doctor may want to measure your liver function and possibly change your medication. However, it may be appropriate to continue propylthiouracil in some patients, such as women in their first trimester of pregnancy, or patients who are allergic to or intolerant of methimazole, the other available hyperthyroid treatment.

If you continue to take propylthiouracil, your doctor will monitor your liver function tests routinely. Contact your doctor right away if you notice any of the following signs or symptoms: fatigue, weakness, vague abdominal pain, loss of appetite, itching, easy bruising or yellowing of the eyes or skin.

Risk of Serious Liver Injury From Propylthiouracil

The FDA has identified a possible increased risk of serious liver injury, including liver failure and death, with the use of propylthiouracil in adult and pediatric patients. Reports to the FDA's Adverse Event Reporting System (AERS) suggest there is an increased risk of liver toxicity with propylthiouracil when compared to methimazole. Both propylthiouracil and methimazole are indicated for the treatment of hyperthyroidism due to Graves's disease.

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Source: FDA
Publication Date: 2009-06-04
Last Updated: 2009-12-05

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