News Flash

Important Boxed Warning for Propylthiouracil (PTU)

The FDA has issued a new boxed warning for propylthiouracil (PTU), also known by the brand name
Propyl-Thyracil, used to manage hyperthyroidism associated with Graves Disease.

The warning notes the risk of severe liver injury and acute liver failure in adult and pediatric patients.

Reports by the FDA suggest that the use of PTU carries more hepatotoxicity (liver damage) risk than the use of methimazole. Propylthiouracil should not be used in pediatric patients unless the patient is allergic to or intolerant of methimazole, and there are no other treatment options available.

Patients on PTU therapy should be closely monitored for symptoms and signs of liver injury, especially during the first six months of using this product.

For more information, please read the complete MedWatch 2010 Safety Summary.