Propylthiouracil gains Boxed Warning

The FDA has added a Boxed Warning to the label for propylthiouracil, to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients using this medication. The new warning also states that for patients being started on treatment for hyperthyroidism it may be appropriate to reserve use of propylthiouracil for those who cannot tolerate other treatments (eg, methimazole, radioactive iodine, or surgery).

Propylthiouracil is indicated for the treatment of hyperthyroidism in Graves’ disease.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164162.htm.