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| April 21, 2010 |
FDA Drug Safety Communication:
New Boxed Warning on severe liver injury with propylthiouracil
Dear Colleague:
The United States Food and Drug Administration (FDA) has added a Boxed Warning to the label for propylthiouracil, a drug used to treat hyperthyroidism, 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 such as methimazole, radioactive iodine or surgery. In addition, due to the occurrence of birth defects that have been observed with the use of methimazole during the first trimester of pregnancy, propylthiouracil may be the treatment of choice during and just before the first trimester of pregnancy.
For additional information for healthcare professionals, including the data summary, please visit FDA's website at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm209023.htm
Sincerely,
Janelle Derbis, PharmD
Office of Special Health Issues
Food and Drug Administration
Janelle.Derbis@fda.hhs.gov
