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From the FDA: A Hyperthyroidism Drug Can Cause Severe Liver Injury and Failure

Propylthiouracil (PTU) is a drug used to treat hyperthyroidism (overactive thyroid). Recently, the US Food and Drug Administration (FDA) added a Boxed Warning to the drug’s label to inform consumers of potential severe liver injury, acute liver failure and possible death in patients using this medication. Also, the FDA now requires that a Medication Guide be given to every patient filling a prescription for the drug.

More information for patients:

• Patients should read the Boxed Warning and Medication Guide to understand the known benefits and potential risks of PTU.
• Contact your doctor if you have fever, loss of appetite, nausea, vomiting, tiredness, itchiness, dark colored urine or yellowing of your skin or eyes while taking PTU.
• Talk to your doctor if you are pregnant (or plan to become pregnant) and are taking a medication to treat hyperthyroidism. PTU may be your treatment of choice during the first trimester of your pregnancy.
• Tell your doctor about any medication you are taking or medical conditions you may have before taking PTU.
• Don’t stop taking PTU unless you are told to do so by your doctor.

More information for health care professionals:

• Patients being started on treatment for hyperthyroidism should take PTU only if they cannot tolerate other treatments such as methimazole, radioactive iodine or surgery.
• Due to the chance of birth defects with the use of methimazole during the first trimester of pregnancy, PTU may be the treatment of choice during and just before the first trimester of pregnancy.
• PTU is not recommended for use in pediatric patients, except in rare cases in which other treatments are not appropriate.

For more information about the new safety information in propylthiouracil’s drug label, please read all of the recommendations outlined by the FDA.