AR: In a new boxed warning, FDA is reminding healthcare professionals about the risk of serious liver injury, including liver failure and death, from propylthiouracil. This drug, which is used to treat hyperthyroidism, is considered second-line therapy when compared with methimazole, another anti-thyroid drug that poses less risk of liver damage.
MB: The new warning highlights that propylthiouracil should be reserved for patients who cannot tolerate methimazole, or radioactive iodine or surgery. But, propylthiouracil may be the drug of choice during the first trimester of pregnancy, since methimazole has been associated with birth defects. Propylthiouracil is not recommended for children, except in rare instances where other treatments aren't appropriate.
AR: Patients receiving propylthiouracil should be told about the possibility of liver damage, and should be instructed to promptly report symptoms such as fever, loss of appetite, nausea, tiredness, dark urine, or yellowing of the skin or eyes. A Medication Guide containing this information must be given to every patient filling a prescription for this drug.

标题
Liver Injury with Propylthiouracil (FDA)

视频介绍
FDA Patient Safety News - June, 2010 - Show #99
In a new boxed warning, FDA is reminding healthcare professionals about the risk of serious liver injury, including liver failure and death, from propylthiouracil.

Speaker #1: Anita Rayner (AR), Associate Director, Policy & Communications, U.S. Food and Drug Administration

Speaker #2: Mark Barnett (MB), Assistant Director, Education & Communication, U.S. Food and Drug Administration