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The FDA added a boxed warning to propylthiouracil to include information on reports of severe liver injury and acute liver failure, of which some have been fatal, in both adult and pediatric patients.
Propylthiouracil is used to reduce thyroid hormone levels and to decrease symptoms associated with hyperthyroidism, but is not recommended for use in pediatric patients except in rare instances where other treatments are not appropriate.
The new warning states that, "for those 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." However, propylthiouracil may be the treatment of choice before and during the first trimester of pregnancy due to the occurrence of birth defects observed with methimazole (Tapazole, King Pharmaceuticals).
To better understand the potential for liver injury with propylthiouracil, the FDA conducted a search of postmarketing adverse event reports for propylthiouracil submitted to the agency from 1969 to June 2009. In June 2009, the FDA issued a communication to health care professionals about severe liver injury associated with...