%0 Journal Article
%T 63 Years and 715 Days to the "Boxed Warning": Unmasking of the Propylthiouracil Problem
%A Scott A Rivkees
%J International Journal of Pediatric Endocrinology
%D 2010
%I BioMed Central
%R 10.1155/2010/658267
%X 715 days after potential problems related to PTU use in children were presented in a debate in front of the Lawson Wilkins Pediatric Endocrine Society (LWPES), the US Food and Drug Administration issued a black-box warning about the hepatotoxicity risk of the antithyroid drug propylthiouracil (PTU) [1].This safety advisory stated that "The United States Food and Drug Administration (FDA) has added a Boxed Warning to the label for propylthiouracil, a drug used to treat hyperthyroidism (overactive thyroid), 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." [1]. This safety advisory followed the collective actions of academic societies, medical publishers, the National Institutes of Health, and the FDA, all with the same goal¡ªending PTU-induced liver failure. This safety advisory comes 63 years after the introduction of PTU for clinical use for the treatment of hyperthyroidism in 1947.Three years ago, a perspective advocating surgery as the primary form of definitive therapy for children with Graves' disease (GD) was published in The Journal of Clinical Endocrinology and Metabolism (JCEM) along with a counterpoint commentary on the use of radioactive iodine in GD [2, 3]. The print discourse caught the attention of LWPES program planners.On May 4, 2008, at the annual meeting of LWPES, a "Great Debate" was held between Dr. Melvin Grumbach of the University of California, San Francisco and Dr. Scott Rivkees of Yale University, focusing on the merits of surgery versus radioactive iodine treatment. Beforehand, the discussants agreed to comment on the risks associated with antithyroid drugs. A slide was presented stating that "Anti-thyroid Medication use Should not be Viewed as Trivial in Children. We need a black-box warning".After the presentation and after the meeting, one of the discussants was made aware of what seemed to be a cluster of complication
%U http://www.ijpeonline.com/content/2010/1/658267