63 Years and 715 Days to the "Boxed Warning": Unmasking of the Propylthiouracil Problem
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Commentary 63 Years and 715 Days to the “Boxed Warning”: Unmasking of the Propylthiouracil Problem Scott A. Rivkees Yale Pediatric Thyroid Center, Yale University, 464 Congress Avenue, New Haven, CT 06520, USA Correspondence should be addressed to Scott A. Rivkees, [email protected] Received 10 June 2010; Accepted 14 June 2010 Copyright © 2010 Scott A. Rivkees. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 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). This safety advisory followed the collective actions of academic societies, medical publishers, the National Institutes of Health, and the FDA. Considering that surgery and radioactive iodine are the legitimate treatment options for Grave Disease (GD), and are now the preferred alternative therapy in individuals who developed toxic reactions to MMI, the use of PTU should now be limited to exceptional circumstances and pregnancy. Long-term PTU therapy, especially in children, is not justifiable. The current advisory comes 63 years after the introduction of PTU for clinical use in 1947.
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—ending 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 mer
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