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Endocrine Society endorses recommendation to stop using propylthiouracil in children
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The Endocrine Society has released a statement endorsing the recommendation that propylthiouracil not be used as first-line treatment for children with Graves’ disease because of concerns about potential severe liver disease.
The society released the statement after Scott A. Rivkees, MD, director of the Yale Child Health Research Center at Yale University School of Medicine, and Donald R. Mattison, MD, senior advisor at Eunice Kennedy Shriver National Institute of Child Health and Human Development, wrote a letter to the editor highlighting concerns of propylthiouracil use that was published in the April 9, 2009 issue of The New England Journal of Medicine.
It is estimated that 4,000 children are treated for Graves’ disease in the United States each year, and 40% are treated with propylthiouracil.
“Over the past 60 years, reports of propylthiouracil-related liver failure and death have accumulated,” Rivkees and Mattison wrote.
Based on several lines of evidence and frequency estimates, some presented at the Eunice Kennedy Shriver National Institute of Child Health and Human Development Hepatic Toxicity Following Treatment for Graves’ Disease workshop in October 2008, Rivkees and Mattison suggest that propylthiouracil no longer be used as first-line treatment for Graves’ disease in the pediatric age range.
“The Endocrine Society endorses this recommendation. Despite the relative rarity of Graves’ disease in the young, children and adolescents account for as many as 13 of 42 cases of serious propylthiouracil-related liver failure reported to date in the medical literature and a similar disproportionate number of those requiring liver transplant for this indication between 1990 and 2002,” the society wrote in the statement.
First-line therapy for children with Graves’ disease typically includes propylthiouracil and methimazole (Tapazole, King Pharmaceuticals). If antithyroid drugs are unsuccessful, radioactive iodine and surgery are used. According to Rivkees and Mattison, there are no reports of liver failure or transplantation associated with methimazole in children.
“Even one excess death is too many if it can be prevented. The Endocrine Society, therefore, suggests that until data from more thorough prospective studies or peer-reviewed retrospective studies become available, it would seem reasonable to use methimazole preferentially in the pediatric population,” according to the statement.
For more information, visit The Endocrine Society website at www.endo-society.org.
Rivkees SA. N Engl J Med. 2009;360:1574-1575.