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Severe hepatotoxicity, vasculitis linked to propylthiouracil in young people
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Reports of severe hepatotoxicity and vasculitis were higher than expected in children and adolescents taking propylthiouracil compared with methimazole, according to a review of the safety profiles of both antithyroid drugs in the FDA Adverse Event Reporting System.
Scott A. Rivkees, MD, professor of pediatrics at Yale University, and Ana Szarfman, MD, PhD, medical officer at the FDA’s Center for Drug Evaluation and Research, analyzed more than 40 years of safety data collected in the Adverse Event Reporting System. They used a multi-item gamma-Poisson shrinker data mining algorithm to calculate adjusted observed ratios of drug-related adverse events in the system.
“Although the primary focus of our report was liver injury, a major vasculitis safety signal associated with propylthiouracil use in children and adolescents was observed,” the researchers wrote. “Vasculitis associated with methimazole use was also observed, but strength of association scores were lower than those observed for propylthiouracil.”
The algorithm identified more cases of severe hepatotoxicity in all age groups treated with propylthiouracil, especially pediatric patients, but not with methimazole. The calculated adjusted observed to expected ratio was 17 among people aged younger than 17 years.
“There are far fewer reports of death and less serious adverse events reported for methimazole than propylthiouracil in general,” the researchers wrote. “Our observations support the recommendations that propylthiouracil use should be avoided, especially in the pediatric population.”
Rivkees SA. J Clin Endocrinol Metab. doi:10.1210/jc.2009-2546.
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