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Pemoline (Cylert and generic pemoline products) is a central nervous system stimulant currently prescribed for treatment of patients with ADHD. For many years, pediatricians have been concerned about the association between pemoline and severe liver toxicity and hepatic failure. Now, the FDA has concluded that the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug. All manufacturers have agreed to stop sales and marketing of this product.
Background: In 1999, the FDA issued a boxed warning and restrictive labeling for pemoline products. Since then, the prescription rate has decreased by 80%. At least 13 cases of pemoline-associated liver failure resulting in liver transplant or death …