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FDA Withdraws Approval for ADHD Drug

October 25, 2005

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The Food and Drug Administration (FDA) has withdrawn its approval for Cylert and its generic equivalent, pemoline, used to treat hyperactivity. The agency said the risk of liver damage and possible death outweighs any benefits of the drug.

Cylert is a central nervous system stimulant used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

In May 2005, Abbott, the drug's developer, chose to stop sales and marketing of Cylert in the U.S. Generic companies have now agreed to stop sales and marketing of related products, including pemoline tablets and chewable tablets.

FDA is not recalling the drug and pharmacies will be allowed to sell their remaining stock, allowing doctors time to switch patients to alternative treatments.

The consumer advocacy group Public Citizen called the lack of a recall "reckless and insensitive to the health and lives of children and adults using this drug." It said there should be an immediate recall of all remaining stocks of the drug.

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