Cylert, Generics Withdrawn From the Market

Yael Waknine

Disclosures

October 25, 2005

Oct. 25, 2005 — The U.S. Food and Drug Administration (FDA) and Abbott Laboratories, Inc., have notified healthcare professionals that pemoline (Cylert and generic tablets and chewable tablets) will no longer be sold or marketed due to the risk of liver failure associated with its use.

The FDA is not recalling the drug and will allow pharmacies to sell remaining stock as patients transition to alternative therapies, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting system. Pemoline is indicated as second-line therapy for attention deficit — hyperactivity disorder (ADHD).

Abbott ceased production of the drug in May 2005, citing declining sales. Generic versions will now also be discontinued.

The FDA has received 13 reports of pemoline-associated hepatic failure leading to liver transplantation or death, representing an incidence rate 10 to 25 times greater than that of the general population.

After 12 of these reports, the drug's safety labeling was revised in 1999 to include a boxed warning describing the risk of liver toxicity and restricting its use to second-line therapy. One new case of pemoline-associated hepatic failure has been reported since that time, despite an 80% decrease in use of the drug.

Given the availability of multiple other drug treatments for ADHD (including one nonscheduled and several once-daily products), the FDA has concluded that the risk of hepatic failure outweighs the potential benefits of pemoline therapy.

Adverse events related to the use of pemoline should be reported to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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