Cylert and generic pemoline products

Pharmacies will be allowed to sell their remaining stock. Citizen called the lack of a recall reckless and insensitive to the health and lives of children and adults using this drug.

Audience: Neuropsychiatric healthcare professionals", default"/images/fda1.jpg" width="73" height="70">

Cylert and generic pemoline products

Pharmacies will be allowed to sell their remaining stock. Citizen called the lack of a recall reckless and insensitive to the health and lives of children and adults using this drug.

Audience: Neuropsychiatric healthcare professionals, Pediatricians, Pharmacists and consumers
[Posted 10/24/2005] FDA has concluded that the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug. In May 2005, Abbott chose to stop sales and marketing of Cylert in the U.S. All generic companies have also agreed to stop sales and marketing of this product. Cylert, a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), is considered second line therapy for ADHD because of its association with life threatening hepatic failure. Health care professionals who prescribe Cylert, or any of its generics, should transition their patients to an alternative therapy. Cylert will remain available through pharmacies and wholesalers until supplies are exhausted. No additional product will be available. 

[October 24, 2005 - Drug Information page - FDA] http://www.fda.gov/cder/drug/InfoSheets/HCP/pemolineHCP.htm
 

[December 2002 - Label - FDA]http://www.fda.gov/cder/foi/label/2003/016832s022_017703s018lbl.pdf

FDA Withdraws Approval for ADHD Drug

October 25, 2005
The Food and Drug Administration (FDA) has withdrawn its approval for Cylert and its generic equivalent, pemoline, used to treat hyperactivity.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.