Advisory

1999-113
September 22, 1999

Liver complications result in withdrawal of Attention Deficit Hyperactivity Disorder drug Cylert

OTTAWA - Health Canada is advising patients, and the parents of patients, who are using the drug Cylert (pemoline) to contact their physicians as soon as possible to discuss alternative treatments, due to the rare possibility of serious liver complications. It is important, however, that patients NOT stop taking the drug until they have discussed the matter with their doctor.

Cylert (pemoline) is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and in adults. It is used together with other therapies to manage the behavioural symptoms of ADHD, such as short attention span and hyperactivity.

Cylert (pemoline) is a prescription drug, manufactured by Abbott Laboratories and dispensed as grooved, monogrammed tablets in two dosages. Tablets of 37.5 mg of pemoline are orange in colour, those of 75 mg of pemoline are tan. The manufacturer is recalling this product and it will be withdrawn from pharmacies on September 30, 1999.

To date, 16 cases of severe adverse liver effects that may possibly be associated with this drug have been reported worldwide.

There are alternative drugs available which are safe and effective in the treatment of ADHD. Nevertheless, the drug will continue to be available with restrictions through the Special Access Programme (SAP) of Health Canada. Health Canada will continue to evaluate new safety data as it emerges through the Programme and through worldwide reports.

The manufacturer of the drug, Abbott Laboratories, in consultation with Health Canada, has sent a letter to Canadian physicians and pharmacists to inform them that the drug will be withdrawn from sale. Since adverse effects on the liver may not become evident for months, the letter also advises doctors that it is important to continue monitoring liver function in those rare cases where patients may continue to obtain Cylert through the SAP.

Media inquiries:
Reva Berman
Health Canada
(613) 957-1588

Public Inquiries:
(613) 957-2991