(2000; 18 pages)
Pemoline (Cylert®) - Withdrawn from the market
Canada. The Therapeutic Products Programme (TPP), Health Canada, recently conducted a benefit-risk assessment of the use of pemoline in the treatment of attention deficit hyperactivity disorder. The assessment concluded that the risk of serious liver complications, including liver failure necessitating transplantation or resulting in death, outweighs the benefits of continued use. As a result the drug was removed from the market on 30 September 1999. This conclusion was based on a number of considerations, the most important of which were:
(a) despite explicit warnings in the product monograph and labelling information regarding the risk of severe liver damage, worldwide case reports of liver failure necessitating transplantation or resulting in death continued to be received;
(b) there is no evidence that liver damage caused by the drug is predictable or reversible;
(c) other safer treatment alternatives are available; and
(d) a satisfactory response to the TPP's request for specific evidence to support the safety of the drug's continued use was not provided by the manufacturer.
Reference: Canadian Adverse Drug Reaction Newsletter, Vol 10, No 1, January 2000.