Canada — Health Canada is advising patients taking pemoline to contact their physicians as soon as possible to discuss changing to alternative treatments. The manufacturer has recalled this product which has now been withdrawn from pharmacies.
Pemoline is used to treat Attention Deficit Hyper-activity Disorder (ADHD) in children and adults together with other therapies to manage behavioural symptoms. To date, 16 cases of severe liver complications have been reported worldwide which may possibly be associated with this product.
Although alternative drugs exist which are safe and effective, the product will continue to be available through the special access programme, with instructions on liver function monitoring. Health Canada will evaluate new safety data as they become available.
Reference: Health Canada warning dated 20 January 2000. http://www.hc-sc,gc.ca