Health Canada will allow Shire BioChem Inc., the manufacturer of Adderall XR, to resume sales of the drug on the Canadian market following the recommendation of an independent and external committee appointed under the Food and Drugs Act.

The committee, known as a New Drug Committee (NDC), reviewed the suspension of the sale of Adderall XR, a drug used for the management of Attention Deficit Hyperactivity Disorder (ADHD). The suspension took place on February 9, 2005 due to safety information concerning possible sudden deaths, heart-related deaths, and strokes in children and adults taking regular recommended doses of Adderall and Adderall XR.

The NDC reviewed the information on which Health Canada based its decision earlier this year and concluded that the Department's actions were appropriate. The NDC made a number of recommendations in its review and Health Canada has accepted them all. The NDC's recommendations will be available on the Health Canada website in the coming days.

The committee also recommended that Shire BioChem Inc. distribute a letter to healthcare professionals to inform them about risks associated with use of the product. In addition, the committee recommended that the manufacturer support independent continuing medical education for Canadian physicians to reinforce their understanding of the issues around sudden/cardiac death in the paediatric population.

Also, in line with the committee's recommendations, Health Canada is enhancing post-market surveillance of all stimulant drugs used in the management of Attention Deficit Hyperactivity Disorder. Specifically, Health Canada will request that Shire BioChem Inc. provide safety information to Health Canada on a regular basis.

Under Food and Drug Regulations, when a drug is withdrawn from the market under article C.08006 of the Food and Drug Act, as was the case with Adderall XR, drug manufacturers have the option of requesting the appointment of a New Drug Committee to review Health Canada's decision. The committee was comprised of three independent experts in the areas of paediatric cardiology, paediatric development and behavioural problems, and pharmacoepidemiology.

Adderall XR, a central nervous system stimulant, was approved in Canada on January 23, 2004. Adderall, the immediate-release form of the drug, has never been marketed in Canada.