News Release

2005-92
August 24, 2005
For immediate release

Health Canada allows Adderall XR® back on the Canadian market

OTTAWA - 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.

In line with the committee's recommendation, Health Canada has agreed to reinstate the marketing authorisation for Adderall XR® with a number of revisions to the Adderall XR labelling. In particular, labelling will be revised to include warnings against the use of Adderall XR in patients with structural heart abnormalities. Another warning will advise about the dangers of misusing amphetamines.

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 pediatric population.

Also, in line with the committee's recommendations, Health Canada is committed to 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Under Food and Drug Regulations, when a drug is withdrawn from the market under article C.08006 of the Food and Drug Act, as was the case with Adderall XR®, drug manufacturers have the option of requesting the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 pediatric cardiology, pediatric development and behavioural problems, and pharmacoepidemiology.

Health Canada is advising patients to consult their physicians, who will be receiving additional information from Shire BioChem Inc., about use of the drug.

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.

Health Canada relies on the active participation of health care professionals in adverse reaction reporting programs. Cases of cardiac or other serious and/or unexpected adverse reactions in patients taking drugs of the same class should be reported to Health Canada at the following address:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 1 866 234-2345
Fax: 1 866 678-6789
cadrmp@hc-sc.gc.ca

For other inquiries: please refer to contact information.

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

Note: Health Canada issued another advisory on this topic on February 9, 2005. To access this advisory, visit:

www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/2005_01_e.html

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Media Inquiries:
Jirina Vlk
Health Canada
(613) 957-2988

Public Inquiries:
(613) 957-2991