Information Update

2006-91
September 21, 2006
For immediate release

New Information Regarding Uncommon Psychiatric Adverse Events For All ADHD Drugs

OTTAWA - Health Canada is informing Canadians that the prescribing and patient information for all drugs used for the management of ADHD (Attention Deficit Hyperactivity Disorder) is being revised to provide information about the potential for psychiatric adverse events, including rare reports of agitation and hallucinations in children.

This update comes in light of an ongoing review of psychiatric events associated with the use of these drugs and follows Health Canada’s May 2006 Public Advisory regarding rare heart-related risks for all ADHD drugs. At that time, Canadians were advised not to use ADHD drugs if they have high blood pressure, heart disease or abnormalities, hardening of the arteries or an overactive thyroid gland. Standardized labeling that identified risk factors for rare heart-related side effects, and new recommendations to physicians were added to the prescribing information for all ADHD drugs.

ADHD drugs are generally safe and provide benefits for Canadians in their treatment of ADHD when used as directed. Decisions about taking any of these drugs indicated for ADHD should be made in consultation with a physician.

Patients taking ADHD drugs should consult with their physician if they have any questions or concerns.

Health Canada continues to monitor the safety of ADHD drugs and Canadians will continue to be informed if new safety information arises. These drugs include Adderall XR, Attenade, Biphentin, Concerta, Dexedrine, Ritalin, Ritalin SR and Strattera.

For more current information on ADHD prescribing and patient information, see Health Canada’s Public Advisory regarding New Cautions Regarding Rare Heart-Related Risks for All ADHD Drugs.

-30-

Media Inquiries:
Paul Duchesne
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709