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PUBLIC ADVISORY - Health Canada Important Safety Information on ADDERALL XR(R)

Health Canada suspends the market authorization of ADDERALL XR(R), a drug prescribed for Attention Deficit Hyperactivity Disorder (ADHD) in children

Feb 9, 2005 | Health Canada

Health Canada is informing Canadians that
it has instructed Shire BioChem Inc., the manufacturer of ADDERALL XR(R) to withdraw the drug from the Canadian market. Health Canada has suspended the market authorization of the product due to safety information concerning the association of sudden deaths, heart-related deaths, and strokes in children and adults taking usual recommended doses of ADDERALL(R) and ADDERALL XR(R). The immediate release form of ADDERALL(R) has never been marketed in Canada.

Health Canada is advising patients who are currently being treated with ADDERALL XR(R) to consult their physician immediately about use of the drug and selecting treatment alternatives.

Health Canada's decision comes as a result of a thorough review of safety information provided by the manufacturer, which indicated there were 20 international reports of sudden death in patients taking either ADDERALL(R) (sold in the United States, not in Canada) or ADDERALL XR(R) (sold in Canada).

These deaths were not associated with overdose, misuse or abuse. Fourteen deaths occurred in children, and six deaths in adults. There were 12 reports of stroke, two of which occurred in children. None of the reported deaths or strokes occurred in Canada.

A preliminary review of safety data for the other related stimulants authorized for use in the treatment of ADHD in Canada has been conducted. In that review, the incidence of serious adverse reactions leading to death was higher in ADDERALL(R) and ADDERALL RX combined than in the other drugs of this class.

Health Canada has asked manufacturers of other related stimulants approved for the treatment of ADHD to provide a thorough review of their
worldwide safety data. Information updates will be provided by Health Canada as they become available.

Patients taking drugs of the same class for the management of ADHD should NOT discontinue their medication, and should consult with their physician if they have any concerns or questions.

ADDERALL XR(R), a Central Nervous System (CNS) stimulant, was approved in Canada on January 23, 2004 for the management of Attention Deficit Hyperactivity Disorder (ADHD) in children.

After having consulted with their physician, consumers should not flush unused drugs down the toilet or sink to avoid contaminating ground or municipal water systems but return any unused product to their pharmacy.

Health Canada has been in contact with Shire BioChem Inc., and will be monitoring the removal of this product from the Canadian market.

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