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Health Canada Has Suspended Market Authorization of ADDERALL XRTM (amphetamine salts), A Drug Approved for Attention Deficit Hyperactivity Disorder (ADHD) In Children

Feb 9, 2005 | Health Canada

Health Canada advises you that marketing of the Attention Deficit Hyperactivity Disorder (ADHD) drug, ADDERALL XRTM (amphetamine salts) has been suspended effective February 9, 2005. ADDERALL XRTM, marketed by Shire BioChem Inc., is a prescription drug that was authorized in Canada for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children.

Health Canada's decision to withdraw ADDERALL XRTM is founded on very rare, international, spontaneous reports of sudden deaths, in paediatric and adult patients in association with ADDERALL® (immediate release) and ADDERALL XRTM (extended release). Reports for death include those for patients taking usual recommended doses, including recommended starting doses, of ADDERALL® and ADDERALL XRTM. In a minority of cases, the events occurred on the first day of dosing or shortly after an increase in dose or a switch from another drug in the structural class. Deaths were reported for patients both naïve or chronically exposed to amphetamine-related Central Nervous System stimulants. This decision was not based on reported deaths that were associated with overdose, misuse or abuse. Of the 20 reported deaths, there were cases that occurred in patients without a documented history of structural or other cardiac abnormalities/disease. In a few cases, other drugs, including anti-depressants, clonidine and/or anti-psychotics, were concomitant medications. Exercise was an associated event in some of the reports of death. None of the reported deaths occurred in Canada.

Health Canada is aware of 20 international reports of sudden death in patients taking either ADDERALL® (immediate release) or ADDERALL XRTM (extended release) with 3.45 million patient-years of exposure. 14 deaths occurred in children, and 6 deaths in adults. ADDERALL XRTM has been marketed in Canada since January 23, 2004, while the immediate release form of ADDERALL® has never been marketed in Canada.

A preliminary review of safety data for the other stimulants authorized for use in the treatment of ADHD in Canada has been conducted. The incidence of serious adverse reactions leading to death was higher in ADDERALL®/ADDERALL XRTM than in the other stimulants, based upon these reviews. In addition, the safety information submitted to Health Canada also included 12 reported cases of stroke, with 2 occurring in children.

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

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