Health
Canada On-line, February 9, 2005.
Ottawa, Canada.
Health Canada suspends the market authorization
of ADDERALL XR® , a drug prescribed for Attention Deficit Hyperactivity
Disorder (ADHD) in children
Health Canada is
informing Canadians that it has instructed Shire BioChem Inc., the manufacturer
of ADDERALL XR® 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® and ADDERALL XR®. The immediate release form
of ADDERALL® has never been marketed in Canada.
Health Canada is advising patients who are currently being treated with
ADDERALL XR® 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®
(sold in the United States, not in Canada) or ADDERALL XR® (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® 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®, 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.
