Canada Regulators Order Top-Selling ADD Drug
Withdrawn.
Canada pulled the top-selling ADHD drug Adderall XR, citing the
sudden death of some patients. Adderall XR was pulled off Canadian
shelves Wednesday (Feb. 9, 2005) after Adderall manufacturer Shire
provided information about 20 sudden deaths in patients taking
this popular ADHD medication.
"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,” the
Canadian health department said in a statement released yesterday.
Adderall is linked to 20 deaths - 14 children and 6 adults.
Adderall is also linked to 12 strokes, two of which occurred in
children. The adverse reactions were not associated with overdose,
misuse or abuse of the drug, Health Canada said.
Of its decision to ban Adderall XR, Health Canada said the
incidence of serious, adverse reactions leading to death were
found to be higher in Adderall XR than other ADHD drugs.
Adderall XR is prescribed to about 11,000 Canadians. About 700,000
people take Adderall XR in the United States, with about 300,000
more using Adderall. Canadian officials approved Adderall XR in
January 2004. A immediate-release form of Adderall XR, sold simply
as “Adderall”, is not sold in Canada.
The FDA said it evaluated the same reports as Canadian regulators
but did not believe the data warranted a ban in the United States.
Instead of removing Adderall XR from US shelves, the FDA modified
Adderall XR use instructions, stressing that Adderall XR should
not be used in children or adults with heart defects.
In response to Health Canada’s withdraw of Adderall XR, the
following statement was posted on the FDA web site Wednesday; the
FDA "does not feel that any immediate changes are warranted in the
FDA labeling or approved use of this drug based upon its
preliminary understanding of Health Canada's analyses of adverse
event reports and FDA's own knowledge and assessment of the
reports received by the agency."
Shire officials "strongly disagreed" with Health Canada's actions.
"We continue to be confident in the safety and efficacy of
Adderall XR," said Shire spokesman Matt Cabrey.
Drug regulators across the world are taking an increasingly tough
stance on the safety of medicines following a number of
high-profile scandals. In September Merck withdrew Vioxx, a
popular arthritis painkiller, after clinical tests showed it
raised the risk of heart attacks.
The number of deaths caused by Adderall XR make up a very small
percent of people using the drug. However, if that one death is
you or someone you love, that fact is little consolation. Sudden
death is the worst
side
effect of Adderall, but certainly not the only one. This ADHD
medication news follows closely on the tail of news that links
Strattera to liver damage.
If you or someone you love is currently taking Adderall XR,
Strattera or other medication for Attention Deficit Disorder,
please consider
safe
alternatives.
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