Suspension
of Sales of Adderall XR in Canada
(February 2005)
Canada has requested the suspension
of sales of, Adderall XR (dextroamphetamine),
a medication used in the treatment
of attention deficit hyperactivity
disorder because of safety concerns.
The manufacturer has complied with
the request but “strongly disagreed
with the decision of the Canadian regulator,
Health Canada”
The FDA has been quick to respond
to this issue and is of the opinion
that a recall or suspension of sales
is not warranted in the United States.
The following is a direct quote from
the FDA:
Statement on Adderall
FDA is aware of Health
Canada’s decision to suspend
sales, but not revoke the approval
in Canada, of the drug Adderall
as a treatment for Attention
Deficit and Hyperactivity Disorder
(ADHD). FDA has been in close
consultation with the Canadian
authorities regarding the basis
for their action. 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.
FDA is issuing a Public Health
Advisory and information sheets
on its website at www.fda.gov in
order to address questions that
may arise from the Canadian announcement
and to provide up-to-date information
about Adderall’s safety
profile.
Patients using Adderall (or
parents of children on the drug)
who have questions about this medication
should consult their physicians
before making any alterations to
their therapy.
As with any drug, FDA will
continue to carefully assess any
new data that emerges which significantly
affects the safety profile of
this drug and will take immediate,
appropriate action to promote the
public health and make the public
aware of its findings.
The physicians at El Camino Pediatrics
and El Camino Successful Solutions
are of the opinion that this medication
is extremely useful and that unless
more information is presented to the
contrary, patients on Adderall and
Adderall XR should continue to fill
their prescriptions.
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Health
Update