Health Canada pulls ADHD drug off the market

http://www.healthsentinel.com/news.p...st_item&id=605

"Health Canada pulls ADHD drug off the market", CTV.ca, February 10,
2005,
Link:
http://www.ctv.ca/servlet/ArticleNew...hub=TopStories

Health Canada has ordered a drug for attention deficit hyperactivity
disorder be taken off the shelves after learning it has been linked to
20 sudden deaths and 12 strokes.

The drug in question is Adderall XR. It's made by Shire Biochem Inc.
and was approved for sale in Canada just over a year ago.

Health Canada is asking people taking the drug or parents of children
on it to consult their physicians immediately to select alternatives.

As well, manufacturers of other related drugs for ADHD have been asked
by Health Canada to provide a thorough review of their worldwide safety
data.

People taking related ADHD drugs should not stop their treatment but
could consult their doctors if they have concerns, the department said.

None of the deaths or strokes associated with Adderall XR were reported
in Canada, said department spokesman Ryan Baker.

But he noted the agency has received eight reports of adverse reactions
ranging in severity from convulsions to minor skin rash. "It's not been
determined yet whether these reactions were a result of Adderall XR
use,'' he said.

Shire's chief executive, Matthew Emmens, said in a statement late
Wednesday that the company "remains confident in the safety and
efficacy" of the drug. The company also said it "strongly disagrees
with the conclusions drawn by Health Canada.''

Of the 20 cases of sudden death linked to the drug, 14 were in
children. Two of the 12 strokes were suffered by children taking the
drug.

Dr. Robert Peterson, director general of the Therapeutic Products
Directorate noted that most of the victims had had no history of
cardiac problems before their sudden deaths.

He also noted that the deaths occurred in patients who were taking the
prescription as directed, within the recommended dosage levels.

Adderall is a stimulant within the amphetamine family. Peterson says
the mechanism by which the drug causes adverse effects is not yet known
but will be the subject of further investigation.

Health Canada began a review the drug's safety data in November 2004
following international reports of adverse reactions. They also chose
to conduct a preliminary review of safety data for the other related
drugs for ADHD treatment in Canada.

In the U.S., a related immediate-release form of the drug, called
simply Adderall, is also available. But it has never been approved for
sale in Canada.

The U.S. Food and Drug Administration said it had evaluated the same
reports as Health Canada but doesn't believe the data warranted the
same action in the United States.

"At this time, FDA cannot conclude that recommended doses of Adderall
can cause sudden unexplained death, but is continuing to carefully
evaluate these data,'' the agency said on its website.