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Health Canada Orders ADHD Drug Off Market After Reports of Deaths, Strokes

Feb 9, 2005 | Canadan Press

Health Canada has ordered a once-a-day
treatment for attention deficit hyperactivity disorder off the market after learning the drug has been linked to 20 sudden deaths and 12 strokes, including among children.

And makers of related stimulants used to treat the
commonly diagnosed condition have been asked to
provide a thorough review of their worldwide safety data, Health Canada said in a release late Wednesday. None of the deaths or strokes associated with Adderall XR were reported Canada, said department spokesman Ryan Baker.

"However, Health Canada has received eight reports of adverse reactions ranging in severity from convulsions to minor skin rash," Baker said.

"It's not been determined yet whether these reactions were a result of Adderall XR use."

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. The adverse reactions were not associated with overdose, misuse or abuse of the drug, the department said.

The drug is made by Shire Biochem Inc. and is sold in Canada and the United States. A related
immediate-release form of the drug, sold simply as
Adderall, is sold in the U.S. but has never been
approved for sale in Canada.

Health Canada is asking people taking the drug or
parents of children on it to consult their physicians immediately to select alternatives. It is also asking them not to flush unused pills down a toilet or sink but rather to take them to a pharmacy for safe
disposal.

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

In light of the international reports of adverse
reactions, the department reviewed the drug's safety data and conducted a preliminary review of safety data for the other related stimulants authorized for treatment of ADHD in Canada.

The incidence of serious adverse reactions leading to death was higher in Adderall and Adderall XR combined than in any other drugs of this class, the release
said.

ADHD is the most commonly diagnosed psychiatric
disorder among school-aged children.


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