ADDERALL WITHDRAWN by Canada regulators

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Canadian regulators order attention-deficit drug

withdrawn after reports of deaths, strokes

Thursday, February 10, 2005

ASSOCIATED PRESS

http://www.freep.com/news/latestnews/pm2758_20050210.htm

TORONTO - Canadian regulators ordered a drug for attention deficit hyperactivity

disorder pulled off the market because of reports that it has been linked to 20

sudden deaths and a dozen strokes, including some among children.

Health Canada said late Wednesday that it is asking makers of related stimulants

used to treat the commonly diagnosed condition to provide a thorough review of

their worldwide safety data.

None of the deaths or strokes associated with Adderall XR, made by Basingstoke,

England-based Shire Pharmaceuticals Group PLC, were reported in Canada,

department spokesman Baker said.

" 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.

Shire shares fell 10.5 percent to 574.5 pence in trading on the London Stock

Exchange.

The drug is sold in Canada and the United States. A related immediate-release

form of the drug, sold simply as Adderall, is sold in the United States but has

not been approved for sale in Canada, where 11,000 patients are prescribed

Adderall XR. Canadian officials approved that drug in January 2004.

Shire's chief executive, Emmens, said in a statement late Wednesday that

the company " remains confident in the safety and efficacy " of the drug.

The U.S. Food and Drug Administration said it had evaluated the same reports as

Canadian regulators and doesn't believe the data warranted such action in the

United States.

Emmens said the FDA reviewed the same data as Health Canada last year and sought

an additional warning in September that the drug should not be prescribed for

people with " structural cardiovascular abnormalities. "

About 700,000 people take Adderall XR in the United States, with about 300,000

more using Adderall, Shire spokesman Cabrey said. Shire reported $140

million in U.S. sales of the drugs in the third quarter of 2004.

In a statement posted on its Web site late Wednesday, the FDA said it " 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. "

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