ADD drug yanked from shelves</font>
Adderall XR linked to deaths, strokes</font>
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 spokesperson Ryan 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
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, Matthew
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 spokesperson Matthew 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 website late Wednesday, the FDA said it
"does not feel that any immediate changes are warranted in the FDA
labelling 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