Canadian Regulators Withdraw ADD Drug Linked to 20 Sudden Deaths

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[sSRI-Research] Canadian Regulators Withdraw ADD Drug Linked

to 20 Sudden Deaths

 

 

 

 

 

Canadian Regulators Withdraw ADD Drug Linked to 20 Sudden Deaths

 

http://www.ahrp.org/infomail/05/02/10a.php

 

Thu, 10 Feb 2005

 

Canadian regulators - but not the FDA - have withdrawn a Adderall, a

pssychostimulant drug prescribed for children with so-called ADHD that

has been linked to 20 sudden deaths linked to the drug - of which 14

were in children. " The adverse reactions were not associated with

overdose, misuse or abuse of the drug, the department said. "

 

Health Canada has requested that manufacturers of related stimulants.

 

Although the FDA reviewed the same data as Health Canada last year and

sought an additional warning applied only to people with 'structural

cardiovascular abnormalities.'

 

Health Canada, by contrast 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 discard unused

pills but rather to take them to a pharmacy for safe disposal. "

 

Once again, FDA officials are ignoring a lethal drug-linked effect and

standing by as children's lives are being put at risk by being exposed

to a potentially lethal drug prescribed for a medically dubious

Ocondition.'

 

Contact: Vera Hassner Sharav

212-595-8974

 

 

 

February 10, 2005

Canada Regulators Order ADD Drug Withdrawn

By THE ASSOCIATED PRESS

 

Filed at 9:04 a.m. ET

 

TORONTO (AP) -- Canadian regulators ordered a drug for attention

deficit hyperactivity disorder off the market late Wednesday because

of reports that it has been linked to 20 sudden deaths and a dozen

strokes, including some among children.

 

The U.S. Food and Drug Administration, however, said it had evaluated

the same reports and doesn't believe the data warranted such action in

the United States. In a statement late Wednesday, Health Canada said

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 were

reported in Canada, department spokesman 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 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 Pharmaceuticals Group PLC, based in

Basingstoke, England, 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 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.

 

Emmens said the FDA had 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 Matthew Cabrey said

Wednesday. 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.''

 

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 discard unused pills 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 the

class, the release said.

 

ADHD is the most commonly diagnosed psychiatric disorder among

school-aged children.

 

Copyright 2005 The Associated Press

 

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