Re: Canada Regulators Order ADD Drug Withdrawn

[Guest guest]

I have two students on this crap. I am bringing this to school.

Thanks

Casey

> February 10, 2005

> Canada Regulators Order ADD Drug Withdrawn

> By THE ASSOCIATED PRESS

>

> Filed at 12:02 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 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, 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 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.