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20 Adderall Deaths not enough to withdraw it ... says FDA



 
 
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  #1  
Old February 11th 05, 05:49 AM
Ilena Rose
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Default 20 Adderall Deaths not enough to withdraw it ... says FDA

I wonder how many will be enough?


http://www.bloomberg.com/apps/news?p...d=axaZ7aWJXXys


FDA Says Adderall Drug Data Isn't Enough for Recall (Update1)

Feb. 10 (Bloomberg) -- U.S. drug safety reports linking an attention
deficit drug to 20 deaths aren't enough for the Food and Drug
Administration to follow Canada in taking the product off the market,
the agency's director of medical policy said today.

Health Canada ordered the withdrawal yesterday of Adderall XR, made by
Shire Pharmaceuticals Group Plc, based on its review of adverse-event
reports previously given to the U.S. agency by the Basingstoke,
England-based company. The drug is prescribed for children and adults
with attention deficit hyperactivity disorder.

``The cases are not convincing evidence the drug is clearly
responsible for these deaths,'' said Robert Temple, director of the
FDA's office of medical policy, in an interview.

The drug, Shire's biggest product, will remain available in the U.S.,
its largest market, Temple said. House and Senate committees have been
probing the FDA's monitoring of drug safety since antidepressants were
linked to increased risk of suicide in children and Merck & Co.
withdrew its Vioxx painkiller after a company study tied it to heart
risks.

The FDA is deciding whether to conduct its own study of the Shire
drug's safety and will closely monitor adverse-event reports, Temple
said. In the U.S. about 2 million children have attention deficit
hyperactivity disorder, according to the National Institutes of
Health.

Shares of Shire, the U.K.'s third-biggest drugmaker, fell the most in
a more than a year today. The company's stock dropped 64.5 pence to
577.5 pence at the close of trading in London. The 10 percent drop was
the steepest since January 2003.

FDA Discouraged Withdrawal?

``Information conveyed to my staff suggests that during a recent
Adderall meeting, one or more FDA employees requested that the
Canadian government refrain from suspending the use of Adderall XR
because there was concern that FDA could not handle another `drug
safety crisis,''' Senate Finance Committee Chairman Charles Grassley,
an Iowa Republican, said today in a letter to acting FDA Commissioner
Lester Crawford.

Grassley requested details of meetings with Canadian officials
concerning Adderall and related records and documents. A phone message
left after normal business hours for FDA spokesman Brad Stone for
comment on Grassley's letter wasn't immediately returned.

Health Canada ordered the drug to be withdrawn after Shire declined a
request to take it off the market voluntarily, said Robert Peterson,
head of the agency's therapeutic products division, on a conference
call today with reporters. Canadian authorities will further examine
details of the safety reports before deciding whether to allow sales
to resume, Peterson said.

Amphetamine, Competitors

Adderall XR, the drug's extended-release version, had third- quarter
sales of $140 million, more than 40 percent of Shire's revenue for the
period. Adderall is an amphetamine, a class of drugs that stimulate
the central nervous system.

Shire ``is confident in the safety of Adderall XR,'' and disagrees
with Health Canada's conclusions, Shire spokesman Matthew Cabrey said
in a telephone interview. About 37 million prescriptions have been
dispensed over 10 years, and more than 1 million people have taken
Shire's two forms of Adderall, he said.

The Shire drug competes with Novartis AG's Ritalin, Johnson &
Johnson's Concerta, and Eli Lilly & Co.'s Strattera, which carries the
FDA's strongest-possible warning for risk of liver damage.

Reports of deaths among children and adults using Adderall XR led the
FDA in August to add a warning to the drug's label citing a risk of
sudden death and serious heart problems.

Both agencies' decisions were based on information the company gave
the FDA through the agency's adverse-event reporting system. The
reports linked the drug to the deaths of 14 children and six adults
from 1999 to 2003.

Complicating Factors

``Our conclusion now isn't any different from our conclusion when we
looked at them last time,'' the FDA's Temple said. ``What we found was
that the data were not convincing.''

Among the deaths, five patients had structural heart abnormalities,
one was a child with Type-1 diabetes, another was a child who had
exercised to the point of severe dehydration and heat exhaustion, and
an eighth showed toxic levels of amphetamine, according to a public
health advisory posted in the FDA Web site.

``This highlights that all medicines have their problems,'' said Mark
Stein, a professor of psychiatry and pediatrics at the University of
Chicago. ``It's really important that children be evaluated first to
make sure they don't have any cardiac abnormalities or anything else
that would put them at high risk.''

Sudden Deaths

The rate of deaths may not be significantly higher than among those
who don't use Adderall, Temple said. There have been seven reports to
the FDA of sudden deaths among patients using Ritalin or Concerta, he
said.

``It's not a favor to the community to react to everything that comes
out,'' Temple said. ``The decision to put a child on a chronic drug
should be made with full understanding that drugs are not risk-free.
You have to weigh all the benefits against the possibility the drug
could do something bad.''

Adderall's label in the U.S. already carries the strongest FDA
warning, highlighted in a black box, that amphetamines ``have a high
potential for abuse'' and ``should be prescribed or dispensed
sparingly.'' Separate warnings on the label caution against use during
pregnancy or while breast feeding.

The FDA's ``ability to inform people doesn't work,'' Representative
Bart Stupak, a Michigan Democrat, said in an interview today. Stupak
has been a critic of the FDA for several years after his son committed
suicide in 2000 while taking the acne drug Accutane, made by Roche
Holding AG. ``If you're going to keep this thing on the market, have a
signed informed-consent for the patient, and make it mandatory,''
Stupak said.

The House Energy and Commerce Committee will hold a hearing in March
to review how the FDA has regulated Accutane and other drugs, Stupak
said.



To contact the reporters on this story:
Geraldine Ryerson-Cruz in Washington at ;
Juliann Walsh in Princeton at
.

To contact the editor responsible for this story:
Robert Simison at


Last Updated: February 10, 2005 17:50 EST
  #2  
Old February 19th 05, 12:09 AM
MrTweezy
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Default

It's silly to even make an issue out of this.

  #3  
Old February 19th 05, 04:55 PM
Mark Probert
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"MrTweezy" wrote in message
lkabouthealthnetwork.com...
It's silly to even make an issue out of this.



Why?



 




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