Adderall Recalled

Apparently Canada has banned it, but the FDA has decided the data is insufficient to ban in the U.S. Here is an article I found online (but address is probably too long to click — try cutting and pasting):

http://www.bloomberg.com/apps/news?pid=10000082&sid=axaZ7aWJXXys&refer=canada

The reason the data is too limited in the US is because our FDA uses industry-led research to base its decisions upon. Stimulants, like other specific categories of medicine are off limits for large publically funded study in this country unless the pre-determined outcome fits the company line.

There have been more thana couple teens in this country who have died as a result of long-term use of stimulants at therapeutic levels. One case I recall in TX back in ‘98 involved a coroner who put on his death report that the death was due to cardiac arrest brought on by chronic use of amphetimines or cocaine (he was not informed the child had been taking Ritalin for several years). When his report was being filed he was ordered to change his finding. He refused and it was changed anyway. I never did hear what happened to him after that.

Not everyone who takes these medications will have a positive experience, and a small minority of kids will face very serious health consequences. We need full transparency in this so parents can make more fully informed consent decisions and doctors know what to look for as early indicators of those children who face serious risk, regardless of accuracy of diagnosis or efficacy of prescribed drug.

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 [email protected];
> Juliann Walsh in Princeton at [email protected].
>
> To contact the editor responsible for this story:
> Robert Simison at [email protected]
> Last Updated: February 10, 2005 17:50 EST

I am sorry to beat this horse to the ground. Perhaps my boy’s perseverance was handed down to him…

[quote=FDA Says Adderall Drug Data Isn’t Enough for Recall
> 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.

20 deaths that we know of. 20 deaths that were so blatantly obvious that Canadian Officials took notice.

> 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.

This is the pattern seen repeated over and over. Anecdotal evidence of risk causes industry to take action, and the FDA still won’t acknowledge the problem leaving patients and doctors at the mercy of the unknown.

> 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.

So the FDA openly admits now that they are more concerned with their professional esteem than in carrying out their primary mission?

> 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.

I think we could learn something from our cousins to the North.

> 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.

And why were these kids on this medication if they had pre-existing medical problems that should have precluded them taking amphetimines?

> 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.

This doesn’t prove that Adderall is completely safe, it shows that ALL stimulant medications carry similar risks.

> “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.”

The trouble is, too many doctors are ill-informed about these medications because the industry-friendly FDA drags their heels about putting out warnings and we certainly cannot count on those who manufacture and profit to shout loudly the adverse risks of their products.

> 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.”

But these medications are not used “sparingly”. They are given daily, sometimes twice, keeping the medication in the body as much as possible. They are used for years at a time, with dosages adjusted upwards as the child becomes acclimated to it.

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.

Amen.

Dad, glad someone was going to say exactly what I was thinking!
I also agree, that we should learn something from the Canadians…..”eh”