Sudden Death in 12 Kids on ADHD Drug Adderall (Canada suspends it)

[wildflower]

Sudden Death in 12 Kids on ADHD Drug Adderall

Adderall XR Sales Suspended in Canada, FDA Issues U.S. Advisory

Feb. 10, 2005 - Twelve sudden deaths in American kids taking Adderall have led Canada to suspend sales of the drug.

Adderall is an amphetamine drug used to treat children and adults with ADHD -- attention deficit hyperactivity disorder. It's sold in the U.S. in an immediate-release form and, as Adderall XR, in an extended-release form.

The FDA is not following the lead of Health Canada, the Canadian drug regulatory agency. After seeing the same reports in August 2004, the FDA at that time merely agreed to a label change for Adderall XR. That change made it clear that Adderall XR should not be given to patients with heart defects.

"FDA 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," a Feb. 9 FDA statement says.

more at

http://my.webmd.com/content/article/100/105791.htm?z=3734_00000_1000_qd_01

[Lisabtrucking]

1. Thanks for the info, my doctor has just given me a prescription for

This drug to help me concentrate on things better. It's at the drug story right now being filled. I think I'll give her a call and ask her whats up with this.

I swear our government is trying to knock some of us off.
This is a scary time to see a doctor to begin with, now that you can't sue them.

[wildflower]

4. I just heard about this from Janeane Garofalo on AAR...

so I went and looked it up. Janeane said she's going to keep taking it anyway.

Good luck; I hope the doctor can give you the straight scoop, and if necessary, find something else that will work for you.

-wildflower

[BOHICA06]

5. You want a completely safe Speed?

I don't think that will ever be available - but your physician should at least brief you so you can make an informed risk & reward decision!

[HysteryDiagnosis]

2. PubMed

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11772303

1: Expert Opin Investig Drugs. 2001 Nov;10(11):2003-11. Related Articles, Links
Click here to read
SLI381: a long-acting psychostimulant preparation for the treatment of attention-deficit hyperactivity disorder.

Grcevich S.

Division of Child and Adolescent Psychiatry, University Hospitals of Cleveland, Cleveland, OH, USA.

SLI381 (Adderall-XR) is a longer-acting form of Adderall, a compound of mixed amphetamine salts that is now the most frequently prescribed brand of psychostimulant medication for attention-deficit hyperactivity disorder (ADHD) in the US. It has been demonstrated to be a safe and effective treatment for ADHD in school-age children. To date, the efficacy of SLI381 has been evaluated in controlled studies of over 500 patients. The therapeutic effects of SLI381 on the core symptoms of ADHD, as well as the duration of action of the formulation, have been demonstrated to persist for 12 h, with both greater efficacy and duration of effects seen at higher doses. Both behavioural and cognitive performance measures are improved throughout the school day and into post-school activities. The incidence of common stimulant-emergent side effects with SLI381 was no different than that seen with the existing Adderall preparation. Additionally, the frequency with which most stimulant-related side effects were experienced did not demonstrate a consistent dose-related incidence, with the exception of anorexia. SLI381 received a letter of approvability in August 2001 and will probably be approved in the immediate future by the US FDA. This formulation represents a valuable addition to the available pharmacotherapeutic options for ADHD by providing an amphetamine-based stimulant offering the advantages of once-daily dosing accompanied by the clinical benefits of ADHD symptom control associated with the now widely used Adderall preparation.

PMID: 11772303

[Wilber_Stool]

3. Maybe they could file a

class action suite. Oh, too bad. Too late.

[wildflower]

6. (Related): Suspension of Adderall XR Sales Not Likely In U.S.

Suspension of Adderall XR Sales Not Likely In U.S.

THURSDAY, Feb. 10 (HealthDay News) -- The Canadian pullback of the drug Adderall XR will not prompt similar measures south of the border.

The U.S. Food and Drug Administration (FDA) said Thursday it was satisfied with the safety profile of the medication, which is used to treat attention-deficit hyperactivity disorder (ADHD).

"Given the data we have in front of us now, we're fairly confident with the decision we've made," said Dr. Russell Katz, director of the division of neuropharmacological drug products at the FDA. "As far as we can tell, the evidence does not indict the drug."

There are 2 million children in the United States who have been diagnosed with ADHD, according to the National Institute of Mental Health. Adderall XR is taken by about 700,000 people in this country, according to the Associated Press, while another 300,000 take the immediate-release form of the medication called Adderall.

much more at

http://www.forbes.com/lifestyle/health/feeds/hscout/2005/02/10/hscout523942.html

[Kagemusha]

7. The FDA won't ban it when even Canada does. (Even Canada!)

Ok, so I'm making a broader point...

[whistle]

8. And so the drug company is promoting adult ADHD....

...and the drugs to treat it.

[Schema Thing]

9. Adderall is wonderful stuff

I can't help it if I need speed to feel human.

Hmmmm, don't give speed to kids with heart defects? Yeah, makes sense to me.

[Jackpine Radical]

10. What the drug companies don't want you to know...

“Among the newer approaches to managing ADD, the most exciting is a learning process called neurofeedback. It empowers a person to shift the way he pays attention. After more than 25 years of research in university labs, neurofeedback has become more widely available. This is a pleasing development, because neurofeedback has no negative side effects.”

- William Sears, MD, The ADD Book

Frank H. Duffy, MD, a professor and pediatric neurologist at Harvard Medical School, authored a January 2002 editorial in the Journal of Clinical Electroencephalography stating that research suggests that neurofeedback, or EEG biofeedback, “should play a major therapeutic role in many difficult areas. In my opinion, if any medication had demonstrated such a wide spectrum of efficacy it would be universally accepted and widely used.”

Check out www.bcia.org for a list of certified providers.

[Psephos]

13. Do you have ADD? n/t

[Jackpine Radical]

15. That queston is more complicated than it sounds on the surface.

First you would have to define ADD. Do you buy into the Amen typology? Do you classify any "attention problem" as ADD?

I've always had some problems with organization & focus & typically have a lot of projects going on at once, but I function moderately well overall, if supervising a couple of outpatient mental health clinics, managing to do a little research, & maintaining a private practice in addition to a full-time job as a chief psychologist in a state agency count as functioning moderately well.

[Psephos]

16. I place less emphasis on classification and more on functional description

I asked because there's often a divide between the opinions of those with ADD and those without.

To answer your question, I don't buy into the Amen typology. Instead, I look for differences in the way I focus and concentrate compared to general population norms. As I see it, ADD isn't a binary proposition, but rather, a position along a gradient. We are all either more or less focused, in the same way we are all either more or less mathematical. Most people can add a couple of two-digit numbers in their head, but only a few can picture the second derivative of the acceleration of a moving body. Same with ADD. Most people can focus easily on what's interesting them at the moment, but considerably fewer can hold focus for a long time on something that is boring or uninteresting.

Due to the way medical and scientific issues are handled by the media, we often end up with caricatures and oversimplifications replacing real understanding. AIDS, fibromyalgia, and depression are handy examples. Or look at how nutritional information is handled. Last year: eat no nuts. This year: eat plenty of nuts. Last year: alcohol is bad. This year: alcohol is good. Last year: low fat. This year: low carbs. Next year: take whatever is "in" this year and flip it around.

You get my point.

From your description of your responsibilities, you don't sound particularly hampered by ADD, else I would expect you wouldn't have lasted in your jobs this far. So on the continuum between hyperfocus and dreamland, you probably fall somewhere in the middle.

I tend to be over more to the dreamland end, and my work and life experience reflect it. ADD is extraordinarily beneficial if one chooses a career in a creative field. My belief is that genes for ADD have become embedded in the genome because all societies need innovators and people who think about "what if?" instead of "right now." Leonardo and Einstein were both classic ADD types. We remember them for their extraordinary creative insights, and overlook the serious problems they caused themselves and others by not taking care of day-to-day mundane tasks.

Not all of us are as fortunate as Einstein and Leonardo in being able to sidestep things like tax forms, parking tickets, and sitting still in a chair at a meeting. I like the sound of the biofeedback approach, but it sounds like it requires a lot more sustained effort in locating a doctor familiar with the technique, attending a clinic with the right equipment, and learning how to apply the conditioning in daily life. In short, due to logistics and practical issues, it probably won't be an answer for a lot of people who might benefit from it.

Adderal works pretty well for me. I use a low dose (three or four milligrams) on days when I need it because of my responsibilities or schedule, and revel in not having to use it on days when I don't. As with almost all medical and pharmaceutical therapies, there are benefits and disadvantages. I take issue with those who are politicizing the use of drugs as an ADD therapy. Some of the shrillest voices talk about poisoned brains, and legions of children turned into drugged zombies. Please. Maybe the drugs aren't for everyone, maybe they're overprescribed, maybe this, maybe that. Each person needs to take responsibility for assessing the benefits versus drawbacks equation for themselves. I am glad to have the choice, and object to anyone who would try to take the choice away from me. Almost always, these people are self-appointed drug police who do not have a direct experience of ADD.

Peace.

[Jackpine Radical]

17. I certainly agree with you about the labelling thing.

Your attentional attributes are only a "disorder" if they cause problems for you (or, in the case of the schools, for other people such as teachers).

I suspect that there are at least two dimensions underlying the general areas of "attention problems." One of them is arousal, with both over- and under-arousal playing roles. I'm not completely sure what the other dimension is, or whether there may be more dimensions yet in "ADDer space." I think in some cases "ADD" is a learned, adaptive response to chaotic and dysfunctional environments. It's better just not to "be there" when craziness is raging.

I personally like Thom Hartmann's conceptualization of ADD/ADHD (hunters v. farmers). I also believe strongly, on the basis of my own clinical experience, that neurotherapy is very useful for helping people to overcome their attention problems, and often in eliminating the need for continuing medication.

[jdj]

11. But all that animal testing was supposed to make it safe for humans right?

dunt dunt dunt, another one bites the dust.

Another FDA million (or billion) dollar drug gone up in smoke.

[Psephos]

12. Keep your self-righteous mitts off my Adderal (please)

I need it.

If you don't need it, good on ya, but for those of us who do, we'd prefer to be our own arbiters of acceptable risk. I know I risk NOT HAVING AN INCOME if ignorant people pressure the FDA to ban it. Do any of the self-appointed pharmacy police consider what effect that might have on health?

Adderal is a combinatin of amphetamine enantiomers. Like all amphetamine-class drugs, it's a stimulant to the autonomic nervous system, and it makes the heart electrically more sensitive. In the vast majority of people taking moderate doses, this causes no problems whatsoever. However, just like caffeine, it can cause problems in people who have a history of irregular heartbeats. That's one reason why it's a prescription medication.

You can die by drinking 30 glasses of water. Should we ban water? You can die by choking on a piece of hot dog. Ban them? You can die driving over to the pharmacy to pick up your Adderal. Ban driving? (In fact, your chances of being in a life-threatening or life-ending car accident in your lifetime are about one in two.)

I've got a better idea. Let's accept that every moment of every day, there are risks. Understanding what constitutes acceptable risk involves weighing the benefits against the probability of trouble. Unfortunately, if you only weigh this based upon emotions stirred by news articles, you will make some very poor decisions.

[OR Ruminator]

24. Well put!

[proudbluestater]

14. Sad to break this to you all, but the drug companies now PAY the FDA

to get their drugs approved. Can you say conflict of interest? That would certainly explain the recent uptick in the number of drugs that are known to cause deaths, that the FDA refuses to ban.


Heard it on Democracy Now!

[Skittles]

20. even sadder is the pharmo industry has convinced so many people

they need drugs EVERY DAY to "feel right"

and DON'T get on my case - I have SEVERE ADD but do not like the idea of being dependent on a drug for the rest of my life. I have found better solutions - one being lots of exercise and not trying to hold myself to a regular sleep schedule

[depakid]

18. Is the company disclosing all the data? What about relative risk?

From the NY Times article on Thursday;

Senator Says F.D.A. Asked Canada Not to Suspend Drug

...Some of the deaths, which had not been previously reported to Canadian authorities, occurred well before Health Canada approved Adderall XR for sale, Dr. Peterson (of Health Canada) said. Canada and the United States both require pharmaceutical companies to report all adverse outcomes from drugs promptly.

"We were surprised to find these cases," Dr. Peterson said in an interview on Thursday. Dr. Peterson said that an early analysis of the data suggested that Adderall XR might be linked to two to three times as many sudden deaths as Ritalin and its cousin, Concerta, which are prescribed for similar disorders.

Further, Dr. Peterson said that Canadian authorities were uncertain about how to warn patients about the risks of sudden death. It's very difficult to generate a benefit-to-risk balance when the risk is sudden and unexpected death," Dr. Peterson said.

So, researchers don't know whether there's a risk of excess deaths directly attritable to adderall or not- but the preliminary data indicate THAT THERE IS A 2-3 TIMES GREATER RELATIVE RISK OF SUDDEN DEATH compared with Ritalin and its cousin, Concerta, which are prescribed for similar disorders.

Moreover, the chances are very good that if this data wasn't provided (as reqired) to Canadian regulators)- then there's more out there.

Given the pattern of corruption and cover-up at the FDA regarding VIOX, Celexa, Paxil, and Phen-Fen- just to name a few, it's clear that the FDA can no longer be trusted to protect the public health.

Canada is being smart by erring (if they are erring at all) on the side of caution- protecting our kids as opposed to pharmaceutical profits.

If it were me or my child, I would too....

[lazarus]

19. READ THE ARTICLE

Please, people, read the article.

First, there were 12 deaths out of 1 million people taking the drug, over 4 years.

The 12 deaths were in 7- to 16-year-old U.S. boys. They'd been taking Adderall products for as little as one day or as long as eight years. Five of the deaths were in kids with known heart defects. Many of the other seven children had unusual circumstances that make the link to Adderall hard to interpret, says Russell Katz, MD, director of the FDA's neurological drugs office.

"One child was in a boot camp and exercising in 110 degrees," Katz says. "Two others had high blood levels of the drug, possibly reflecting an overdose. They way we try to assess causality -- to ask, 'Did the drug do this?' -- it is hard to answer that by looking at an individual case. Just because a child died while on Adderall doesn't mean the drug was the cause. It could have been 50 different causes. So we look at how many deaths there were in kids exposed to Adderall, and compare that to the background rate in the population. We don't really believe this is different than background rate, although we have no good data on the actual background rate of sudden death in all kids -- or in kids with ADHD, who may have a higher background rate."

[depakid]

22. Read between the lines- and read Heath Canada's Advisory

Trusting the current FDA or the information in this "Web Md" article in isolation is a fool's errand.

Here's the official

Health Canada Advisory

Health Canada suspends the market authorization of ADDERALL XR® , a drug prescribed for Attention Deficit Hyperactivity Disorder (ADHD) in children

Health Canada is informing Canadians that it has instructed Shire BioChem Inc., the manufacturer of ADDERALL XR® to withdraw the drug from the Canadian market. Health Canada has suspended the market authorization of the product due to safety information concerning the association of sudden deaths, heart-related deaths, and strokes in children and adults taking usual recommended doses of ADDERALL® and ADDERALL XR®. The immediate release form of ADDERALL® has never been marketed in Canada.

Health Canada is advising patients who are currently being treated with ADDERALL XR® to consult their physician immediately about use of the drug and selecting treatment alternatives.

Health Canada's decision comes as a result of a thorough review of safety information provided by the manufacturer, which indicated there were 20 international reports of sudden death in patients taking either ADDERALL® (sold in the United States, not in Canada) or ADDERALL XR® (sold in Canada). These deaths were not associated with overdose, misuse or abuse. Fourteen deaths occurred in children, and six deaths in adults. There were 12 reports of stroke, two of which occurred in children. None of the reported deaths or strokes occurred in Canada.

A preliminary review of safety data for the other related stimulants authorized for use in the treatment of ADHD in Canada has been conducted. In that review, the incidence of serious adverse reactions leading to death was higher in ADDERALL® and ADDERALL RX combined than in the other drugs of this class.

Health Canada has asked manufacturers of other related stimulants approved for the treatment of ADHD to provide a thorough review of their worldwide safety data. Information updates will be provided by Health Canada as they become available.

Patients taking drugs of the same class for the management of ADHD should NOT discontinue their medication, and should consult with their physician if they have any concerns or questions.

ADDERALL XR®, a Central Nervous System (CNS) stimulant, was approved in Canada on January 23, 2004 for the management of Attention Deficit Hyperactivity Disorder (ADHD) in children.

After having consulted with their physician, consumers should not flush unused drugs down the toilet or sink to avoid contaminating ground or municipal water systems but return any unused product to their pharmacy.

Health Canada has been in contact with Shire BioChem Inc., and will be monitoring the removal of this product from the Canadian market.

Health Canada relies on the active participation of health care professionals in adverse reaction reporting programs. Occurances of cardiac or other serious and/or unexpected adverse reactions in patients taking drugs of the same class should be reported to Health Canada at the following address:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9

Tel: [phone] or
Fax: [phone]

To report an Adverse Reaction, consumers and health professionals may call toll-free:
Tel: [phone]
Fax: [phone]
[e-mail]

For other inquiries: please refer to contact information.

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adverse_e.html
www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.html

[lazarus]

23. And in that same time period

over a million people were taking it.

Aspirin likely has a higher mortality rate.

[Dark]

21. Never mind the millions who take Adderall and go about their lives just

fine, or that some of the kids probably took way more than the recomended dose so they could get high.

This is bullshit. If the kids had a medical condition, then their doctor should not have prescribed adderal.

Don't blame the pharmaceutical companies every time. Blame the doctors who over-prescibe Adderall and ignore the side effects, or the parents who rely on it to 'perfect' their children. . .