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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 20 of 20. This is the beginning of the thread.
Posted by Jen2 on February 10, 2005, at 20:29:41
I'm just watching the nighttime national news here in Canada. They've just announced that Health Canada (it's like the FDA in the States) is pulling Adderall XR off the market because it has been linked to 20 deaths and 12 strokes, most of which happened in the US.
For more info, check:
www.cbc.ca/story/science/national/2005/02/10/ADHD-Adderall050210.html
They're also now reviewing Ritalin, Concerta, Dexadrine and Attenade to determine safety.
I thought everyone would want to know.
Jen
Posted by banga on February 10, 2005, at 21:33:14
In reply to Adderall XR pulled in Canada, posted by Jen2 on February 10, 2005, at 20:29:41
Did they say permanently, or temporarily?
Posted by Jen2 on February 10, 2005, at 21:40:07
In reply to Re: Adderall XR pulled in Canada, posted by banga on February 10, 2005, at 21:33:14
> Did they say permanently, or temporarily?
It doesn't say specifically, but I assume they meant permanently.
Posted by Optimist on February 11, 2005, at 9:31:53
In reply to Adderall XR pulled in Canada, posted by Jen2 on February 10, 2005, at 20:29:41
> I'm just watching the nighttime national news here in Canada. They've just announced that Health Canada (it's like the FDA in the States) is pulling Adderall XR off the market because it has been linked to 20 deaths and 12 strokes, most of which happened in the US.
>
> For more info, check:
>
> www.cbc.ca/story/science/national/2005/02/10/ADHD-Adderall050210.html
>
> They're also now reviewing Ritalin, Concerta, Dexadrine and Attenade to determine safety.
>
> I thought everyone would want to know.
>
> JenI live in Canada. Good thing I finished my Adderall XR trial last week. No sudden deaths or strokes either. Few... :)
Brian
Posted by linkadge on February 11, 2005, at 14:57:58
In reply to Re: Adderall XR pulled in Canada » Jen2, posted by Optimist on February 11, 2005, at 9:31:53
Wow, if they pulled ritalin, their would be big problems.
Linkadge
Posted by med_empowered on February 11, 2005, at 16:05:00
In reply to Re: Adderall XR pulled in Canada, posted by linkadge on February 11, 2005, at 14:57:58
What do you guys think of this? Granted, they may be operating on data that has yet to be made public, but still...what are everyone's thoughts? I'm torn. On the one hand, I take adderall, and I know amphetamines have a 60+ year history of pharmaceutical use with both ups and downs, so I'm kind of leaning towards the FDA's approach: schedule II, warning labels, expect doctors to be cautious, but don't ban the chemical. But...the FDA is a little too cozy with the pharmaceutical industry, especially these days it seems (the FDA head is a former lawyer for the drug companies). So, I'm torn...and it sucks to the Nth degree for me, since I take 60mgs of this stuff daily. Thoughts? Comments?
Posted by Phillipa on February 11, 2005, at 17:34:42
In reply to Re: Adderall XR pulled in Canada, posted by med_empowered on February 11, 2005, at 16:05:00
What about the USA? I know a lot of people who use this drug. Fondly, Phillipa
Posted by med_empowered on February 11, 2005, at 18:01:51
In reply to Re: Adderall XR pulled in Canada, posted by Phillipa on February 11, 2005, at 17:34:42
Apparently, the FDA is just fine with the way its handling Adderall right now...the article I read indicated that they're not planning any further regulatory action, at least not for now. Also, some senator from Iowa, I think, is accusing the FDA of trying to stop the Canadians from pulling Adderall. Scary.
Posted by Phillipa on February 11, 2005, at 18:09:44
In reply to Re: Adderall XR pulled in Canadaphillipa, posted by med_empowered on February 11, 2005, at 18:01:51
I've been following you along all day it seems in Posts. You seem to have a lot of knowledge. Maybe I've already said this to you, but what do you as far as career is concerned? You said you are only 20, are you in school now? Fondly, Phillipa
Posted by med_empowered on February 11, 2005, at 20:30:19
In reply to Re: Adderall XR pulled in Canadaphillipa » med_empowered, posted by Phillipa on February 11, 2005, at 18:09:44
hey! I'm in school now getting my degree in sociology/english. In sociology, I had a freshman level course that included some mental health stuff like the mother's little helpers era and that kind of thing, and my interest in meds kind of took off from there. In addition, I'm (according to one shrink) bipolar of some sort, so I've been on a number of meds lately. Thanks for your compliment!
Posted by Phillipa on February 11, 2005, at 20:58:25
In reply to Re: Adderall XR pulled in Canadaphillipa, posted by med_empowered on February 11, 2005, at 20:30:19
Compliment? With your knowledge maybe you need to switch to psychiatry. What a joy it would be to pts to have a pdoc who REALLY understood them! Fondly, Phillipa
Posted by Maxime on February 11, 2005, at 22:57:34
In reply to Re: Adderall XR pulled in Canadaphillipa, posted by med_empowered on February 11, 2005, at 18:01:51
I love being Canadian and proud of my country, but why is it so strict with meds? We don't have lexapro, abilify and other meds.
Great. I get to go through withdrawal.
Maxime
Posted by Maxime on February 11, 2005, at 22:59:56
In reply to Re: Adderall XR pulled in Canada, posted by Maxime on February 11, 2005, at 22:57:34
Also, would have been nice to drop dead from the med. Would want to live with effects of a stroke. How am I going to do this ...
Max
Posted by Ron Hill on February 11, 2005, at 23:41:18
In reply to Adderall XR pulled in Canada, posted by Jen2 on February 10, 2005, at 20:29:41
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.
Shire Pharmaceuticals - the manufacturer of Adderall -- reported the 12 child deaths to U.S. and Canadian regulatory agencies. They occurred in the U.S. between 1999 and 2003 - a time when doctors wrote more than 37 million Adderall prescriptions for about 1 million patients worldwide. The reports of sudden death occurred in children taking Adderall or Adderall XR.
Shire strongly disagrees with Health Canada's interpretation of the deaths, says company spokesman Matthew Cabrey."Adderall and Adderall XR are safe, effective treatments for people diagnosed with ADHD," Cabrey tells WebMD. "There is no difference in the risk of sudden death in the population of people taking this drug compared to the population of people not taking this drug."
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."
What Parents Should Know
If your child is taking Adderall or Adderall XR, what should you do?
WebMD asked Leslie Rubin, MD, director of developmental pediatrics at Emory University School of Medicine.
"Everything we take has the potential for causing us grievous bodily harm, as innocuous as it may appear," Rubin tells WebMD. "We should really, whenever we take a medicine, be quite cognizant of its potential for causing harm."
But, Rubin says, there are excellent reasons to take these risks.
"When a medicine has been used widely and effectively and routinely, we should always be very cautious interpreting things like these Adderall reports," he says. "Taking a drug off the market for something like this is a mistake. Because a lot of people benefit from this drug. They depend on it for their day-to-day function."
If parents whose children are taking Adderall are worried, Rubin says, they have two basic options.
The first is to call their child's doctor and, with his or her approval, to stop giving them the drug until the doctor can give the child's heart a clean bill of health.
The other option is to continue giving the child Adderall, but to schedule an appointment with the child's doctor in order to discuss alternatives to Adderall treatment.
--------------------------------------------------------------------------------SOURCES: FDA, Statement on Adderall and Public Health Advisory for Adderall and Adderall XR, Feb. 9, 2005. Advisory, Health Canada, Feb. 9, 2005. News release, Shire Pharmaceuticals, Feb. 10, 2005. Russell Katz, MD, director, division of neuropharmacological drug products, office of drug evaluation, CDER, FDA. Matthew Cabrey, spokesman, Shire Pharmaceuticals. Leslie Rubin, MD, director of developmental pediatrics, Emory University School of Medicine; director, Marcus Center for Developmental Medicine, Marcus Institute, Atlanta; and co-director, southeast pediatric environmental health unit at the Rollins School of Public Health, Emory University, Atlanta.
Next Article: Sudden Death in 12 Kids on
Posted by theo on February 12, 2005, at 19:46:59
In reply to Re: Adderall XR pulled in Canada » Jen2, posted by Optimist on February 11, 2005, at 9:31:53
What was your trial experience like with Adderall XR? Was it positive or negative?
Posted by Optimist on February 12, 2005, at 23:14:39
In reply to Re: Adderall XR pulled in Canada » Optimist, posted by theo on February 12, 2005, at 19:46:59
> What was your trial experience like with Adderall XR? Was it positive or negative?
I would say it was pretty positive overall. I found it a little too agitating/anxiety provoking than I'd have liked, especially in social situations. Prehaps dextroamphetamine would have been a better choice. Caffeine is much better with anxiety in that regard. I find caffeine very prosocial for me. I found the energy and motivation Adderall gave me was quite effective as well, perhaps superior to caffeine.
Since I don't have ADD or ADHD I didn't find it effected my concentration anything amazing although I did find it helped some.
For me I wouldn't have said it's a wonderdrug or anything. I was wondering towards the end if it was losing some of it's effectiveness. More breaks probably would have been appropriate, but I found the days I didn't take anything I felt like a slug and couldn't feel like I could do much of anything.
Hope that's what you were looking for.
Brian
Posted by theo on February 13, 2005, at 12:45:42
In reply to Re: Adderall XR pulled in Canada » theo, posted by Optimist on February 12, 2005, at 23:14:39
I've never tried a stimulant and was thinking about trying Adderall XR just to see how it effects me. I've tried numerous SSRI's and they just make me not care and my work ethic goes down the tubes. Mood stabilzers make my forgetfull and depressed.
My main concern is anxiety. Were you on a pretty low dose? Did you ever try Concerta?
Posted by Optimist on February 13, 2005, at 23:37:57
In reply to Re: Adderall XR pulled in Canada » Optimist, posted by theo on February 13, 2005, at 12:45:42
> I've never tried a stimulant and was thinking about trying Adderall XR just to see how it effects me. I've tried numerous SSRI's and they just make me not care and my work ethic goes down the tubes. Mood stabilzers make my forgetfull and depressed.
>
> My main concern is anxiety. Were you on a pretty low dose? Did you ever try Concerta?I started at 5mg, then gradually tapered up to 30mg. I haven't tried any other stimulants other than caffeine, and ephedrine. Ephedrine causes a lot of peripheral stimulation and anxiety, lots of energy. I wouldn't recommend it though.
If you're worrying about anxiety your best choice would be dextroamphetamine, then Adderall, followed by Ritalin, in that order. You can only tell by trying. Your work ethic will go up most likely if anything. If felt a lot more motivated when I was on it.
Brian
Posted by catachrest on February 15, 2005, at 8:19:54
In reply to Re: Adderall XR pulled in Canada » theo, posted by Optimist on February 13, 2005, at 23:37:57
Hi there,
This is the advisory posted on Health Canada's website (http://www.hc-sc.gc.ca) in the form of a health professionals letter.
February 9, 2005
Subject: Health Canada has suspended market authorization of ADDERALL XRTM (amphetamine salts), a drug approved for Attention Deficit Hyperactivity Disorder (ADHD) in children.
Dear Health Care Professional,
Health Canada advises you that marketing of the Attention Deficit Hyperactivity Disorder (ADHD) drug, ADDERALL XRTM (amphetamine salts) has been suspended effective February 9, 2005. ADDERALL XRTM, marketed by Shire BioChem Inc., is a prescription drug that was authorized in Canada for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children.
Health Canada's decision to withdraw ADDERALL XRTM is founded on very rare, international, spontaneous reports of sudden deaths, in paediatric and adult patients in association with ADDERALL® (immediate release) and ADDERALL XRTM (extended release). Reports for death include those for patients taking usual recommended doses, including recommended starting doses, of ADDERALL® and ADDERALL XRTM. In a minority of cases, the events occurred on the first day of dosing or shortly after an increase in dose or a switch from another drug in the structural class. Deaths were reported for patients both naïve or chronically exposed to amphetamine-related Central Nervous System stimulants. This decision was not based on reported deaths that were associated with overdose, misuse or abuse. Of the 20 reported deaths, there were cases that occurred in patients without a documented history of structural or other cardiac abnormalities/disease. In a few cases, other drugs, including anti-depressants, clonidine and/or anti-psychotics, were concomitant medications. Exercise was an associated event in some of the reports of death. None of the reported deaths occurred in Canada.
Health Canada is aware of 20 international reports of sudden death in patients taking either ADDERALL® (immediate release) or ADDERALL XRTM (extended release) with 3.45 million patient-years of exposure. 14 deaths occurred in children, and 6 deaths in adults. ADDERALL XRTM has been marketed in Canada since January 23, 2004, while the immediate release form of ADDERALL® has never been marketed in Canada.
A preliminary review of safety data for the other stimulants authorized for use in the treatment of ADHD in Canada has been conducted. The incidence of serious adverse reactions leading to death was higher in ADDERALL®/ADDERALL XRTM than in the other stimulants, based upon these reviews. In addition, the safety information submitted to Health Canada also included 12 reported cases of stroke, with 2 occurring in children.
Health Canada has requested manufacturers of other stimulants approved for the treatment of ADHD provide a thorough review of their worldwide safety data. Information updates will be provided as they become available.
Health Canada reminds physicians of the following wording currently contained in Product Monographs of all drugs indicated for the management of ADHD: "[X] is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms."
The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse reaction reporting programmes. Any occurrences of cardiac or other serious and/or unexpected adverse reactions in patients receiving ADHD treatments 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: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.caFor other inquiries: please refer to contact information:
Bureau of Cardiology, Allergy and Neurological Sciences
E-mail: bcans_enquiries@hc-sc.gc.ca
Tel: (613) 941-1499
Fax.: (613) 941-1668The 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.
Posted by Maxime on February 15, 2005, at 20:06:18
In reply to Re: Adderall XR pulled in Canada - HC statement, posted by catachrest on February 15, 2005, at 8:19:54
So that means I can still get it if my doctor says it is okay? I am confused ....
Maxime
> Hi there,
>
> This is the advisory posted on Health Canada's website (http://www.hc-sc.gc.ca) in the form of a health professionals letter.
>
> February 9, 2005
>
> Subject: Health Canada has suspended market authorization of ADDERALL XRTM (amphetamine salts), a drug approved for Attention Deficit Hyperactivity Disorder (ADHD) in children.
>
> Dear Health Care Professional,
>
> Health Canada advises you that marketing of the Attention Deficit Hyperactivity Disorder (ADHD) drug, ADDERALL XRTM (amphetamine salts) has been suspended effective February 9, 2005. ADDERALL XRTM, marketed by Shire BioChem Inc., is a prescription drug that was authorized in Canada for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children.
>
> Health Canada's decision to withdraw ADDERALL XRTM is founded on very rare, international, spontaneous reports of sudden deaths, in paediatric and adult patients in association with ADDERALL® (immediate release) and ADDERALL XRTM (extended release). Reports for death include those for patients taking usual recommended doses, including recommended starting doses, of ADDERALL® and ADDERALL XRTM. In a minority of cases, the events occurred on the first day of dosing or shortly after an increase in dose or a switch from another drug in the structural class. Deaths were reported for patients both naïve or chronically exposed to amphetamine-related Central Nervous System stimulants. This decision was not based on reported deaths that were associated with overdose, misuse or abuse. Of the 20 reported deaths, there were cases that occurred in patients without a documented history of structural or other cardiac abnormalities/disease. In a few cases, other drugs, including anti-depressants, clonidine and/or anti-psychotics, were concomitant medications. Exercise was an associated event in some of the reports of death. None of the reported deaths occurred in Canada.
>
> Health Canada is aware of 20 international reports of sudden death in patients taking either ADDERALL® (immediate release) or ADDERALL XRTM (extended release) with 3.45 million patient-years of exposure. 14 deaths occurred in children, and 6 deaths in adults. ADDERALL XRTM has been marketed in Canada since January 23, 2004, while the immediate release form of ADDERALL® has never been marketed in Canada.
>
> A preliminary review of safety data for the other stimulants authorized for use in the treatment of ADHD in Canada has been conducted. The incidence of serious adverse reactions leading to death was higher in ADDERALL®/ADDERALL XRTM than in the other stimulants, based upon these reviews. In addition, the safety information submitted to Health Canada also included 12 reported cases of stroke, with 2 occurring in children.
>
> Health Canada has requested manufacturers of other stimulants approved for the treatment of ADHD provide a thorough review of their worldwide safety data. Information updates will be provided as they become available.
>
> Health Canada reminds physicians of the following wording currently contained in Product Monographs of all drugs indicated for the management of ADHD: "[X] is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms."
>
> The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse reaction reporting programmes. Any occurrences of cardiac or other serious and/or unexpected adverse reactions in patients receiving ADHD treatments 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: (613) 957-0337 or Fax: (613) 957-0335
> To report an Adverse Reaction, consumers and health professionals may call toll free:
> Tel: 866 234-2345
> Fax: 866 678-6789
> cadrmp@hc-sc.gc.ca
>
> For other inquiries: please refer to contact information:
>
> Bureau of Cardiology, Allergy and Neurological Sciences
> E-mail: bcans_enquiries@hc-sc.gc.ca
> Tel: (613) 941-1499
> Fax.: (613) 941-1668
>
> 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.
>
>
This is the end of the thread.
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