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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 14 of 14. This is the beginning of the thread.
Posted by catachrest on August 30, 2005, at 9:18:32
From the Health Canada web site:
2005-92
August 24, 2005
For immediate releaseHealth Canada allows Adderall XR® back on the Canadian market
OTTAWA - Health Canada will allow Shire BioChem Inc., the manufacturer of Adderall XR®, to resume sales of the drug on the Canadian market following the recommendation of an independent and external committee appointed under the Food and Drugs Act.The committee, known as a New Drug Committee (NDC), reviewed the suspension of the sale of Adderall XR® , a drug used for the management of Attention Deficit Hyperactivity Disorder (ADHD). The suspension took place on February 9, 2005 due to safety information concerning possible sudden deaths, heart-related deaths, and strokes in children and adults taking regular recommended doses of Adderall® and Adderall XR®.
The NDC reviewed the information on which Health Canada based its decision earlier this year and concluded that the Department's actions were appropriate. The NDC made a number of recommendations in its review and Health Canada has accepted them all. The NDC's recommendations will be available on the Health Canada website in the coming days.
In line with the committee's recommendation, Health Canada has agreed to reinstate the marketing authorisation for Adderall XR® with a number of revisions to the Adderall XR labelling. In particular, labelling will be revised to include warnings against the use of Adderall XR in patients with structural heart abnormalities. Another warning will advise about the dangers of misusing amphetamines.
The committee also recommended that Shire BioChem Inc. distribute a letter to healthcare professionals to inform them about risks associated with use of the product. In addition, the committee recommended that the manufacturer support independent continuing medical education for Canadian physicians to reinforce their understanding of the issues around sudden/cardiac death in the pediatric population.
Also, in line with the committee's recommendations, Health Canada is committed to enhancing post-market surveillance of all stimulant drugs used in the management of Attention Deficit Hyperactivity Disorder. Specifically, Health Canada will request that Shire BioChem Inc. provide safety information to Health Canada on a regular basis.
Under Food and Drug Regulations, when a drug is withdrawn from the market under article C.08006 of the Food and Drug Act, as was the case with Adderall XR®, drug manufacturers have the option of requesting the appointment of a New Drug Committee to review Health Canada's decision. The committee was comprised of three independent experts in the areas of pediatric cardiology, pediatric development and behavioural problems, and pharmacoepidemiology.
Health Canada is advising patients to consult their physicians, who will be receiving additional information from Shire BioChem Inc., about use of the drug.
Adderall XR®, a central nervous system stimulant, was approved in Canada on January 23, 2004. Adderall®, the immediate-release form of the drug, has never been marketed in Canada.
Health Canada relies on the active participation of health care professionals in adverse reaction reporting programs. Cases 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: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 1 866 234-2345
Fax: 1 866 678-6789
cadrmp@hc-sc.gc.caFor 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.
Note: Health Canada issued another advisory on this topic on February 9, 2005. To access this advisory, visit:
www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/2005_01_e.html
Posted by Phillipa on August 30, 2005, at 17:51:27
In reply to Adderall re-allowed in Canada, posted by catachrest on August 30, 2005, at 9:18:32
Wow Maxime will be thrilled! I'll have to E-mail this to her. Fondly, Phillipa
Posted by Paulbwell on August 31, 2005, at 22:14:47
In reply to Re: Adderall re-allowed in Canada » catachrest, posted by Phillipa on August 30, 2005, at 17:51:27
> Wow Maxime will be thrilled! I'll have to E-mail this to her. Fondly, Phillipa
I wonder how many more kids will die this time around? before a second redrawall??
Gotta keep thoes $$ coming in Shire pharmaceuticals?
Cheers
Cheers
Posted by Phillipa on September 1, 2005, at 17:08:27
In reply to Dead Kids??, posted by Paulbwell on August 31, 2005, at 22:14:47
I must be missing something but it killed kids? How is it different from ritalin? Fondly, Phillipa
Posted by Paulbwell on September 1, 2005, at 17:55:23
In reply to Re: Dead Kids?? » Paulbwell, posted by Phillipa on September 1, 2005, at 17:08:27
> I must be missing something but it killed kids? How is it different from ritalin? Fondly, Phillipa
There were many deaths (Heart abnormalities) due to Adderall XR in Canada-hence it's withdrawall
Cheers
Posted by alohashirt on September 1, 2005, at 22:56:14
In reply to Re: Dead Kids??, posted by Paulbwell on September 1, 2005, at 17:55:23
> > I must be missing something but it killed kids? How is it different from ritalin? Fondly, Phillipa
>
> There were many deaths (Heart abnormalities) due to Adderall XR in Canada-hence it's withdrawall
>It wasn't clear to me that there was a definitive conclusion that the deaths in question would not have occured if the children were not taking medication. I'm not saying Adderall does or doesn't kill - but that it wasn't clear that the data was conclusive.
Posted by Bowtie Bob on September 2, 2005, at 7:26:32
In reply to Re: Dead Kids??, posted by alohashirt on September 1, 2005, at 22:56:14
> > > I must be missing something but it killed kids? How is it different from ritalin? Fondly, Phillipa
> >
> > There were many deaths (Heart abnormalities) due to Adderall XR in Canada-hence it's withdrawall
> >
>
> It wasn't clear to me that there was a definitive conclusion that the deaths in question would not have occured if the children were not taking medication. I'm not saying Adderall does or doesn't kill - but that it wasn't clear that the data was conclusive.
>
I think the conclusion was that anyone who is pre-disposed to cardiac problems, or has a pre-existing one, is at much higher risk.
Posted by Paulbwell on September 4, 2005, at 23:21:22
In reply to Re: Dead Kids??, posted by Bowtie Bob on September 2, 2005, at 7:26:32
> > > > I must be missing something but it killed kids? How is it different from ritalin? Fondly, Phillipa
> > >
> > > There were many deaths (Heart abnormalities) due to Adderall XR in Canada-hence it's withdrawall
> > >
> >
> > It wasn't clear to me that there was a definitive conclusion that the deaths in question would not have occured if the children were not taking medication. I'm not saying Adderall does or doesn't kill - but that it wasn't clear that the data was conclusive.
> >
>
>
> I think the conclusion was that anyone who is pre-disposed to cardiac problems, or has a pre-existing one, is at much higher risk.
>^Agreed as with Desipramine (in childhood bedweeting)Stimulants ESPECIALLY Adderall with it's Cardio l-Amphetamine component can precipate Heart problems.
Cheers
Posted by alohashirt on September 5, 2005, at 22:29:08
In reply to Re: Dead Kids??, posted by Bowtie Bob on September 2, 2005, at 7:26:32
> > > > I must be missing something but it killed kids? How is it different from ritalin? Fondly, Phillipa
> > >
> > > There were many deaths (Heart abnormalities) due to Adderall XR in Canada-hence it's withdrawall
> > >
> >
> > It wasn't clear to me that there was a definitive conclusion that the deaths in question would not have occured if the children were not taking medication. I'm not saying Adderall does or doesn't kill - but that it wasn't clear that the data was conclusive.
> >
>
>
> I think the conclusion was that anyone who is pre-disposed to cardiac problems, or has a pre-existing one, is at much higher risk.
>
The data didn't support that conclusion (I'm not saying it isn't true.) There were no such deaths in Canada. There were 12 sudden unexpected deaths worldwide in children who were taking Adderall or Adderall XR. This is out of approx 1 million children taking Adderall. Five of these children had structural heart abnormalities, one had been overexerting, one was believed to have overdosed. There are no statistics about the number of children who don't take Adderall that die similarly. It is known that about 4 or 5 children per million die annually of cardiac problems. These data points really don't point to an incxreased risk through use of Adderall. There is also no data that compares the rate of accidental death in ADHD children who do and don't receive stimulant treatment. There is experimental evidence that children who take Adderall or Ritalin score significantly better in Driver Education simulations.
Posted by catachrest on September 6, 2005, at 9:22:03
In reply to Re: Dead Kids??, posted by alohashirt on September 5, 2005, at 22:29:08
Health Canada has two new documents up on the reintroduction of Adderall XR to Canada. The first is an Advisory (I think to health professionals), the second is the report of the Adderall XR New Drug Committee. You can find them here:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/index_e.html
Posted by gromit on September 6, 2005, at 13:54:34
In reply to Re: Dead Kids??, posted by Paulbwell on September 4, 2005, at 23:21:22
> ^Agreed as with Desipramine (in childhood bedweeting)Stimulants ESPECIALLY Adderall with it's Cardio l-Amphetamine component can precipate Heart problems.
Do you have some links to studies showing l-amphetamine has more cardiac effects than dex? I started adderall xr 20 mg a week ago and had to go back and get 5mg. It was making my heart race and my pressure was way up. Also I don't like the xr, I can definately feel the second dose kick in when I'm just fine and don't want more. Maybe dexedrine spansules would be better for me.
Rick
Posted by Paulbwell on September 6, 2005, at 15:22:02
In reply to Re: Dead Kids??, posted by gromit on September 6, 2005, at 13:54:34
> > ^Agreed as with Desipramine (in childhood bedweeting)Stimulants ESPECIALLY Adderall with it's Cardio l-Amphetamine component can precipate Heart problems.
>
> Do you have some links to studies showing l-amphetamine has more cardiac effects than dex? I started adderall xr 20 mg a week ago and had to go back and get 5mg. It was making my heart race and my pressure was way up. Also I don't like the xr, I can definately feel the second dose kick in when I'm just fine and don't want more. Maybe dexedrine spansules would be better for me.
>
>
> Rick
>Hi,
MANY find Dextroamphetamine only, to be 'smoother' Than Adderall, which containing L-Amphetamine has more somatic activity and was used as a diet pill in the past Called 'Obetrol' Cerebral AND Somatic stimulation, and MANY don't like XR stims, they like the predicatability of IR 2~5 hour actions where they can tailor the use according to their activities.
Cheers
Posted by gromit on September 6, 2005, at 20:16:32
In reply to Re: Dead Kids??, posted by Paulbwell on September 6, 2005, at 15:22:02
> > > ^Agreed as with Desipramine (in childhood bedweeting)Stimulants ESPECIALLY Adderall with it's Cardio l-Amphetamine component can precipate Heart problems.
> >
> > Do you have some links to studies showing l-amphetamine has more cardiac effects than dex? I started adderall xr 20 mg a week ago and had to go back and get 5mg. It was making my heart race and my pressure was way up. Also I don't like the xr, I can definately feel the second dose kick in when I'm just fine and don't want more. Maybe dexedrine spansules would be better for me.
> >
> >
> > Rick
> >
>
> Hi,
>
> MANY find Dextroamphetamine only, to be 'smoother' Than Adderall, which containing L-Amphetamine has more somatic activity and was used as a diet pill in the past Called 'Obetrol' Cerebral AND Somatic stimulation, and MANY don't like XR stims, they like the predicatability of IR 2~5 hour actions where they can tailor the use according to their activities.I've read that dex might be smoother and have less cardio type effects, I'm looking for something a doctor might take seriously. Gave up on my worthless pdoc, got adderall from my GP and I'm not sure how familiar she is with dexedrine in case the adderall doesn't work out.
I've had problems with every extended release drug I've taken, wellbutrin xl had to be the worse of the bunch though.
Thanks,
Rick
Posted by alohashirt on September 6, 2005, at 22:59:13
In reply to Re: Dead Kids??, posted by gromit on September 6, 2005, at 20:16:32
> > > > ^Agreed as with Desipramine (in childhood bedweeting)Stimulants ESPECIALLY Adderall with it's Cardio l-Amphetamine component can precipate Heart problems.
> > >
> > > Do you have some links to studies showing l-amphetamine has more cardiac effects than dex? I started adderall xr 20 mg a week ago and had to go back and get 5mg. It was making my heart race and my pressure was way up. Also I don't like the xr, I can definately feel the second dose kick in when I'm just fine and don't want more. Maybe dexedrine spansules would be better for me.
> > >
> > >
> > > Rick
> > >
> >
> > Hi,
> >
> > MANY find Dextroamphetamine only, to be 'smoother' Than Adderall, which containing L-Amphetamine has more somatic activity and was used as a diet pill in the past Called 'Obetrol' Cerebral AND Somatic stimulation, and MANY don't like XR stims, they like the predicatability of IR 2~5 hour actions where they can tailor the use according to their activities.
>
> I've read that dex might be smoother and have less cardio type effects, I'm looking for something a doctor might take seriously. Gave up on my worthless pdoc, got adderall from my GP and I'm not sure how familiar she is with dexedrine in case the adderall doesn't work out.
>
> I've had problems with every extended release drug I've taken, wellbutrin xl had to be the worse of the bunch though.
>
> Thanks,
> RickJohn Ratey states that dexedrine can be smoother in a paper surveying drug options for ADHD. The paper can be downloaed from his website.
This is the end of the thread.
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