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    Old 02-21-2005, 04:40 AM   #1
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    ADDERAL taken off Canadian market

    Did you all know that Adderal was taken off the Canadian market last Friday for causing at leasr 40 cases of sudden death in children? It's caused strokes and heart attacks too. My son ran out of his Adderal and he's not going back on it.
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    Old 02-21-2005, 07:30 AM   #2
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    Re: ADDERAL taken off Canadian market

    It was 20 deaths, not 40, and "only" 2 out of those were strokes in children - please check your info before posting

    I am not sure from the wording whether it is "just" Adderal XR or all forms of it that were withdrawn?

    I do wonder whether the fact that 4 amphetamine salts are mixed in this (NOT just dex, as the article below states) has something to do with the higher incidence of strokes?

    Quote:
    Britain's Shire Pharmaceuticals said on Thursday that Canada has requested the suspension of sales of its attention deficit hyperactivity disorder treatment, Adderall XR (dextroamphetamine), because of safety concerns.

    In a statement the company said it was complying with the request but "strongly disagreed" with the decision of the Canadian regulator, Health Canada, which was based on its interpretation of adverse event data during a routine label update.

    Health Canada said in a statement it had 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

    "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 or Adderall XR.

    "These deaths were not associated with overdose, misuse or abuse. Fourteen deaths occurred in children, and 6 deaths in adults. There were 12 reports of stroke, 2 of which occurred in children.

    "A preliminary review of safety data for the other related stimulants authorised 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 XR 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."

    A Shire spokeswoman told APM that the 20 deaths were reported over a 10-year period during which time more than one million people had taken 37 million prescriptions of Adderall and Adderall XR.
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    Last edited by Redhead23; 02-21-2005 at 07:34 AM.

     
    Old 02-21-2005, 08:08 PM   #3
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    Re: ADDERAL taken off Canadian market

    The information I read said 20 deaths in Canada and about 20 more elsewhere.
    From the article I read on the 'net, I gathered that XR was the only one used in Canada and that's why it's the only form mentioned.
    Anyhow, that really is not a lot of people based on the # of scripts but I have a feeling this is just the tip of the iceberg.
    My son went from Concerta to Adderal and said he liked Adderal better as far as helping with his attention but he seemed to get more headaches and complained of dizziness. I think he's finally found his niche because although it's still a struggle for him, he is doing much better is school.
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    Old 02-22-2005, 01:33 AM   #4
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    Re: ADDERAL taken off Canadian market

    Quote:
    Originally Posted by Bosmom
    The information I read said 20 deaths in Canada and about 20 more elsewhere.
    Oh I see - all sources I have found state that none of them were in Canada, it was just a precaution.

    Quote:
    From the article I read on the 'net, I gathered that XR was the only one used in Canada and that's why it's the only form mentioned.
    LOL that might well explain

    Quote:
    Anyhow, that really is not a lot of people based on the # of scripts but I have a feeling this is just the tip of the iceberg.
    My son went from Concerta to Adderal and said he liked Adderal better as far as helping with his attention but he seemed to get more headaches and complained of dizziness. I think he's finally found his niche because although it's still a struggle for him, he is doing much better is school.
    Barb
    I do suspect that as I said above the reason why Adderal seems "worse" than Dex is because it uses 4 different amphetamine salts. Has your son tried Dexedrine? If Adderal works for him it is well possible that Dex (which makes up 1/4 of Adderal) would work as well.
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    Old 02-22-2005, 01:35 PM   #5
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    Arrow Re: ADDERAL taken off Canadian market

    ....deleted.....

    Here is what the US FDA had to say:

    --------------------------------------------------------------------------

    Public Health Advisory for Adderall and Adderall XR

    Health Canada, the Canadian drug regulatory agency, has suspended the sale of Adderall XR in the Canadian market. Adderall XR is a controlled release amphetamine used to treat patients with Attention Deficit Hyperactivity Disorder (ADHD). The Canadian action was based on U.S. post-marketing reports of sudden deaths in pediatric patients.

    Adderall XR is approved in the United States for the treatment of adults and pediatric patients 6 years of age and older with ADHD, and Adderall, the immediate-release formulation of the drug, is approved for pediatric patients with ADHD. The Food and Drug Administration (FDA) has been aware of these post-marketing cases, and evaluated the risk of sudden death with Adderall prior to approving the drug for treatment of ADHD in adults last year.

    OF 12 TOTAL CASES, FIVE OCCURED IN PATIENTS WITH UNDERLYING STRUCTURAL HEART DEFECTS (abnormal arteries or valves, abnormally thickened walls, etc.), ALL CONDITIONS THAT INCREASE THE RISK OF SUDDEN DEATH. SEVERAL OF THE REMAINING CASES PRESENTED PROBLEMS OF INTERPRETATION, INCLUDING A FAMILY HISTORY OF VENTRICULAR TACHYCARDIA, ASSOCIATION OF DEATH WITH HEAT EXHAUSTION, DEHYDRATION and NEAR-DROWNING, VERY RIGOROUS EXERCISE, FATTY LIVER, HEART ATTACK, and TYPE 1 DIABETES MELITUS. One case was reported three to four years after the event and another had above-toxic blood levels of amphetamine. The duration of treatment varied from one day to 8 years. THE NUMBER OF CASES OF SUDDEN DEATHS FOR ADDERALL IS ONLY SLIGHTLY GREATER, PER MILLION PRESCRIPTIONS, THAN THE NUMBER REPORTED FOR METHYLPHENIDATE PRODUCTS, which are also commonly used to treat pediatric patients with ADHD.

    The FDA is continuing to evaluate these and other post-marketing reports of serious adverse events in children, adolescents, and adults being treated with Adderall and related products. WHEN ONE CONSIDERS THE RATE OF SUDDEN DEATH IN PEDIATRIC PATIENTS TREATED WITH ADDERALL PRODUCTS BASED ON THE APPROXIMATELY 30 MILLION PRESCRIPTIONS WRITTEN BETWEEN 1999 AND 2003 (the period of time in which these deaths occurred), IT DOES NOT APPEAR THAT THE NUMBER OF DEATHS REPORTED IS GREATER THAN THE NUMBER OF SUDDEN DEATHS THAT WOULD BE EXPECTED TO OCCUR IN THIS POPULATION WITHOUT TREATMENT. For this reason, THE FDA HAS NOT DECIDED TO TAKE ANY FURTHER REGULATORY ACTION AT THIS TIME. However, because it appeared that patients with underlying heart defects might be at increased risk for sudden death, the labeling for Adderall XR was changed in August 2004 to include a warning that these patients might be at particular risk, and that these patients should ordinarily not be treated with Adderall products.

    Last edited by Administrator; 02-23-2005 at 04:11 PM. Reason: inappropriate comment

     
    Old 02-22-2005, 06:11 PM   #6
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    Re: ADDERAL taken off Canadian market

    ...deleted...
    Here is what the FDA had to say:
    --------------------------------------------------------------------------

    Public Health Advisory for Adderall and Adderall XR

    Health Canada, the Canadian drug regulatory agency, has suspended the sale of Adderall XR in the Canadian market. Adderall XR is a controlled release amphetamine used to treat patients with Attention Deficit Hyperactivity Disorder (ADHD). The Canadian action was based on U.S. post-marketing reports of sudden deaths in pediatric patients.

    Adderall XR is approved in the United States for the treatment of adults and pediatric patients 6 years of age and older with ADHD, and Adderall, the immediate-release formulation of the drug, is approved for pediatric patients with ADHD. The Food and Drug Administration (FDA) has been aware of these post-marketing cases, and evaluated the risk of sudden death with Adderall prior to approving the drug for treatment of ADHD in adults last year.

    OF 12 TOTAL CASES, FIVE OCCURED IN PATIENTS WITH UNDERLYING STRUCTURAL HEART DEFECTS (abnormal arteries or valves, abnormally thickened walls, etc.), ALL CONDITIONS THAT INCREASE THE RISK OF SUDDEN DEATH. SEVERAL OF THE REMAINING CASES PRESENTED PROBLEMS OF INTERPRETATION, INCLUDING A FAMILY HISTORY OF VENTRICULAR TACHYCARDIA, ASSOCIATION OF DEATH WITH HEAT EXHAUSTION, DEHYDRATION and NEAR-DROWNING, VERY RIGOROUS EXERCISE, FATTY LIVER, HEART ATTACK, and TYPE 1 DIABETES MELITUS. One case was reported three to four years after the event and another had above-toxic blood levels of amphetamine. The duration of treatment varied from one day to 8 years. THE NUMBER OF CASES OF SUDDEN DEATHS FOR ADDERALL IS ONLY SLIGHTLY GREATER, PER MILLION PRESCRIPTIONS, THAN THE NUMBER REPORTED FOR METHYLPHENIDATE PRODUCTS, which are also commonly used to treat pediatric patients with ADHD.

    The FDA is continuing to evaluate these and other post-marketing reports of serious adverse events in children, adolescents, and adults being treated with Adderall and related products. WHEN ONE CONSIDERS THE RATE OF SUDDEN DEATH IN PEDIATRIC PATIENTS TREATED WITH ADDERALL PRODUCTS BASED ON THE APPROXIMATELY 30 MILLION PRESCRIPTIONS WRITTEN BETWEEN 1999 AND 2003 (the period of time in which these deaths occurred), IT DOES NOT APPEAR THAT THE NUMBER OF DEATHS REPORTED IS GREATER THAN THE NUMBER OF SUDDEN DEATHS THAT WOULD BE EXPECTED TO OCCUR IN THIS POPULATION WITHOUT TREATMENT. For this reason, THE FDA HAS NOT DECIDED TO TAKE ANY FURTHER REGULATORY ACTION AT THIS TIME. However, because it appeared that patients with underlying heart defects might be at increased risk for sudden death, the labeling for Adderall XR was changed in August 2004 to include a warning that these patients might be at particular risk, and that these patients should ordinarily not be treated with Adderall products. [/QUOTE]




    IMHO, nothing that threatens life is to be considered blown out of proportion. In fact, although instant death may not come to every adult or child alike on Adderall, I would think the obvious adverse cardiovascular effects that can develop over time with amphetamines might make one think of whether or not it's worth it to have heart and vascular health problems in the future.

    Some damages are not instant; they are cumulative. I think one must know what the possibilites are when it concerns their health and well being, then if they choose to take the drugs, hopefully all will be well in their case.

    So, given the damages Adderall can cause, whether now or later, I think it should justifiably be under extreme scrutiny.

    Yes, all drugs including tylenol and aspirin can be dangerous, however, it's the higher levels of danger of some drugs that concerns some people and some governments. Our government is alot more concerned with the captialistic gains than other countries who have socialized programs of medical care.

    I think Canada did the right thing IMHO, and the poster was simply passing on infomation she thought may be important to some parents here....

    Last edited by Administrator; 02-23-2005 at 04:10 PM.

     
    Old 02-23-2005, 12:54 AM   #7
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    Re: ADDERAL taken off Canadian market

    Quote:
    Originally Posted by malibubarbie999
    WHEN ONE CONSIDERS THE RATE OF SUDDEN DEATH IN PEDIATRIC PATIENTS TREATED WITH ADDERALL PRODUCTS BASED ON THE APPROXIMATELY 30 MILLION PRESCRIPTIONS WRITTEN BETWEEN 1999 AND 2003, IT DOES NOT APPEAR THAT THE NUMBER OF DEATHS REPORTED IS GREATER THAN THE NUMBER OF SUDDEN DEATHS THAT WOULD BE EXPECTED TO OCCUR IN THIS POPULATION WITHOUT TREATMENT. !
    That's interesting, isn't it?

     
    Old 02-23-2005, 11:59 AM   #8
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    Re: ADDERAL taken off Canadian market

    Quote:
    Originally Posted by index.html
    That's interesting, isn't it?

    THe FDA said this? What a joke. Type in fda and drug company money and wonder why Vioxx is back on the market or why ever other country bans dangerous drugs that we still sell. We are a highly capitalistic society and money doesn't talk it screams to our government bodies and politicians.

    Look up Daniel E. Troy, chief counsel in the FDA appointed by Bush, was infamous for suing the FDA in defense of various co's to promote off label use,Troy held private meetings with drug manufacturers after heading the FDA. Troy stalled the FDA's investigation of ephedra, despite its link to at least 100 deaths. Troy also sided with the citrus juice industry on new rules to rid fruit juice of contaminants like E. coli.

    When he was not yet appointed to the FDA, Attorney W. Daniel E. Troy defeated the Food and Drug Administration's (FDA) effort to regulate tobacco advertising when he defended Brown and Williamson Tobacco Corporation. Troy won against the FDA again in 1998, so drug companies can provide doctors with information about "off-label" uses of prescription drugs.

    He sided with lobbyists from Fashion Wear Services, a company making decorative contact lenses, allowing the lenses to be regulated as cosmetics instead of as medical devices. Safety advocates criticized Troy's decision because a 15-year-old girl lost sight in one eye from inserting a tinted lens with no professional instruction. Four months later, the FDA reconsidered and banned the import of the lenses citing public health concerns.

    Now, under his rule, the FDA decreased enforcement actions against drug companies. Between January 1999 and December 2001, the FDA sent 90 enforcement letters a year to drug companies using misleading advertising.

    That number dropped to 30 last year, following a change in FDA policy requiring all enforcement letters to win Troy's approval.

     
    Old 02-23-2005, 12:06 PM   #9
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    Re: ADDERAL taken off Canadian market

    Anyway, the whole point to the story is this....we have a right to know the dangers of drugs we give our children in order to make an informed choice.....whether or not the threat is severe, we have a right to know and any warnings should not be swept under by special interests of politicians..our health and children's are at stake.

    This is only IMHO, because each parent makes the choice for their own kids.. It's pretty clear our government will keep the majority of these drugs on the market despite any problems so we should take it upon ourselves to read up on all, negative as well as positive, information that's out there and not let it be brushed off by anyone in power who may or may not have special interests dictating their studies and conclusions....

    Presenting both sides fairly means taking the negative with the positive...I know we all want only the positive, that's human nature I suppose.

    I want to make clear that I am not telling one person here NOT to do what they think is best for their child, and if that is to give them meds so be it..... but please, just be open to all the information out there, that's all.

    Thankyou, Bosmom, for the information.......

    Last edited by Jennita; 02-23-2005 at 12:13 PM.

     
    Old 02-23-2005, 01:37 PM   #10
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    Re: ADDERAL taken off Canadian market

    Well, I can see this has stirred a debate which I had not intended.
    I got my information from a Canadian news website which I consider at least as reliable as our major news sources in the US. I agree there are many different variations of stories on any given subject on the 'net and elsewhere. But my point was simply to report that Canada had found this information serious enough to pull Adderal and Adderal XR off the market until further notice. Apparently, Canada believes in being PROactive and the US believes in being REactive. And in the case of Vioxx, this FDA (the one with the "real" facts-LOL) is putting this dangerous drug back on the market because apparently, it hasn't KILLED enough people for the FDA to be satisfied with.
    I don't care if it's 12, 20 or 40 that Adderal has adversely affected. I care that it was ONE. Someone somewhere has lost a CHILD to this drug. Would 12, 20 or 40 matter to you if that ONE child were YOURS?
    I believe in medicating a child with ADD as a last resort. These types of drugs can be lifesavers for children who have a difficult time learning. But I think before parents put their children on these drugs, they should educate themselves on the pros and cons as well as other forms of treatment.
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    Old 02-24-2005, 10:23 AM   #11
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    Re: ADDERAL taken off Canadian market

    Quote:
    Originally Posted by Bosmom
    Well, I can see this has stirred a debate which I had not intended.
    I got my information from a Canadian news website which I consider at least as reliable as our major news sources in the US. I agree there are many different variations of stories on any given subject on the 'net and elsewhere. But my point was simply to report that Canada had found this information serious enough to pull Adderal and Adderal XR off the market until further notice. Apparently, Canada believes in being PROactive and the US believes in being REactive. And in the case of Vioxx, this FDA (the one with the "real" facts-LOL) is putting this dangerous drug back on the market because apparently, it hasn't KILLED enough people for the FDA to be satisfied with.
    I don't care if it's 12, 20 or 40 that Adderal has adversely affected. I care that it was ONE. Someone somewhere has lost a CHILD to this drug. Would 12, 20 or 40 matter to you if that ONE child were YOURS?
    I believe in medicating a child with ADD as a last resort. These types of drugs can be lifesavers for children who have a difficult time learning. But I think before parents put their children on these drugs, they should educate themselves on the pros and cons as well as other forms of treatment.
    Barb
    Great post Barb! I think good intentioned posts like yours gets misinterpreted as attack, causing defensiveness when all you are doing is presenting another side of the information out there and making people think....

     
    Old 02-24-2005, 10:52 AM   #12
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    Re: ADDERAL taken off Canadian market

    Thanks Jennita! I appreciate your support.
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    Old 02-26-2005, 03:18 PM   #13
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    Re: ADDERAL taken off Canadian market

    It just seems a little cruel to completely ban the drug, because it has helped SO many people, and they will now have to go through withdrawals and get acclimated to another drug which probably won't even work very well. From what I've read on this thread, the deaths only occurred in patients who already had heart problems. Banning the drug from EVERYBODY seems a little over-the-top and ultra-reactionary. I agree with the FDA when they decided to add a warning on the lable for patients with a history of cardiovascular problems to avoid taking this medicine. That way everyone else can still continue taking it. I mean people have died from taking Viagra, but they didn't ban that! (Well, they may have banned it in Canada...I don't know. Did they?)

    Amy

     
    Old 02-28-2005, 09:57 AM   #14
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    Re: ADDERAL taken off Canadian market

    Quote:
    Originally Posted by Bosmom
    I believe in medicating a child with ADD as a last resort. These types of drugs can be lifesavers for children who have a difficult time learning. But I think before parents put their children on these drugs, they should educate themselves on the pros and cons as well as other forms of treatment.
    I couldn't agree more.

     
    Old 02-28-2005, 12:10 PM   #15
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    Re: ADDERAL taken off Canadian market

    Okay, here's something I'd like to discuss. A couple of you have expressed disgust that Cox-2 inhibitors (Vioxx, et al) are back on the market in the US. Since those drugs have come under scrutiny, I've seen countless elderly patients in *a*g*o*n*y* because their arthritis is now essentially untreated. At our age, you have no conception of how agonizing and debilitating arthritis can be. Without that class of drug and Aleve (which is also now considered to be more dangerous), their choices are 1) Tylenol which is ineffective 2)Aspirin with its risks (do you have any idea how many people die each year from GI bleeds?) and 3) prescription narcotic pain relievers.

    So, is it possible - just possible, that's all - that the Cox-2 inhibitors (Vioxx, et al) even with their risks are less risky than putting elderly patients on narcotics to control their pain? Is it possible, just possible, that there were other factors involved in the decision to allow these drugs to be prescribed with restrictions than money alone?

    Now, you want to know what disgusts ME??? That pharmaceutical companies are allow to advertise directly to consumers. I still don't understand THAT decision.

     
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