ADDERAL taken off Canadian market

[LuvMyLilDoggie]

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.
Barb

[Redhead23]

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I am not sure from the wording whether it is "just" Adderal XR or all forms of it that were withdrawn?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

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.

[LuvMyLilDoggie]

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.
Barb

[Redhead23]

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.

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

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.

[malibubarbie999]

....deleted.....

Here is what the US FDA had to say:

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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.