ADDERAL taken off Canadian market

[Jennita]

...deleted...
Here is what the 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. [/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....

[index.html]

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?

[Jennita]

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.

[Jennita]

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.......

[LuvMyLilDoggie]

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