Got this from drudgereport.com
FDA Says Adderall Drug Data Isn't Enough for Recall (Update1)
Feb. 10 (Bloomberg) -- U.S. drug safety reports linking an attention deficit drug to 20 deaths aren't enough for the Food and Drug Administration to follow Canada in taking the product off the market, the agency's director of medical policy said today.
Health Canada ordered the withdrawal yesterday of Adderall XR, made by Shire Pharmaceuticals Group Plc, based on its review of adverse-event reports previously given to the U.S. agency by the Basingstoke, England-based company. The drug is prescribed for children and adults with attention deficit hyperactivity disorder.
``The cases are not convincing evidence the drug is clearly responsible for these deaths,'' said Robert Temple, director of the FDA's office of medical policy, in an interview.
The drug, Shire's biggest product, will remain available in the U.S., its largest market, Temple said. House and Senate committees have been probing the FDA's monitoring of drug safety since antidepressants were linked to increased risk of suicide in children and Merck & Co. withdrew its Vioxx painkiller after a company study tied it to heart risks.
The FDA is deciding whether to conduct its own study of the Shire drug's safety and will closely monitor adverse-event reports, Temple said. In the U.S. about 2 million children have attention deficit hyperactivity disorder, according to the National Institutes of Health.
Shares of Shire, the U.K.'s third-biggest drugmaker, fell the most in a more than a year today. The company's stock dropped 64.5 pence to 577.5 pence at the close of trading in London. The 10 percent drop was the steepest since January 2003.
FDA Discouraged Withdrawal?
``Information conveyed to my staff suggests that during a recent Adderall meeting, one or more FDA employees requested that the Canadian government refrain from suspending the use of Adderall XR because there was concern that FDA could not handle another `drug safety crisis,''' Senate Finance Committee Chairman Charles Grassley, an Iowa Republican, said today in a letter to acting FDA Commissioner Lester Crawford.
Grassley requested details of meetings with Canadian officials concerning Adderall and related records and documents. A phone message left after normal business hours for FDA spokesman Brad Stone for comment on Grassley's letter wasn't immediately returned.
Health Canada ordered the drug to be withdrawn after Shire declined a request to take it off the market voluntarily, said Robert Peterson, head of the agency's therapeutic products division, on a conference call today with reporters. Canadian authorities will further examine details of the safety reports before deciding whether to allow sales to resume, Peterson said.
Adderall XR, the drug's extended-release version, had third- quarter sales of $140 million, more than 40 percent of Shire's revenue for the period. Adderall is an amphetamine, a class of drugs that stimulate the central nervous system.
Shire ``is confident in the safety of Adderall XR,'' and disagrees with Health Canada's conclusions, Shire spokesman Matthew Cabrey said in a telephone interview. About 37 million prescriptions have been dispensed over 10 years, and more than 1 million people have taken Shire's two forms of Adderall, he said.
We're sorry. But Frankie, Just don't make yourself look like such a F'n idiot on here. It's like you're begging for us to abuse you. You and that chump "Rasp". It's just so easy! Anyway, If you're going to say something stupid, just keep it to yourself. Think you can handle that Frankie?
Rasp, I mean Raspoutine... Sweet name chump. I'm actually more of a White Snake/ Guns & Roses kind of guy and my pimples have cleared up so back off. Your post was really funny, "Rasp". Lets have another!
Canada- "Our new leading authority on ADHD"
Way to stir it up. Idiots.
We should pull the troops and send them to Canada. Stupid Canucks! What a good for nothing country. Oh, but thank god for Health Canada. What would we do with out their insight into evidence-based medicine????
Way to put the patient first....
Yet while a drug's potency is often directly related to its risk of side effects, studies have not found significant differences between amphetamines and the other drugs used to treat attention and hyperactivity problems, said Dr. Joseph Biederman, chief of pediatric psychopharmacology at Massachusetts General Hospital. Dr. Biederman estimates that 30 percent to 40 percent of his patients cannot manage their attention problems well without amphetamines; Ritalin and Strattera are not strong enough for them, he said.
"This is not like high blood pressure, where we have many drugs to treat the condition," he said. "We only have three different kinds of drugs, and to lose one of them would cause an enormous amount of suffering."
Dr. Joseph Biederman
Hey franki martini, how is that downtown newark project coming? You and the soprano crew got things under wraps? "Running money", what else have you been running pal? Paint any houses lately?
Franki, i read one story that said there were 13 deaths from ritalin or conceta. 13 vs 20 doesn't equal 5X. For those who don't know concerta is simply the extended release version of ritalin just like our xr.
Problem with trying to understand these products is that so many out there are fanatically against adhd drugs. One web site i encountered insisted that almost 200 people have "been killed" by ritilan use. I don't believe that either.
You are very unpleasant to say the least. I guess you are a young boy with pimples all over your face who dropped out of high school.
Your relexion is a result of watching too much television and not traveling outside of your four bedroom walls; covered with Motley Crew and Metallica posters.
All my congratulations for joining my IGNORE list buddy!
You're really bringing that up? You let us land our planes? Big F'n deal. You didn't have a choice in the matter. I wouldn't be surprised if we got the approval after our planes were already on the ground. And so what if we didn't.... Is your mounted police going to turn us away with their BB guns and billy clubs?
If canada dropped off the face of the map tomorrow I doubt if anyone would even notice. What exactly to do you guys do up there besides play hockey, get drunk with the eskimos, and take safe drugs off the market for no reason at all?
Half the people in your country speak French! Enough Said!
This entire thing is funny. Reality of the Canadian decision is that they DID NOT decide to discontinue the approval of marketing of dextroamphetamine products such as Dexedrine and Dextrostat plus numerous generics. Something to do with l-amphetamine. Crock of crap. Dextroamphetamine is likely responsible for about 90% of the benefit for ADHD.
The number of sudden deaths is also LOWER than that of the general population. One-5 people per 100,000 will drop dead each year for no apparent reason. Good read can be found at www.heartjnl.com http://heart.bmjjournals.com/cgi/content/full/88/4/426?maxtoshow=&HITS=10&hits=1
Full citation is Heart 2002;88:426-431.
You also have to consider what is being done now and the information that is coming to the surface. The Ritalin type drugs - methylphenidate - have more deaths associated with them and there are deaths due to liver toxicity with Strattera. The latter is just now trickling into the media.
If you want to know the numbers, call the companies like McNeil and Novartis (Concerta and Ritalin) and Eli Lilly (Strattera) and demand that they give you the numbers on their drugs. Don't let them persuade you that there aren't deaths with their products...many companies do the "not me" when it is a generic. Ask for the data on the generics and if you don't get satisfaction, keep asking. They know.
First, you are right! I am from Canada! Second, I have been in the U.S. for two years running money. What did I do before that? Worked for a Mutual Fund company that had over $500 million invested in Health Care! Just after that? Venture Capital for pharma reasearch at the U of T. I guess you're right! My experience and contacts mean nothing and I have no idea how this works...
You are also wrong about Canada being in the news in the last 10 years. It's been 3, when we let YOUR planes land at OUR airports and took care of YOUR citizens for 3 days after 9/11...