Posted on 02/08/2006 7:38:31 PM PST by Pharmboy
Deaths of 51 U.S. patients who took widely prescribed drugs to treat attention deficit disorder prompted regulators to start watching for heart attacks, high blood pressure and other problems in 2004, a report released on Wednesday said.
The U.S. Food and Drug Administration staff did not say the drugs were responsible for the fatalities, but they urged close monitoring for "the rare occurrence of pediatric sudden death during stimulant therapy."
"These reports themselves do not establish a causal relationship between these medications and cardiovascular adverse events," wrote Dr. Gerald Dal Pan, director of the FDA's Office of Drug Safety, in a separate notice on the agency Web site.
The information was released one day ahead of an FDA advisory panel meeting on how best to study potential risks from the drugs, which include Shire Pharmaceuticals Group Plc's Adderall and Novartis AG's Ritalin.
FDA staff scientists and experts will provide updated information at the meeting about serious health problems that have been reported, the agency said.
Use of drugs to treat attention deficit hyperactivity disorder, or ADHD, was controversial before the cardiac issue emerged, with many doctors and parents arguing the medicines are overprescribed.
The FDA said it decided to seek input from an advisory panel after reports of sudden death, high blood pressure, heart attacks and strokes among some of the millions of adults and children who have taken the medicines.
Through 2003, 24 deaths were reported from 1999 through 2003 among U.S. patients who took Adderall for ADHD, the FDA staff report said. The agency excluded cases that appeared linked to intoxication from multiple drugs or other causes.
Another 16 deaths were reported through 2003 in U.S. patients who took Ritalin or other ADHD drugs known as methylphenidates, the report said. Eleven deaths were reported among other drugs besides Adderall in the amphetamine class, it said.
"Conclusions about the relative safety of these two stimulant therapies cannot be made on the basis of this analysis," the FDA staff said.
Thirty additional deaths of methylphenidate patients were recorded but they were either non-U.S. cases or occurred outside the review period, the report said.
Shire spokesman Matthew Cabrey said data have not shown any correlation between Adderall and the sudden deaths reported among children. He said the company supports the FDA's review of the matter.
Health Canada temporarily suspended Adderall sales last year after 20 reports of sudden death in people who took it. The agency allowed Adderall back on the market after concluding it could not prove the drug was more risky than other therapies.
Novartis said its own review found no increased risk of cardiovascular problems in patients who took methylphenidates compared with the general population.
The FDA also has been studying if ADHD drugs may be related to psychiatric problems.
Republican Sen. Charles Grassley (news, bio, voting record) charged the FDA had taken a "disjointed" approach to the drugs over the past year. In a letter to the agency, the Iowa Republican suggested a "comprehensive" review of all ADHD medicines.
Shares of British firm Shire fell 3.2 percent to 890.2 pence in London trading. Novartis shares gained 5 cents to close at $54.70 on the New York Stock Exchange.
Bump for later.
What bothers me is school districts that require parents to give their kids Ritalin. I know, you can always homeschool your kid, but not everyone is up to it.
I would venture to guess that most of the dead Ritalin users are boys, because it tends to be little boys that the school administrators pick on.
You may possibly be right that there are cases where Ritalin is indicated. I don't know. But I think it is greatly overused.
Incredible at the mass emasculation and neutering of strong-willed individualism, the transformation of pride into self-loathing shame, and the immediate disqualification of ever bearing arms, being a cop or a soldier, or even gaining a required security clearance to sweep floors in a government building.
My mother apparently had some kind of attention deficit drug smear on the back of her hand.
Speed kills.
I personally know of a psycho-quack PhD who prescribed Ritalin to a friend whom he diagnosed with 'adult ADHD' (I would dispute whether such a condition even exists). The fellow was later properly diagnosed with anxiety and depression (which can have very similar symptoms he was told).
He took Ritalin for a couple of years during which his condition only got worse. When he was correctly diagnosed and given a combination of a mild anti-depressant combined with a mood stabilizer, it was as if a miracle had occured. His new doc said that giving someone with an anxiety problem Ritalin is like throwing gasoline onto the fire.
The psycho-quacks today basically treat each patient like a guineapig - they keep trying different medications til they can find one that 'works' (the definition of what 'works' is still up for debate in my view). They have little understanding of what they are doing and what these myriad drugs do to different people - in both short and long-term.
If you go to a psychiatrist for medication you have just self-nominated to be the subject of an ongoing experiment - with often dubious odds of getting better. Certainly many of these medications can have positive uses - but I would wager that mood-affecting drugs are the most over-prescribed family of drugs after anti-biotics. What we are doing to ourselves is truly scary. Just like many boys are prescribed Ritalin because parents/teachers can't handle their being, well - boys - many adults are also given all sorts of psychiatric medications merely because they can't handle life - not because they are sick in any medical sense. Its a 'growth industry' with millions to be made you know.
Just my 2 cents worth.
BTTT
Heh. I don't like that, but neither is it as bad as people pretend.
Uhhh...that's a bit sweeping, and far more than these drugs ever do. What they DO do--when prescribed appropriately--is allow an individual to focus and accomplish. The beauty of these agents is that if they do not work within a few days, stop them.
PhDs cannot precribe. Only MDs can prescribe Ritalin--it is a Schedule II drug which requires a federal license to prescribe.
There really is no such thing. Law prevents school districts from requiring any medical regimen as a prerequisite to educational access.
But there ARE a lot of substandard teachers, administrators, and bureaucrats who believe it is the student's job to make their jobs easier, not vice versa. And where behavior is made "manageable" by drugs, those same shiftless staff will always opt for the easy way out rather than going the extra mile for a needy kid.
I'm 47 yrs old. I've been taking Adderall for 4 or 5 years now for treatment of Adult ADD. It took me years to find a doctor who would or could help me.
It has been a miracle for me. Could I get by without it? Certainly. I did for many years. But frankly, I am more than willing to take this miniscule risk of heart attack for the difference this medication has made in my life. My risks of death are monumentally higher from so many other things.
I sometimes dare to dream about what I could have done in school had Adderall been available to me in those years.
And people must realize the success you have had may not translate to them and/or their children.
Yes...the stigma attached to these agents can impact one's future. I am glad he made it...
You may be right in theory. I believe parents have an absolute right to bring up their kids as they think best, unless they are truly abusive. But there have been plenty of news stories about schools that won't let kids attend unless they take Ritalin.
A lot of parents don't have the time, means, or initiative to homeschool their kids or hire a lawyer to sue the school. So they take the easy way out.
"And people must realize the success you have had may not translate to them and/or their children."
Amen to that. My oldest (FReeper Clarinet_King) was wrongly diagnosed with ADD in elementary school because of lazy teachers and the absence of a CAT scan.
A CAT scan in 2003 because of recurring headaches in college found a softball sized cyst in his left frontal lobe. It is surmised now that the cyst was likely caused by the trauma of child birth and grew slowly for nearly 20 years before being discovered.
Well, your 2 cents are right on. Proscribing these drugs to our children is insane!
Unless the Democrats believe it will create more mind-numbed voters.
Wow.
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