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   ADDERAL taken off Canadian market (ADD - Attention Deficit Disorder board)

1st March 2005
[QUOTE=index.html]Jennita, forgive me here, but I'm just not following your point about off-label uses of prescription drugs.

Well, because off label can be dangerous/inappropriate/experimental. Neurontin makers have been prosecuted for such actions in the past; it was off-label, vigorously pushed for in conditions like anxiety and bi-polar although it's only real theraputic use is for neurological pain and seizures.

Many people became suicidal on it among other nasty side effects and it also caused bi-polar people to have severe problems because it was not effective like the standard treatments. The class action lawsuit is starting now after the guilty verdict.

Other drugs are promoted in simular ways if they find out that a drug has a side effect that might work on another condition the drug wasn't developed for. Another good example is the use of antipsychotics on non-psychotic people for anxiety; seems to me the potentially dangerous side effects(tardive dyskinesia among others) of those stronger drugs isn't even considered now.

I think sometimes things go ok but they are playing with fire.
2nd March 2005
Quote from Jennita:
Well, because off label can be dangerous/inappropriate/experimental. Neurontin makers have been prosecuted for such actions in the past; it was off-label, vigorously pushed for in conditions like anxiety and bi-polar although it's only real theraputic use is for neurological pain and seizures.

Many people became suicidal on it among other nasty side effects and it also caused bi-polar people to have severe problems because it was not effective like the standard treatments. The class action lawsuit is starting now after the guilty verdict.

Other drugs are promoted in simular ways if they find out that a drug has a side effect that might work on another condition the drug wasn't developed for. Another good example is the use of antipsychotics on non-psychotic people for anxiety; seems to me the potentially dangerous side effects(tardive dyskinesia among others) of those stronger drugs isn't even considered now.

I think sometimes things go ok but they are playing with fire.



I take adderall for an "off-label" use. My psych prescribed ot to me in addition with a great mood stabilizer for bi-polar disorder. After trying other anti-depressents it is the only thing that has worked for immediate relief of some serious depression, which would kill me a lot quicker than the adderall. According to him adderall is much safer than regular anti-depressants, and its effects (short term and long-term) have been studied far more extensively than most prescription drugs on the market today.
3rd March 2005
[QUOTE=index.html]Okay, that's where I thought you were going. To some extent, I share your concern. You often hear sales reps from the pharmaceutical companies saying to physicians "Many of my docs are now using drug W to treat XYZ and they are having good results". And some docs, a minority probably but some, go and prescribe it that way strictly based on what they hear the reps say. That's scary.

HOWEVER, we don't want to throw the baby out with the bath water. A good example is aspirin. For many, many years daily low dose aspirin was prescribed "off label" to prevent additional heart attacks in MI patients. Now, that's "on label" but instructing paramedics to give an aspirin sublinqual to a patient experiencing an MI to reduce the damage from that MI is not. I tell you what. If they come after me, they better give me that dang aspirin (if I haven't already taken it myself).

The problem is the number of years and expense involved in acquiring FDA approval for an additional usage. When physicians notice astounding results with these off-label usages and the results are confirmed in small studies, it's unethical for that information NOT to be shared. It borders on malpractice to withold that treatment from patients while the lengthy double-blind studies are carried out and FDA approval is sought.

But, again, caution is essential.

I agree with you to some extent, I think it really depends if indeed they do get good/excellent results in off label use and if the drug's safety/or side effects profile is modest enough to not cause perhaps a larger problem in patients.

In the case of Neurontin, it caused some users to become suicidal not to mention alot of other nasty effects, and they knew it was non-effective for bi-polar yet pushed it for bi-polar patients which caused some of them to experience severe bi-polar reactions since the drug did nothing for their condition. Neurontin makers were found guilty in a court of law of using one of their reps who happened to have a degree in chemistry as a tool to persuade doctors to believe he was a doctor himself and very qualified to determine whether or not Neurontin was for those patients....they did mislead doctors....the rep later worried about his own participation consequence in this went to a lawyer for help who instructed him to blow the whistle.

I believe there is a class action lawsuit going on right now.

Anyway, of course, in the case of a drug with modest risks and great success in off-label uses, I would of course agree with you there.

But after things like the Neurontin scandel, how much can we or even our doctors trust drug co's and their "studies" that convince us to use a drug off label? THere is not always a whistleblower available in most cases.

Caution, yes, extreme caution we must use and with a suspicious eye....
3rd March 2005
I guess our personalities are different, Jennita. I don't look at the Neurontin scandal and come to the conclusion that we can't trust our doctors, pharmaceutical companies, the FDA, and scientific researchers in this country.

Am I alarmed by recent news? Sure, I am. I'm more skeptical than I've ever been in my life. Skeptical, yes. But paranoid? No.
3rd March 2005
[QUOTE=index.html]I guess our personalities are different, Jennita. I don't look at the Neurontin scandal and come to the conclusion that we can't trust our doctors, pharmaceutical companies, the FDA, and scientific researchers in this country.

Am I alarmed by recent news? Sure, I am. I'm more skeptical than I've ever been in my life. Skeptical, yes. But paranoid? No.

I'm not at all suggesting we become paranoid about this at all, I know alot of good work is being done in the medical profession.....but we can be suspicious and cautious..by all means yes! We have to be more active in researching, we can't allow ourselves to always follow along without any investigation or question anymore. Especially in regard to newer drugs and off label usages.

Even more into "alternative" or dietary, reasoning wouldn't hurt us either. For example, I took my daughter to several doctors when she had unexplained, regular bouts with stomach pain. After exams and blood tests, all they could conclude was IBS....the catch all diagnosis...or maybe acid reflux. Problem is, she really didn't have all the symptoms associated with those.

She did try the Zantac prescribed to her but it gave her the runs, she got frustrated and went on the internet. She found a recently new discovery of something called Fructose intolerance, very much like Lactose intolerance but it was a sensitivity not to milk sugars but fructose(fruit) based sugars.

Well, I'm not into self diagnosis entirely but since we already went to the doctors with no avail, I didn't protest when she thought she'd try the diet. Well, it really worked for her. So, there is more to some things that even our doctors know so we need to realize that although they are are good line of defense, they still don't have all the answers.

But by all means, I"m not saying they don't have any answers. Most times they do, they save lives and cure ailments. That same daughter needed eye muscle surgery at a very young age to save the site in her lazy eye....it did save her eyesight and straightened that wandering eye....so, I do have alot of respect for the medical profession as a whole...
 
 

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