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bhamdave
Threadhead
Reged: 01/11/02
Posts: 971
Loc: U.S.A.
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Decision reflects suspected link between drugs, youth suicide
http://www.msnbc.msn.com/id/5772560/
WASHINGTON - The U.S. Food and Drug Administration plans to update antidepressant labels to reflect studies that suggest a link between the drugs and suicide in youths, but remains cautious about the strength of such ties, according to new documents released on Friday.
The decision comes ahead of the release of a highly anticipated new analysis that FDA reviewers said supported earlier findings that certain antidepressants can increase the risk of suicide in some children and teen-agers.
The new review from Columbia University showed "a statistically significant association of suicidal events with antidepressant drug treatment in short-term pediatric clinical trials for all indications," said FDA reviewer Dr. Andrew Mosholder in his analysis of the data posted on the agency's Web site.
Despite the new analysis, the FDA remained cautious.
"While there are some findings among these data suggestive of an increased risk of suicidality for some of these drugs, there remain some inconsistencies in the results," the agency said in a separate statement.
Still, the FDA said it planned to ensure new labeling for antidepressants would "reflect the most recent information" from the studies and analyses, although the specific wording had not been determined.
Drugs approved based on clinical trials of adults
Antidepressant use in younger patients is part of a larger controversy over prescribing children medicines when most drugs are approved based on clinical trials of adults. Only Eli Lilly and Co.'s Prozac is approved in the United States for children and teenagers.
The FDA grants patent extensions to drugmakers who test products in children, but the companies are not required to make that data public.
The FDA has been reviewing antidepressant data for months but has yet to determine whether the widely used drugs raise the risk of suicide in children and adolescents, and what regulatory action should be taken.
Officials asked New York-based Columbia University to analyze a number of existing studies to determine the level of risk. The documents posted Friday did not include the school's actual study.
Mosholder, a scientist in the FDA's Office of Drug Safety, had previously concluded the drugs posed a suicide risk but was not allowed to present those results to an FDA advisory panel earlier this year. The agency's refusal to allow Mosholder to present his findings is the subject of congressional investigations.
The agency is holding another two-day public meeting in September to discuss the Columbia University study.
In Britain, health officials have advised doctors that except for Prozac they should not prescribe most selective serotonin re-uptake inhibitors, or SSRI, antidepressants for children or adolescents.
The FDA is looking at studies of newer drugs including Prozac, Pfizer Inc.'s Zoloft, Forest Laboratories Inc.'s Celexa, Wyeth's Effexor, Bristol-Myers Squibb's Serzone, Solvay's Luvox, Akzo Nobel's Remeron, and three GlaxoSmithKline Plc's drugs -- Paxil, Wellbutrin and Zyban.
The FDA's documents can be found online.
http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4065b1.htm
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AIDS
It's not YOUR problem (I hope that)
It's not MY problem (I know that)
But it is still OUR problem and WE know that!
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Eeyore27
Old Hand
Reged: 07/05/04
Posts: 401
Loc: Where Misery loves Company U...
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Finally!! It's about time that they started putting warnings on these meds, because far too many people have experienced unpleasant side effects, and unfortunately some have resulted in tragedy.
While I think it's especially important to look into the effects on children and teenagers, they should also be investigating the cases of adults who have been affected from them as well. Too many of us have been guinea pigged with these medications as well, and the warning should extend to everyone. I'm just glad that they're finally acknowledging the subject in general, but it seems as if they're trying to keep us grown ups out of the loop here for some reason. Probably because we're the ones paying the taxes that fund these researches in the first place, not to mention, spending our hard earned dollars on the prescriptions for these medications. Oh well, it's a step in the right direction, at least.
Eeyore
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~ R.I.P. Darrell Abbott 12/08/04
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caramello51
Board Addict
Reged: 09/28/02
Posts: 311
Loc: Alaska
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Prozac saved my life when it first came out, but i've found it is virtually impossible to get off these SSRIs. My son became violent when he was prescribed Paxil and he was 15 yrs old. So they definitely are a mixed blessing. But I feel they've done much more good than harm, at least in my case.
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Eeyore27
Old Hand
Reged: 07/05/04
Posts: 401
Loc: Where Misery loves Company U...
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True, antidepressant meds work differently on different people, it all basically boils down to how it works on that person's brain chemistry and the disorder that's being treated.
IMO, I just feel like some doctors stepped over the lines of ethics with how some of these drugs were being prescribed. It shouldn't be a situation where they have the authority to scribble out a script and play the whole "let's wait and see how it works" game with their patients. You would think that they had to know on some level what the reprocussions of prescribing these meds could be without knowing how it would affect their patients would have occurred to them at some point.
Am I wrong for feeling like some of these doctors just didn't give a rat's behind about how some of these drugs would affect their patients? Sorry if I sound a little bit bitter here, but having gone through disturbing side effects from taking Paxil, Zoloft and Wellbutrin, I just really get heated about the subject in general. My doctor was about as compassionate as a piece of plywood as far as my case was concerned. All she gave a darn about was all the free lunches, concert tickets, club box seats for sporting events and all the free medications she was getting from the pharm companies to endorse and prescribe their products in exchange for all of these perks.
It sickens me to think that this could happen, but it does, and I have firstand knowledge of it because I have 3 sisters in the medical field, 2 of which work for a private practice, that have basically told me how the whole system operates. Doctors who operate like this should be stripped of their licenses, because they're obviously not thinking of their partients best interests, it's all about what's coming to them.
Well now it seems some lawsuits may be coming their way, which is only going to make the price of medications go up even more due to research funding (a double whammy if you factor in our tax dollars), malpractice suits against the doctors involved, and both private and class action lawsuits against the pharmaceutical companies, themselves. They need to understand that what works for some people is not going to work for everyone, any one with common sense would know that, especially a person who has an educational background in medicine should have at least a basic knowledge of what, why and how certain meds should be prescribed.
I'm not buying the BS that they had no idea that instances of violent or suicidal behavior could occur in some patients because that is the whole reason why they have to read medical journals and attend seminars about these products and what the outcomes were from patients participating in clinical trials. The FDA should have stricter policies on what medications are approved, and more importantly what conditions they should be approved for. Warnings of these side effects should be available from the word go, not after X amount of people either commit violent crimes, murder someone or commit suicide. It's just plain ridiculous, as far as I'm concerned.
Sorry for the rant, I'm not trying to flame you or anyone else, but there is something seriously wrong with how the system as it stands right now is operating. It just gets so aggravating to think of how many tragedies could have been prevented if some doctors weren't so quick to diagnose and medicate their patients without thoroughly investigating their cases instead of playing russian roulette with the dispensing of these drugs.
Eeyore
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~ R.I.P. Darrell Abbott 12/08/04
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caramello51
Board Addict
Reged: 09/28/02
Posts: 311
Loc: Alaska
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well, i agree with much of what u say, but bear in mind that doctors are not gods (even if they act as if they were), most of us are just guinea pigs in reality. i went to school with many pre-meds students and cheat, lie, and steal was their ethic. they had to get that grade to get into med school, so i kind of doubt many doctor's actual education, and knowledge.
i can rage about the non-attention of doctors also, i've had 1 friend die because of it, and another just about died because of it, and will never be the same person again.
but i don't want to see a lot of lawsuits over SSRI's. we're all just groping our way towards death... the SSRIs work very well for me, i would be dead if not for them. actually i don't know what i'm trying to say, so i guess i'll just shut up.
 
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Eeyore27
Old Hand
Reged: 07/05/04
Posts: 401
Loc: Where Misery loves Company U...
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Caramello,
I'm glad to hear that SSRI's work for you, but as I said, different medications vary according to the person taking them. You're right about us all being guinea pigs, in a sense, but then again, isn't that what the clinical trials are for? I didn't mean to step on your or anyone else's toes with my posts. It's just a very touchy and frustrating subject for me, personally.
I am very sorry to hear that you lost 2 friends as a result of bad medicine. This is exactly what I'm talking about, doctors should be more aware of what is going on with their patients and just plain care in general about what kind of effects certain medications can have on them.
I don't want the price of medications to rise, either, hell, we pay enough for them as it is. I'm just trying to say that it's because of certain corrupt doctors and their practices, we all wind up suffering in some way or another. For those of us who had bad experiences with antidepressants, that is what we suffered with. For people like you that need to take an SSRI because it's the only effective medication for your condition, you wind up suffering as a result of the negative press, lawsuits, and ultimately, the ever rising cost of these medications.
Eeyore
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~ R.I.P. Darrell Abbott 12/08/04
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