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Old 06-30-2009, 07:37 PM   #1
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Panel Recommends Ban on 2 Popular Painkillers

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ADELPHI, Md. ? A federal advisory panel voted narrowly on Tuesday to recommend a ban on Percocet and Vicodin, two of the most popular prescription painkillers in the world, because of their effects on the liver.

The two drugs combine a narcotic with acetaminophen, the ingredient found in popular over-the-counter products like Tylenol and Excedrin. High doses of acetaminophen are a leading cause of liver damage, and the panel noted that patients who take Percocet and Vicodin for long periods often need higher and higher doses to achieve the same effect.

Acetaminophen is combined with different narcotics in at least seven other prescription drugs, and all of these combination pills will be banned if the Food and Drug Administration heeds the advice of its experts. Vicodin and its generic equivalents alone are prescribed more than 100 million times a year in the United States.

Laureen Cassidy, a spokeswoman for Abbott Laboratories, which makes Vicodin, said, ?The F.D.A. will make a final determination and Abbott will follow the agency?s guidance.?

The agency is not required to follow the recommendations of its advisory panels, but it usually does.

The panel?s 20-17 vote to recommend a ban on the combination drugs was one of 11 it took at a meeting called to advise the F.D.A. on problems arising from the extraordinary popularity of acetaminophen. In 2005, American consumers bought 28 billion doses of products containing the ingredient.

While the medicine is effective in treating headaches and reducing fevers, even recommended doses can cause liver damage in some people. And more than 400 people die and 42,000 are hospitalized every year in the United States from overdoses.

In hopes of reducing some of these accidents, the committee voted 24 to 13 to recommend that the F.D.A. reduce the highest allowed dose of acetaminophen in over-the-counter pills like Tylenol to 325 milligrams, from 500. And members voted 21 to 16 to reduce the maximum daily dosage to less than 4,000 milligrams.

But they voted 20 to 17 against limiting the number of pills allowed in each bottle, with members saying such a limit would probably have little effect and could hurt rural and poor patients. Bottles of 1,000 pills are often sold at discount chains.

?We have no data to show that people who overdose shop at Costco,? said Dr. Edward Covington, a panel member from the Cleveland Clinic Foundation.

Dr. Lewis S. Nelson, a toxicologist from the New York University School of Medicine who served as the panel?s acting chairman, said experts had been warning of the dangers of combination painkillers like Percocet, which is made by Endo Pharmaceuticals, and Vicodin for years.

Still, the recommendation is likely to come as a shock to many patients, who may be unaware of the dangers of high doses of acetaminophen ? even if they know the drugs contain the ingredient.

Some doctors already avoid prescribing pills that combine acetaminophen with narcotics like oxycodone (found in Percocet) and hydrocodone (in Vicodin).

?It ties the doctor?s hands when you put the two drugs together,? said Dr. Scott M. Fishman, a professor of anesthesiology at the University of California, Davis, and a former president of the American Academy of Pain Medicine. ?There?s no reason you can?t get the same effect by using them separately.?

Dr. Fisher said the combinations were prescribed so often for the sake of convenience, but added, ?When you?re using controlled substances, you want to err on the side of safety rather than convenience.?

Still, some doctors predicted that the recommendation would put extra burdens on physicians and patients.

?More people will be suffering from pain,? said Dr. Sean Mackey, chief of pain management at Stanford University Medical School. ?More people will be seeing their doctors more frequently and running up health care costs.?

In a statement, Johnson & Johnson, Tylenol?s maker, said it ?strongly disagrees? with the proposed restrictions on acetaminophen, adding that they would be likely to ?lead to more serious adverse events as consumers shift to other over-the-counter products,? like Advil and aspirin.

Linda A. Suydam, president of the Consumer Healthcare Products Association, said the committee had ignored studies showing that doses sold by her members ? two pills of 500 milligrams, up to four times a day ? were safe. ?I think this is a very effective dose and one needed for individuals who experience chronic pain,? she said.

The committee also turned its attention to over-the-counter children?s medicines containing acetaminophen, voting 36 to 1 to limit them to a single formulation. Right now the liquids are sold in two different concentrations, leading to confusion among doctors and parents.

?I don?t think it?s safe to have two formulations out there,? said Dr. Nelson, the acting chairman.

The members were divided over which formula to recommend, the concentrated or the less concentrated one. F.D.A. officials suggested that they would likely settle on the less concentrated formula so that if parents make a mistake, they would be less likely to overdose.

Acetaminophen is included in a vast array of over-the-counter cough and cold products, including Nyquil, Excedrin and many others. A small share of accidental poisonings result when people take two or more of these combination products without understanding the risk.

The F.D.A. asked the committee whether it should ban combination products that include acetaminophen. The vote was 24 to 13 against such a ban, with many members saying consumers saw the products as valuable.

?Based on the data provided, the combination O.T.C. medications really contributed very little to overall poisonings,? said Dr. Osemwota A. Omoigui, a panel member from the Los Angeles Pain Clinic.

A 2005 study found that most poisonings resulted from patients? taking Vicodin and similar products that combine a narcotic with acetaminophen.

?I think this is the one place where we can engineer in safety,? said Dr. Judith M. Kramer, a panel member and an associate professor of medicine from Duke University Medical Center who voted to ban the combination prescription medicines. ?We?re here because there are inadvertent overdoses that are fatal, and this is our one opportunity to have a big impact.?

Consumers need to be better educated about the risks of popular medicines, most panel members agreed.

?If you keep track of what you?re taking, none of this is an issue for you,? Dr. Jan Engle, a panel member and head of the Department of Pharmacy Practice at the University of Illinois in Chicago, said in an interview after the meeting.

Donald G. McNeil Jr. contributed reporting from New York.
http://www.nytimes.com/2009/07/01/health/01fda.html?hp
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Old 06-30-2009, 07:38 PM   #2
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the vicodin would do some good...

i think they should ban oxies first... people treat those fuckin things like crack rocks...
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Old 06-30-2009, 07:39 PM   #3
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Good, I always tell people how bad tylenol and painkillers with it included are.

Apparently if you O.D on tylenol it will take a couple weeks to kill you slowly. [talking bottles at once here]
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Old 06-30-2009, 07:41 PM   #4
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Oh, sure, take away the working white man's self-medicating drug of choice and there will be a revolt.
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Old 06-30-2009, 07:41 PM   #5
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Old 06-30-2009, 07:53 PM   #6
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Oh damn there goes my mojo, anyone know of anything I can replace it with?

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Old 06-30-2009, 10:30 PM   #7
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Oh damn there goes my mojo, anyone know of anything I can replace it with?
healthy active life.
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Old 06-30-2009, 10:33 PM   #8
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I sure miss ludes Lemmon 714 or Rorer 714
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Old 06-30-2009, 10:37 PM   #9
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Percocet and Vicodin arn't shit

ban oxycodone and oxycotin
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Old 06-30-2009, 10:39 PM   #10
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oh well....
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Old 06-30-2009, 10:48 PM   #11
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healthy active life.
Get real; that's not an option.
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Old 06-30-2009, 10:48 PM   #12
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Percocet and Vicodin arn't shit

ban oxycodone and oxycotin
Does anyone here think about anything other than the use of meds to get high?

My wife is one of millions of people who suffer from chronic, debilitating pain.
She needs meds like oxycodone in order just to be able to get out of bed, get downstairs and make breakfast for our daughter every morning without collapsing on the floor in tears from the pain.
Because people abuse medications, that's no reason to ban them.
I normally don't care if people want to kill themselves with addictive medications because they think it's a cool high --- but if the alternative is to ban those drugs and make them unavailable to the people who *need* them --- I'm totally in favor of enforcing the laws against their abuse and throwing people's asses in prison for it.

No one wants to ban cars --- OR drinking --- because people drive drunk and kill other people. But because some jerks abuse drugs that some people need ---- the answer is to ban the drugs? That's pathetic.
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Old 06-30-2009, 10:57 PM   #13
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I'm all for banning acetaminophen, it tears up my stomach and makes me not want to take painkillers even when I need them.
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Old 06-30-2009, 11:24 PM   #14
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I'm all for banning acetaminophen, it tears up my stomach and makes me not want to take painkillers even when I need them.
Then just don't take painkillers with acetaminophen in them?
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Old 07-01-2009, 12:53 AM   #15
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Actually it would effect Tylenol as well if I'm not mistaken that would mean the over the counter drug would become effected as well.
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Old 07-01-2009, 12:55 AM   #16
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Percocet and Vicodin arn't shit

ban oxycodone and oxycotin
Maybe I am wrong here but isnt oxycodone the actual name for percocet? I just took a vicodin 10 minutes ago. I had my wisdom teeth pulled last week and now have this bullshit called dry sockets. I am all for banning that shit just as long as its after I get through this nonsense..
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Old 07-01-2009, 03:02 AM   #17
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too many people use these drugs for them to get banned, seriously
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Old 07-01-2009, 03:18 AM   #18
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Massive impact on dentistry too. It's gonna suck to have a tooth removed. Vicodin/Percocet are highly effective for post oral surgery pain.
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Old 07-01-2009, 03:45 AM   #19
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Does anyone here think about anything other than the use of meds to get high?

My wife is one of millions of people who suffer from chronic, debilitating pain.
She needs meds like oxycodone in order just to be able to get out of bed, get downstairs and make breakfast for our daughter every morning without collapsing on the floor in tears from the pain.
Because people abuse medications, that's no reason to ban them.
I normally don't care if people want to kill themselves with addictive medications because they think it's a cool high --- but if the alternative is to ban those drugs and make them unavailable to the people who *need* them --- I'm totally in favor of enforcing the laws against their abuse and throwing people's asses in prison for it.

No one wants to ban cars --- OR drinking --- because people drive drunk and kill other people. But because some jerks abuse drugs that some people need ---- the answer is to ban the drugs? That's pathetic.
I agree absolutely
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Old 07-01-2009, 05:08 AM   #20
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you americans and your pill popping habits..... a life without pills is much more healthy. Well i live unhealthy as fuck but if i would pop daily pills id be even more unhealthy
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Old 07-01-2009, 07:18 AM   #21
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Just don't allow medicine works for you.
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Old 07-01-2009, 07:45 AM   #22
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Well, perhaps you are right )
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Old 07-01-2009, 07:49 AM   #23
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I already avoid them, I prefer to use alcohol to destroy my liver...lol
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Old 07-01-2009, 07:49 AM   #24
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As long as they legalize marijuana it will all balance out :-)
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Old 07-01-2009, 07:56 AM   #25
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Old 07-01-2009, 08:07 AM   #26
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the vicodin would do some good...

i think they should ban oxies first... people treat those fuckin things like crack rocks...
As far as the oxies go, I agree 100%. In fact I was hopeing that oxies would be one of the two recommended.
But Percocet and Vicodin?????????? WTF?

I can think of a time or two in my life that without Vicodin, I would have been in more pain then I could stand. Also, I can think of 5 or 6 other commonly abused pills that need banned way before Percocet and Vicodin.
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Old 07-01-2009, 08:16 AM   #27
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Then just don't take painkillers with acetaminophen in them?
ya I don't see how selfish people can be saying that stuff that THEY personally dislike or can't use should be banned. For myself, acetominophin is the only kind of painkiller I can use at all aside from the hard stuff like oxy or percs because of my genetic bleeding disorder. If I had to take motrin, advil, or aspirin, I could bleed to death internally, so my options are limited.
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Old 07-01-2009, 08:17 AM   #28
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Maybe I am wrong here but isnt oxycodone the actual name for percocet? I just took a vicodin 10 minutes ago. I had my wisdom teeth pulled last week and now have this bullshit called dry sockets. I am all for banning that shit just as long as its after I get through this nonsense..
Percs are acetominophin mixed with oxycodone.
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Old 07-01-2009, 08:22 AM   #29
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Guess it's straight to metadone.
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Old 07-01-2009, 08:26 AM   #30
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Percs are acetominophin mixed with oxycodone.
I never knew that. But it would have to be a pretty small amount of oxie in there, right?

I have been prescribed both by a doctor, and the oxie was 20mg. It fucked me up. I didn't like it at all. The perc didn't fuck me up like the oxy did. It took away the pain, but didnt make me feel like I was on heavy drugs.
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Old 07-01-2009, 08:27 AM   #31
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I already avoid them, I prefer to use alcohol to destroy my liver...lol
hear! hear!
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Old 07-01-2009, 08:29 AM   #32
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Old 07-01-2009, 08:36 AM   #33
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I know, we rather pop 28 billion of those annually) what can be better))))
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Old 07-01-2009, 08:40 AM   #34
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you americans and your pill popping habits..... a life without pills is much more healthy. Well i live unhealthy as fuck but if i would pop daily pills id be even more unhealthy
Not all of us..
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Old 07-01-2009, 08:51 AM   #35
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Old 07-01-2009, 09:02 AM   #36
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What a joke, MJ dies and amidst all the speculation and drug drama theres a sudden movement to ban vics and percs.. Oxycontin kills more people yearly its not even funny. Misuse is rampant with oxycontin. Its like when the govt moved attention off afghanistan to iraq. Wtf?!
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Old 07-01-2009, 12:36 PM   #37
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What a joke, MJ dies and amidst all the speculation and drug drama theres a sudden movement to ban vics and percs.. Oxycontin kills more people yearly its not even funny. Misuse is rampant with oxycontin. Its like when the govt moved attention off afghanistan to iraq. Wtf?!
Yea, oxies are BAD!!!

sure people use them properly, but ill bet the abuse percentage is much higher.

People truly treat and sue oxies like crack. When they first became widely available and popular back in 2000 or so... I watched my best friend smoke those things off of a piece of tinfoil and a pen. Paying 80 dollars for an 80ml pill and then smoke it witht he guy he bought it from.

Needless to say I did stick around that shit. I got him off of them for about two weeks but I still left. I believe he got back into them. I know he isnt doing them now since I have since seen him and he no longer lives that lifestyle. But it still fucked him up. At the time of using them, really bad.

Ive seen others so whacked out on them that they are truly in a heroin haze.... You cant talk to them or get their attention.

Im so glad i dont see that shit every day anymore
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Old 07-01-2009, 12:41 PM   #38
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What a joke, MJ dies and amidst all the speculation and drug drama theres a sudden movement to ban vics and percs.. Oxycontin kills more people yearly its not even funny. Misuse is rampant with oxycontin. Its like when the govt moved attention off afghanistan to iraq. Wtf?!
Yea, oxies are BAD!!!

sure people use them properly, but ill bet the abuse percentage is much higher.

People truly treat and use oxies like crack. When they first became widely available and popular back in 2000 or so... I watched my best friend smoke those things off of a piece of tinfoil and a pen. Paying 80 dollars for an 80ml pill and then smoke it with the guy he bought it from.

Needless to say I did stick around that shit. I got him off of them for about two weeks but I still left. I believe he got back into them. I know he isnt doing them now since I have since seen him and he no longer lives that lifestyle. But it still fucked him up. At the time of using them, really bad.

Ive seen others so whacked out on them that they are truly in a heroin haze.... You cant talk to them or get their attention.

Im so glad i dont see that shit every day anymore
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