RSS Feed
Adelphi, MD - Panel to FDA: Ban Percocet and Vicodin and Lower Painkiller Dosages |
|
| |
Text Size
|
Adelphi, MD - A federal advisory panel voted narrowly 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.
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.
Johnson & Johnson, Tylenol's maker, released a statement saying it "strongly disagrees with the committee's recommendation," which would likely "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 ignored studies showing doses sold by her members - two pills of 500 milligram each up to four times a day - were safe.
More of today's headlines
“New York City - Spurred by a broad coalition of religious, labor and immigrant groups, the City Council overwhelmingly passed a resolution on Tuesday to add two of the...”
New York City - Despite Bloombergs Objection, City Council Votes for Two Muslim School Holidays
Warsaw - Cornerstone laid for Museum of Polish Jews
Total24
Read Comments (24) — Post Yours »
1
Jun 30, 2009 at 07:51 PM Anonymous Says:
Only 325 milligrams of Tylenol are the crazy, I need at least 3 of 500 milligrams to crack a headache
2
Jun 30, 2009 at 08:15 PM Anonymous Says:
Vicadin was the only pain killer that gave me relief when I broke a bone which could not be put in a cast! If they ban this drug good luck to all those people who break bones that can not be casted!
3
Jun 30, 2009 at 08:12 PM SimchaB Says:
Reply to #1: Try drinking a few cups of water and put an icepack on your forehead. Reducing your stress levels will help also! & Remember the words of the Rema: Tov Lev Mishte Tomid.
4
Jun 30, 2009 at 08:32 PM Babishka Says:
So people who are in chronic pain from arthritis and diabetic neuropathy are supposed to do what? Suffer?
5
Jun 30, 2009 at 08:50 PM Anonymous Says:
“ So people who are in chronic pain from arthritis and diabetic neuropathy are supposed to do what? Suffer? ”
No. They would just take lower doses and learn to live with some minor pain. Its better than liver failure.
6
Jun 30, 2009 at 09:08 PM Anonymous Says:
Most people are not aware of the risks of Tylemol and that the risks appear at doses not that far off the normal doses. Alcohol adds risk. It might pay to look into alternate forms of relief for discomfort. I was astounded at the effectiveness of ice packs on an injured knee, way better than the viox I used and less risky.
7
Jun 30, 2009 at 09:10 PM dannyb Says:
The dangers of acetaminophen (the active ingredient in Tylenol) are very, very, real. There is a partial solution, though, which would let people use it while reducing the risks of liver damage.
Treading lightly on the science here, Tylenol "uses up" a critical amino acid in the liver. If you just take a small dose of acetaminophen, there's enough of it left (it's being constantly produced) to keep you out of trouble. But if you take a lot, or if you've got other problems, or mix it with other drugs (and possibly alcohol) you use up that amino acid and the Tylenol attacks the liver.
Solution: you can take replacements orally and it'll block the bad effects. This is done in hospital emergency departments for Tylenol overdoses, but can also be administered bit by bit at the same time as the painkiller.
Just add it to the capsule, or take it as a supplement. It's name is "n-acetyl-cysteine", often called N-AC, and is over the counter.
Note that, just like with other supplements, there's a lot of mumbo jumbo garbage "hype" about how great it is for everything this side of the kitchen sink, but the acetaminophen "antidote" stuff is real.
8
Jun 30, 2009 at 11:08 PM Anonymous Says:
“ Vicadin was the only pain killer that gave me relief when I broke a bone which could not be put in a cast! If they ban this drug good luck to all those people who break bones that can not be casted! ”
They did not vote to ban Oxycodone (the active ingredient of Percocet) or Hydrocodone (the active ingredient of Vicodin). They now have alternative composites which combine the active ingredient of these drugs with ibuprofen, so the receptor blocking effect of the drugs, combined with what is essentially Advil, would be able to help you without the harmful effects of the acetomenophen. Instead of Vicodin, you would take Vicoprophen.
9
Jul 01, 2009 at 06:02 AM Or... Says:
or they could take out the acetaminophen (which is not a necessary ingredient, its only there to prevent your body from absorbing all the opium and getting you high as a kite) and lower the dose of Heroin they put in (its all the same opiate). that way we can all get high, kill our pain and not our liver.
10
Jul 01, 2009 at 12:17 AM Parent Alert Says:
I work in a high school and students come into the office asking for Tylenol too often. We do not give it but many students and parents are upset. There are definitely children who take Tylenol much too often, usually with parental consent.
This echoes the warnings we have tried to give students and their parents for years. We are not talking about painful injuries like broken bones and arthritis. We are talking about kids who have a headache and need instant relief.
The refuah can be worse than the macah and we should teach our children to use a cold compress, etc. and avoid unnecessary medication.
11
Jun 30, 2009 at 11:52 PM Anonymous Says:
“ Only 325 milligrams of Tylenol are the crazy, I need at least 3 of 500 milligrams to crack a headache ”
From my personal experience motrin or advil work much better for headaches than tylenol. Tylenol will rather break a fever.
12
Jun 30, 2009 at 11:51 PM Shlomo Says:
Before you recommend taking drugs please warn people of potential side efects even though taking it orally makes anaphylaxis unlikely you can still get allergic reactions ;
see following quote ( 3% to 6% of people given intravenous acetylcysteine show a severe, anaphylaxis-like allergic reaction, which may include extreme breathing difficulty (due to bronchospasm), a decrease in blood pressure, rash, angioedema, and sometimes also nausea and vomiting. [5] Repeated overdoses will cause the allergic reaction to progressively worsen.)
13
Jul 01, 2009 at 07:26 AM Anonymous Says:
There's a lot of blatent profiteering in the pharmiceutical industry - and a lot of prescription drugs have folk-medicine bases - as they did during the Civil War, when J&Johnson and other big companies started out - using herbs and traditional folk remedies as 'secret' ingredients. But it's a lot worse than that - many toxic chemicals are pushed today as medicine. Some good articles here: http://www.pharmaceuticalnation.com/
14
Jul 01, 2009 at 07:28 AM Anonymous Says:
sometimes when i get a headache i eat a small box of raisins. my headache usually goes away. it dosen't always work but it does not cause liver damage
15
Jul 01, 2009 at 09:50 AM anonymous Says:
In Europe diabetic neuropathy is being treated {by physicians] with Lipoic Acid and the fact is most OCT are not regulated and every person does not have the same reaction. A person may have a fatty liver or drink alcohol which would enhace the effect of Tylonol
16
Jul 01, 2009 at 09:10 AM Anonymous Says:
If acitaminophen is so dangerous, then why is it still being made?Are there dangers to using motrin? If motrin can do all acitominophen does plus also reduce swelling and is less dangerous, then why do some people choose acitaminophen? I try to avoid taking any pain relievers. Even when I had a fever, I avoided taking motrin until my temperature reached 102.5 and even then tried to keep the dosage low.
17
Jul 01, 2009 at 11:26 AM Anonymous Says:
My mother-in-law passed away from liver problems. As long as I can remember she would take massive doses of Tylenol for any problem. He doctors' never would commit to the cause of her death, but one did tell us how dangerous Tylenol is when taken in large quantities over time.
18
Jul 01, 2009 at 11:54 AM awacs Says:
“ So people who are in chronic pain from arthritis and diabetic neuropathy are supposed to do what? Suffer? ”
No. There are other pain meds. If you need that much acetaminophen, you're using the wrong tool for the job.
"The more codeine, the better you feel."
19
Jul 01, 2009 at 11:53 AM awacs Says:
“ Only 325 milligrams of Tylenol are the crazy, I need at least 3 of 500 milligrams to crack a headache ”
If you need that much, tylenol is not the solution to your problem. You should try advil or the 'scrips instead.
20
Jul 01, 2009 at 01:36 PM been there Says:
Nsaids, such as ibuprofin and naproxin(Aleve) do not affect the liver the way tylenol does, and are more effective at killing pain. However, if taken long term or at high doses, they will destroy your stomach!! ALL medications have side effects. Natural and herbal remedies ALSO have side effects!! I suffer from chronic back pain-nsaids controlled the pain, but damaged my stomach=MORE pain to deal with! Take no medicine lightly.
21
Jul 01, 2009 at 06:14 PM "Government is NOT the solution to our problem, government IS the problem!!" Says:
stupidity. so many millions of people take Tylenol and such a small percentage got sick. I usually take 2 or 3 extra strength Tylenol and if they get rid of extra strength, i will take the same dosage of regular.
22
Jul 01, 2009 at 06:20 PM A Says:
“ They did not vote to ban Oxycodone (the active ingredient of Percocet) or Hydrocodone (the active ingredient of Vicodin). They now have alternative composites which combine the active ingredient of these drugs with ibuprofen, so the receptor blocking effect of the drugs, combined with what is essentially Advil, would be able to help you without the harmful effects of the acetomenophen. Instead of Vicodin, you would take Vicoprophen. ”
Ibuprofen has it's own dangers. It builds up in the body sometimes to toxic levels. It (along with other NSAIDs such as aspirin) increases the risk of stomach bleeding by 2 or 3 times. It can cause renal failure, seizures, low blood pressure, and a myriad of other side effects, some fatal. Of course much of this is due to taking an overdose but isn't that exactly what they're saying about acetaminophine?
23
Jul 06, 2009 at 06:22 PM Mom Says:
Pain management is a critical issue to an active and aging population. All medications and supplements pose some risk to some people. Evaluating those risks is the job of our medical community and pharmaceutical companies. Without the benefit of their educations, practical experience and research, it would be hard for us lay people to determine what amount of "normal dosage" is appropriate to us as individuals, and how long we should take those doses. But we, as consumers, must take some responsibility in managing our health. In my opinion, excess is the problem. And excess is often the side effect of people not thinking clearly because they are in pain. I would advise doctors to closely counsel a patient on how to stage a test of medication, particular to him/her, in order to learn how much of that medication is the effective dose for that individual's particular pain. Should be done EVERY time we experience a new pain and are tempted to take a pain reliever of ANY type. Recommended dosing may actually be counterproductive and part of the problem. Sometimes "more is less". Less can also be significantly cheaper. Logic -- who among us believes he/she is "average"?
24
Sep 12, 2009 at 12:01 AM Anonymous Says:
its funny when people have never lived in chronic pain they are quick to say lets ban oxycondone and every drug that has gotten a bad rep in the media when these people are in severe pain i would like to be the guy that says u cant have that its "addictive" or "don't u know thats bad for u"