johnnymk

http://www.nytimes.com/2009/07/01/he..._r=1&th&emc=th

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.

renovation

i take Excedrin when i get a headache. i have found that it works for the pain most the time. I'm sure it the combination aspirin,acetaminophen,caffeine. it works better a lot of times then the prescribed drugs my M.D. has me take for my cluster headaches. so i know i will be stocking up my med cabinet. I'm grateful that the clusters have subsided for over a year now but they could return as they normally do .i have lived with these massive headaches from the time i was 12 or 14. there no fun at all and i have seen a mass no.of M.D. over them. the last 5-8 years have been the most relaxed they have been over all the years. i have even been omitted in the hospital over the headaches. one bit of advice i know is beware of aspirin in it can eat your stomach and there is aspirin poisoning from taking to much of it. i use to have to be tested all the time due to the vast amount i would take for my headaches.

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Houdini

This is simply stupid, for many reasons.

Tylenol, if taken as directed on the bottle, unless you have hepatitis or liver damage, is generally safe and easier on your stomach than alternatives like ibuprofen or naproxen.

If you follow the directions on the bottle, you will not exceed 4g/day, which is the max reccommended for an adult. If you take more, you're just not following the directions. Almost all over-the-counter meds can be toxic in overdose if one doesn't read the directions.

Re: Vicodin and Percocet - well, yes, they can be abused, but so can hydrocodone (the narcotic in vicodin, often found in cough syrups) and oxycodone (found alone in Roxicodone and in many other med preparations.) However, this article isn't about abuse or addiction, but about the toxic effects of the non-narcotic agent.

In fact, even if prescribed, Percocet, whether it's with 5, 7.5, or 10 mg of oxycodone and usually 325 mg of tylenol, is a schedule II controlled substance, meaning it must be written by an M.D. with a DEA and a CDS number, cannot be called in, cannot have refills, and is limited to 240 pills/month (8/day,) which is still way below the threshold of liver damage.

Of course, if alcohol is involved, or even some other meds, the danger-level of tylenol changes, but banning two perfectly good opioid drugs because of the non-opioid ingredient that ANYONE can buy over the counter? Very stupid.

And yes, this is coming from a guy who deals with tylenol overdoses all the time (intentional, usually,) as I'm the director of a psych ER.

More regulations to protect us from ourselves because some idiots cannot follow directions on prescribed or non-prescribed meds. Restricting meds that are already restricted in the name of protecting people from the thing for which they're not restricted is ludicrous.

H

LPMiller

I agree, Tylenol has been around forever. I don't get why this is a problem now.

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johnnymk

Didn't 60 Minutes have a show concerning the dangers of excessive Tylenol many years ago?