Panel Recommends Ban on 2 Popular Painkillers

[Renegade]

By GARDINER HARRIS
Published: June 30, 2009

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.

http://www.nytimes.com/2009/07/01/health/01fda.html?em

[VT9]

“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.

So once again the many are punished for the few who are not responsible enough to take care of themselves.

[BirdGuano]

Why not just ban Tylenol if it's so dangerous ?

/rhetorical

There is always aspirin and codeine.

[rc]

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.

This recommendation makes a lot of sense, especially in light of existing regulations.

For children, Tylenol (and generic equivalents) are sold in two concentrations, "Children's Tylon" and "Infant Tylenol". What makes it very counterintuitive, and has probably led to overdoses, is the fact that the "Infant Tylenol" is a significantly higher concentration than the "Children's Tylenol". I guess the reasoning is that for baby, you might not be able to get them to take a teaspoon, but you will be able to get them to take a few drops.

So at 3 in the morning, when you invariably have to administer a dose, it can be extremely confusing.

What makes matters worse is that apparently the current regulations prohibit them from listing a dose for children under 2 years old. So on the "Children's Tylenol", it says that for a 2 year old weighing X pounds, you should give one teaspoon, or whatever, but for children under 2, you should only give it as directed by a physician.

This is not a big problem, because the dose for kids over 2 gives you a reality check that you're giving the right dose. So if it says that the 2 year old should get one teaspoon, you're probably safe if you give the 1 year old one teaspoon.

But if you have only the "Infant" version, there is no indication whatsoever on the package of what the dose should be, because the product is only intended for kids under 2 in the first place. So it says only that you should give as much as recommended by the doctor, which isn't very helpful at 3 in the morning. It would be quite understandable for someone to look at the "Children's" version to get the dose, which would be a significant overdose of the "Infant's" version.

The doctor did give us a copy of the prescribing information, which was about a fifth generation photocopy of a chart prepared by the manufacturer. So it said that for a one year old of X pounds, we should give 1/2 teaspoon of the "children's" version, or three drops of the "infant" version, or whatever. Of course, at 3 in the morning, this paper usually got separated from the bottle.

I finally stopped buying the "infant" version.

But nowhere on the package does it warn you that the "infant" version is stronger than the "children's" version, which seems counterintuitive. And this is compounded by the fact that (presumably because of existing FDA regulations), they don't disclose the proper dose on the bottle.

It seems to me that, at the very least, they should say something like "Use as directed by physician. Do not exceed ___ drops every ___ hours." But having only one uniform concentration does seem like a wise move, especially if they are not allowed to state the dose on the package.

Also, for the "hard stuff", it does make more sense to me to have the acetominophine and the narcotic in two separate pills. When I had some dental work, I was taking a whole slew of pills. Since one of them was vicodin, I wasn't able to take a Tylenol, because then, when the pain got too severe, I wouldn't be able to take the Vicodin. I never figured out why they sold them only in the combined form.

[Potemkin]

“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.”

Dosing compliance by the patient would be one.

Hey, two prescriptions, two co-pays.

Everyone except the patient is happy.

[rc]

Is the active ingredient in Vicodin currently available by itself?

Generic Tylenol is widely available for pennies a dose, so the additional cost is rather negligible.

[CanadaSue]

I'm not sure if hydrocodone is easily available singly. Vicodin yes, hydrocodone - not so sure. Oxycodone IS available as a single drug in various doses.

[Ought Six]

Life Without Vicodin Will Be OK, Doctors Say


Some Patients Worry Over Possible FDA Ban on Drugs like Vicodin

By EMILY FRIEDMAN
ABC News
July 2, 2009

For 22-year-old Jacob Rosenberg, life without his daily dose of Vicodin wouldn't be much of a life at all.

"Before I began taking narcotics two years ago, I would spend my days in bed," said Rosenberg, who has suffered from fibromyalgia and rheumatoid arthritis for five years, and chronic pain for 10. "I was in college and I wasn't capable of doing anything go to classes or go out."

"But since I've been on Vicodin my pain is 80 percent diminished," said Rosenberg. "It gives me the ability to be a normal person."

Rosenberg is one of millions of Americans who fill prescriptions each year for an acetaminophen-based narcotic or combination drugs such as Vicodin or Percocet, the two most popularly prescribed drugs in the country.

But patients like Rosenberg are worried that the solution to their pain may soon be unavailable to them after an expert advisory panel for the U.S. Food and Drug Administration voted earlier this week to ban combination drugs.

The panel's vote came after days of deliberation over ways to reduce the liver damage risk associated with acetaminophens. The panel also voted to keep over-the-counter combination pills containing acetaminophen on the shelves and lower the maximum dosage of these pills.

The panel voted 36 to 1 to recommend a "black box" warning for prescription medications that combine acetaminophen with another drug.

"It's completely unfair to take these drugs away from us," said Rosenberg. "Without them you can't act like a normal person."

Experts Say Hope Is Not Lost Without Combination Drugs

But medical professionals disagree, and say that those suffering from chronic pain will not be left without medication should the FDA decide to heed the advice of the panel.

"There are a lot more drugs out there than are being used," said Dr. Charles Kim, a pain management specialist at Mount Sinai School of Medicine in New York.

"I would tell patients who are panicking over [this vote] to relax, it doesn't mean they're going to take pain medication off the market completely but just that they're thinking about changing certain prescribing patterns to increase safety," said Kim.

More FDA regulation on prescription combination agents as well as more labeling of over-the-counter acetaminophens could help reduce the number of unintended overdoses, according to Dr. Eugene Viscusi, the director of pain management at Thomas Jefferson University in Philadelphia.

Because nearly 42,000 people visit emergency departments each year with acetaminophen overdoses, half of which are accidental, eliminating drugs that aren't clearly labeled to have acetaminophen in them could decrease this number significantly, said Viscusi.

"The problem is not just with prescription narcotics," said Viscusi, "It's their use in combination with over-the-counter drugs."

Eliminating combination drugs would result in patients being able to treat their pain with two different pills, rather than just one. While some may see this as an inconvenience, Viscusi said he's hopeful it might lead to increased awareness about what patients are actually ingesting.

"This would be the best thing," said Viscusi. "If you're taking the acetaminophen separately from your opioid then you know exactly what you're taking."

And as for patients who say nothing else will ease their pain but the acetaminophen-based narcotics, Viscusi says there are other drugs that can help them.

"There will be other drugs, it just may require a little adjustment in thinking for those doctors who consistently prescribe Vicodin and Percocet," said Viscusi.

Other Drug Alternatives

Percocet, for example, could be given to patients by prescribing them Oxycodone which does not include acetaminophen and then instructing the consumer to take Tylenol as well.

Still, Viscusi is advocating for better labeling on over-the-counter drugs in addition the ban of combination agents as well as more education for consumers and medical professionals alike.

Kim agrees with Viscusi and said that with more training and education, doctors will realize the Vicodin and Percocet are not the only options for pain management.

"Many doctors don't readily have the experience or knowledge of prescribing other agents that either reduce the amount of acetaminophen or take it out completely, such as Norco, Roxicodone, OxyIR, OxyFast or hydromorphone," said Kim.

"These can be safely and effectively used on patients with quality of life-dependent needs who many not be candidates for the acetaminophen, yet need the adequate pain relief to function in their daily lives," he added.

But those who would likely be directly affected by an FDA ban on combination drugs patients of chronic pain are still worried.

"This will hurt a huge amount of people who look to those medications to help manage the pain so they can be a productive part of society," said Penney Cowan, the executive director of The American Chronic Pain Association, who has been suffering from chronic pain herself for more than 30 years.

"It will narrow the field even more when it comes to treatment for pain," said Cowan. "There is going to be a point where there just won't be any other options."

"The problem with pain is that we don't see it, and we can't measure it," said Cowan. "People don't understand just how much pain we are in."

[Steel Magnolia]

I think this is a bad idea. Pain is already WAY undertreated in this country for various reasons. Vicodin and percocet are "little guns" in the pain management cornucopia of narcotics. If all that is available is narcotics without the tylenol component, I can see that scaring off a lot of physicians who aren't comfortable with prescribing pure opioids.

[Ought Six]

So destroying peoples' livers is better than retraining doctors on prescribing painkillers?

[SarahS]

As far as I've seen, the "reason" for all the Tylenol in the narcotics was to prevent folks from taking too many. Unfortunately, most people don't even realize that they could overdose on the Tylenol, so it's not much of a preventative. I do think separate formulations would be the answer. It will also be a stickier situation in prescribing these meds. They will not be removed from the market, just reformulated, and gee... guess what... probably at an elevated cost!
Go read the MSDS on Tylenol sometime, it's like the most toxic substance on the planet.

[Sonny]

Ok, So tell me why was acetoemethin put into/with the pain killers in the first place? uH?

because it makes it So safe, duhh!

Oh yeah, thats right, now I remember.

[drummagick]

How hard can it be to change the formulation of Vicodin?

Don't turn on the acetaminophen tap when you're making the pills!

[Arianwen]

Dr. House is gonna be *pissed.*