FDA panel: Lower maximum daily dose of Tylenol

June 30, 2009 By MATTHEW PERRONE , AP Business Writer
A bottle of Tylenol, which contains the ingredient acetaminophen, appears with its box wrapper, in Walpole, Mass., Tuesday, June 30, 2009. In a series of votes Tuesday, a Food and Drug Administration panel endorsed lowering the maximum dose of over-the-counter acetaminophen _ the key ingredient in Tylenol, Excedrin and other medications. (AP Photo/Steven Senne)

(AP) -- Government experts called for sweeping safety restrictions Tuesday on the most widely used painkiller, including reducing the maximum dose of Tylenol and eliminating prescription drugs such as Vicodin and Percocet.

The assembled 37 experts to recommend ways to reduce deadly overdoses with , which is the leading cause of liver failure in the U.S. and sends 56,000 people to the annually. About 200 die each year.

"We're here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact," said Dr. Judith Kramer of Duke University Medical Center.

But over-the-counter cold medicines - such as Nyquil and Theraflu - that combine other drugs with acetaminophen can stay on the market, the panel said, rejecting a proposal to take them off store shelves.

The FDA is not required to follow the advice of its panels, though it usually does. The agency gave no indication when it would act on the recommendations.

In a series of votes Tuesday, the panel recommended 21-16 to lower the current maximum daily dose of over-the-counter acetaminophen from 4 grams, or eight pills of a medication such as Extra Strength . They did not specify how much it should be lowered.

The panel also endorsed limiting the maximum single dose of the drug to 650 milligrams. That would be down from the 1,000-milligram dose, or two tablets of Extra Strength Tylenol.

A majority of panelists also said the 1,000-milligram dose should only be available by prescription.

The industry group that represents Johnson & Johnson, Wyeth and other companies defended the current dosing that appears on over-the-counter products.

"I think it's a very useful dose and one that is needed for treating chronic pain, such as people with chronic osteoarthritis," said Linda Suydam, president of the Consumer Healthcare Products Association.

The experts narrowly ruled that prescription drugs that combine acetaminophen with other painkilling ingredients should be eliminated. They cited FDA data indicating that 60 percent of acetaminophen-related deaths are related to prescription products.

But some on the panel opposed a sweeping withdraw of products that are widely used to control severe, chronic pain. Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to the FDA.

"To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake," said Dr. Robert Kerns of Yale University.

If the drugs stay on the market, they should carry a black box warning, the most serious safety label available, the panel decided.

"If we don't eliminate the combination products we should at least lower the levels of acetaminophen contained in those medicines," said Sandra Kewder, FDA's deputy director for new drugs, summarizing the panel's vote.

Percocet and similar treatments combine acetaminophen with more powerful pain relieving narcotics, such as oxycodone.

If the combination products are eliminated, the acetaminophen and the other ingredients could be prescribed separately. In effect, patients would take two pills instead of one, and be more aware of the acetaminophen they are consuming.

Vicodin is marketed by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals. Both also are available in cheaper generic versions.

"The panel recommending banning Vicodin and Percocet seems a little draconian," said Les Funtleyder, an analyst for Miller Tabak & Co.

Drug companies avoided the most damaging potential outcome with the defeat of proposal to pull NyQuil and other over-the-counter cold and cough medicines that combine acetaminophen with other drugs.

These drugs can be dangerous when taken with Tylenol or other drugs containing acetaminophen, according to the FDA, but cause only 10 percent of acetaminophen-related deaths.

"I don't think we should be advocating a solution to a problem that really is not there," said Dr. Osemwota Omoigui, of the Los Angeles pain clinic.

A recall of combination cold medicines would have cost manufacturers hundreds of millions of dollars in revenue. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products, according to IMS Health, a health care analysis firm.

"The acetaminophen people dodged a bullet," said Erik Gordon, a University of Michigan business professor who studies the biomedical industry.

Even with the lower daily dosage recommendation, consumers will likely keep taking as many pills as they think they need to ease their pain, Gordon said.

Analyst Steve Brozak of WBB Securities said the panel votes were a "shot across the bow" of the pharmaceutical industry.

"This basically puts more government oversight into something that heretofore has been less than present," Brozak said.


AP Business writers Stephen Manning and Donna Borak contributed to this report.
©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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3.5 / 5 (2) Jun 30, 2009
This is pointless.

If a person is in bad enough pain, they are going to end up taking whatever amount is needed to stop the pain anyway.
not rated yet Jun 30, 2009
What kind of an article is this? Nowhere does it mention Vicodin. A roundabout case could be made that this recommendation would actually eliminate Vicodin ES which has 750mg per dose, but that's moot since it's prescription. I bet the majority of liver failure cases are from taking too much prescription narcotics that are combined with acetaminophen. The cause being that the combinations they make are designed to be just enough narcotic to provide pain relief for the opiate-naive without destroying their liver. But for someone who has been on painkillers for a while or is trying to get high, it's bye bye liver. They have 80mg doses of Oxycontin, but if you took the same dose in Percocet, you'd be taking 8 grams of acetaminophen and hope somebody was nearby to take you to the ER.
not rated yet Jun 30, 2009
Very mediocre reporting. What is the major incidence of OTC overdose if cold remedies are not it? And why spend all those inches talking about cold medicines if they aren't key? How does overdosing on vicodin/percocet play out? Are most OD patients chronic pain sufferers?
not rated yet Jun 30, 2009
For years now I've been frustrated by all these medications that throw a pain killer into the mix. I have allergies that give me itchy eyes and a runny nose but the pharmacy is stocked with tylenol extra strength allergy and other junk. Similarly with coughs etc. What is wrong with having an anti-allergy or cough medicine WITHOUT a painkiller then letting me chose Tylenol or Advil or Ibuprofin?
1 / 5 (1) Jul 01, 2009
For years now I've been frustrated by all these medications that throw a pain killer into the mix. I have allergies that give me itchy eyes and a runny nose but the pharmacy is stocked with tylenol extra strength allergy and other junk. Similarly with coughs etc. What is wrong with having an anti-allergy or cough medicine WITHOUT a painkiller then letting me chose Tylenol or Advil or Ibuprofin?

Ah, but doctors and pharmacists today take a "Hypocritic Oath" as opposed to the "Hippocratic Oath". Therein lies the answer.

Many of the new medicines today are not designed to cure you, they aren't even designed to treat symptoms, they are designed to make you sick!!

Just look at all the side effects of the crap they advertise on television, calling it "medicine".
not rated yet Jul 05, 2009
Knowledge is power. Unfortunately, there is no time to provide patients or parents or the chronically ill instruction. That time is money after all.

There are actually people who have documented and clinical support of very painful/progressive disease processes for which pain relief is highly regulated and monitored. Everything from vexing painful problems of MS, diabetic neuropathy, inflammatory diseases, the list is LONG. The addition of Tylenol to these medications complicate what are already complex problems, in particular those who take immuno-suppressive medications that already challenge their livers and for which there is no cure. There are few choices to decrease the intake of Tylenol in addition to these pain relievers save pure opiates that are reserved for the most severe pain and problems, like end-stage diseases. This class of medication provide a quality of life that otherwise would be significantly reduced. Even without this new FDA consideration, restrictions are punishing and focused on the wrong people (as usual).

Its sad, those who abuse these drugs have made life for those who need it, aren't seeking a 'high' and WON'T get one because of the physiological path ways in pain relief, miserable. The hoop jumping for those who aren't abusing is punishing and time consuming not only for the patients but also for the prescribing physicians/staff. The DEA and FDA have created a counter-productive problem in their attempt to prevent access to abusers. The addiction rate for those with these problems is 1% or less but are treated as criminals none the less, choices for pain relief options are highly limited now. Its like bad drivers, they are the ones that get the attention and are seen, the good drivers aren't.

If the FDA bans an entire class of pain relievers for those who are chronically ill without providing less limiting availability of effective pain relief without acetaminophen, you can expect increased hospitalizations, increases in suicides and suicide attempts, increases in liver damage or other complications in taking large amounts of other OTC pain relievers like naprosyn and ibuprofen which will be their only recourse in seeking relief of unremitting and vexing painful conditions, clinically supported, that are not cured by diet and exercise. If these other medication provided pain relief, they would be used but they don't for all too many-so this group of people will take bottles at a time trying to produce pain relief.

Opiates that are used wisely and under a physicians directive provide a quality of life that otherwise would be unacceptable. The press and media focus on those who abuse adding to the perception that anyone in chronic pain is likely an abuser. Celebrities and those with money have always had and will always have access to pain relievers while those in real need, options are highly limited. While there are those who do abuse, those are the ones which require the attention, not those who are in genuine need. Denying them will produce negative results and increases in health care costs. Never mind the profound negative impact of daily life of these people.

The FDA failed its mandate in numerous ways. Don't fail again in submitting draconian rules on top of already draconian rules which will produce even more suffering of those that have been failed already.

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