From Public Citizen at http://www.citizen.org
INCREASING NUMBER OF FATAL ACUTE
LIVER FAILURE CASES LINKED TO THE POPULAR PAINKILLER ACETAMINOPHEN (TYLENOL)
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THOUGH VOTED TO BE ELIMINATED, THIS WAS NOT CARRIED THROUGH. THE FDA IS AN ARM OF PhARMA
http://www.msnbc.msn.com/id/31664450/ns/health-more_health_news/
FDA panel votes to eliminate Vicodin, Percocet
Deadly overdoses of acetaminophen, narcotics are cited in recommendation
updated 4:16 p.m. PT, Tues., June 30, 2009
ADELPHI, Md. - Government experts say
prescription drugs like Vicodin and Percocet that combine
a popular painkiller with
stronger narcotics should be eliminated because of their role in deadly
overdoses.
A Food and Drug Administration panel on
Tuesday voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled
off the market.
The FDA has assembled a group of experts to
vote on ways to reduce liver damage associated with acetaminophen, one of the
most widely used drugs in the U.S.
Despite years of educational campaigns and
other federal actions, acetaminophen remains the leading
cause of liver failure in the U.S., according to the FDA.
Panelists cited FDA data indicating 60
percent of acetaminophen-related deaths are related to prescription products.
Acetaminophen is also found in popular over-the-counter medications like
Tylenol and Excedrin.
“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.
Many opposed to
recommendation
But many panelists opposed
a sweeping withdraw of products that are so widely used to control severe,
chronic pain.
“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.
In a separate vote, the panel voted
overwhelmingly, 36-1, that if the drugs stay on the market they should carry a
black box warning, the most serious safety label available.
The FDA is not required to follow the advice
of its panels, though it usually does.
Prescription acetaminophen combination drugs
were prescribed 200 million times last year, according to FDA data. Vicodin is
marketed by Abbott Laboratories, while Percocet is marketed by Endo
Pharmaceuticals. Both painkillers also are available in cheaper generic
versions.
The FDA convened the two-day meeting to ask
experts to discuss and vote on a slew of proposals to reduce overdoses with
acetaminophen. The drug has been on the market for about 50 years and many
patients find it easier on the stomach than ibuprofen and aspirin, which can
cause ulcers.
Panel voted to lower
maximum acetaminophen dose
Earlier in the day,
panelists took aim at safety problems with Tylenol and dozens of other
over-the-counter painkillers. In a series of votes, the panel endorsed lowering
the maximum dose of those products.
FDA’s experts voted 21-16 to lower the
current maximum daily dose of nonprescription acetaminophen, which is 4 grams,
or eight pills of a medication like Extra Strength Tylenol.
The group was not asked to recommend an
alternative maximum daily dose.
The panel also voted 24-13 to limit the
maximum single dose of the drug to 650 milligrams. The current single dose of
Johnson & Johnson’s Extra Strength Tylenol is 1,000 milligrams, or two
tablets.
In a third vote, a majority of panelists
said the 1,000-milligram dose should only be available by prescription.
However, panelists rejected a proposal to
pull certain cold and cough medicines off the market because of their role in
overdosing.
The drugs in question, such as Procter &
Gamble’s NyQuil or Novartis’ Theraflu, combine acetaminophen with other
ingredients that treat cough and runny nose.
The FDA says patients often pair the cold
medications with pure acetaminophen drugs, like Tylenol, exposing themselves to
unsafe levels of the drug.
But panelists cited FDA data that said the
medications play a minor role in acetaminophen overdoses, with only 10 percent
of acetaminophen-related deaths involving a cold and cough product.
“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.
The panel voted 24-13 to keep the products on
the market.
Research published in the December
2005 issue of the medical journal Hepatology found that the annual percentage of potentially fatal acute
liver failure (ALF)
cases caused by acetaminophen (TYLENOL) rose from 28 percent in 1998 to 51 percent in 2003. The research was conducted by
the Division of
Gastroenterology at the University of Washington
Medical Center, Seattle WA.
The facility is part of the U.S. Acute Liver
Failure Study Group (ALFSG), a consortium of 22 academic medical centers
that monitor cases
of liver toxicity around the country.
The ALFSG collected information on all cases of acute liver failure
that occurred between
Jan. 1, 1998 and Dec.
31, 2003, including outcome information. A careful history of each patient's acetaminophen use,
including the total
dose, the type of product used, and the duration of use, was obtained where possible.
The researchers identified a total of 662 patients during the six year
study period who met the criteria
for acute liver failure. Of these 662 patients, in 275 (42%) cases, liver failure was found to have resulted
from acetaminophen-induced liver
toxicity. The fraction
rose from 28% in 1998 to 51% in 2003, almost doubling in five years. The median total
dose of acetaminophen
taken by these patients was 24 grams, the equivalent of 48 extra-strength acetaminophen tablets. Unintentional overdoses were responsible for 131 (48%) of the
acute liver failure cases. Intentional overdoses, or suicide attempts, accounted for 122 (44%) episodes. In 22 (8%) of the cases, the intent was unknown.
Of the 131 patients who overdosed unintentionally, 38% took two or more acetaminophen containing products simultaneously, and 63% used narcotic combination painkillers
that contained acetaminophen. Overall, 178 (65%) of 275 patients identified as having acetaminophen-induced liver toxicity survived. Seventy-four
(27%) died without a liver transplantation, and 23 (8%) patients underwent a liver transplantation operation.
The authors of the
study concluded: “...acetaminophen hepatotoxicity far exceeds other causes of acute liver failure in the United States.” They also stated that efforts
to limit OTC package size and to restrict the prescription of narcotic-acetaminophen combinations (or to separate the narcotic
from the acetaminophen) may be necessary to reduce the incidence of this increasingly recognized but preventable cause of
ALF in the United States. Educational
programs for practicing physicians, pharmacists, and consumers, involving a full discussion of the hazards of this ubiquitous
pain reliever and the identification of susceptible groups, seems warranted.
In testimony before an FDA advisory committee on
this topic more than three years ago, Health Research Group Deputy Director Dr. Peter Lurie
made several similar
suggestions, as well as some others, to reduce the terrible toll of acetaminophen-induced liver failure. That testimony is
available on our web site at http://www.citizen.org/publications/release.cfm?ID=7202.
Drug induced injury or death is a tragedy because, as is the case with
acetaminophen, most
of the time the toxicity of the drugs causing injury or death is known. It is even more troubling when the drug-induced
injury or death is unintentional. In the case of acetaminophen, this can
occur in patients who are taking a prescription
narcotic combined with acetaminophen as directed by their physicians if they also take acetaminophen-containing over-the-counter
(OTC) products. This can happen even if these patients follow the instructions on the label of the product. {What troubles me is the fact that acetaminophen has little if any
medicinal use—it is not an anti-inflamitory like the NSAIDs including aspirin, and it doesn’t dull pain like opiates.
It is a dangerous placebo.—jk}
The amount of acetaminophen contained in OTC drugs is clearly listed on
the label.
Always read these labels before taking any OTC drug to make sure you are not taking acetaminophen (or any other
drug) in more than one product. If you are prescribed a prescription painkiller, it is
likely that it is
a combination of a narcotic drug with acetaminophen. Lortab, Percocet, and Tylox are a few examples
of widely-prescribed acetaminophen-containing painkillers. If you are prescribed a painkiller,
ask your pharmacist
if it also contains acetaminophen. Mixing OTC drugs and prescription painkillers may result in too much acetaminophen
being taken.
Alcohol in combination with acetaminophen can increase the risk of
liver toxicity.
All OTC drugs that contain acetaminophen have the following warning on their labels:
Warnings
Alcohol
warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen
or other pain relievers/fever reducers. Acetaminophen may cause liver damage.
What You Can
Do
To prevent acetaminophen overdose, you should carefully read the labels
on all OTC drug
products to see if they contain acetaminophen. If you are prescribed a prescription painkiller, ask your pharmacist if it
contains acetaminophen.
Do not take OTC products that contain acetaminophen if you are taking an acetaminophen-containing painkiller. Do not take
more than one acetaminophen-containing
drug, prescription or otherwise.
If you or a family member develop any of the symptoms of potential
liver toxicity,
stop taking all acetaminophen-containing products and call your physician immediately. These symptoms are:
* Pruritus (itchy skin)
* Jaundice (yellowing of the skin or whites of the eyes)
* Dark urine
* Upper right-sided
abdominal tenderness (location of the liver)* Unexplained "flu-like" symptoms
