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more than a decade's worth of research showing that taking too much of
a popular pain reliever can ruin the liver, the number of severe,
unintentional poisonings from the drug is on the rise, a new study
reports. The drug, acetaminophen, is best known under the brand name
Tylenol. But many consumers don't realize that it is also found in
widely varying doses in several hundred
common cold remedies and combination pain relievers.
These compounds include Excedrin, Midol Teen Formula, Theraflu, Alka-Seltzer Plus Cold Medicine, and NyQuil Cold and
Flu, as well as other over-the-counter drugs and many prescription narcotics, like Vicodin and Percocet.
The
authors of the study, which is appearing in the December issue of
Hepatology, say the combination of acetaminophen's quiet ubiquity in
over-the-counter remedies and its pairing with narcotics in potentially
addictive drugs like Vicodin and Percocet can make it too easy for some
patients to swallow much more than the
maximum recommended dose inadvertently.
"It's extremely
frustrating to see people come into the hospital who felt fine several
days ago, but now need a new liver," said Dr. Tim Davern, one of the
authors and a gastroenterologist with the
liver transplant
program of the University of California at San Francisco. "Most had no
idea that what they were taking could have that sort of effect." The
numbers of poisonings, however, are still tiny in comparison with the
millions of people who use over-the-counter and prescription drugs with
acetaminophen.
Dr. Davern and a team of colleagues from
other centers led by Dr. Anne Larson at the University of Washington
Medical Center in Seattle, tracked the 662 consecutive patients who
showed up with acute
liver failure at 23 transplant centers across the United States from
1998 to 2003.
Acetaminophen
poisoning was to blame in nearly half the patients, the scientists
found. The proportion of cases linked to the drug rose to 51 percent in
2003 from 28 percent in 1998. Not all the poisonings were accidental.
An estimated 44 percent were
suicide
attempts by people who swallowed fistfuls of pills. "It's a grisly way
to die," Dr. Davern said, adding that patients who survive sometimes
suffer profound brain damage.
But in at least another 48
percent of the cases studied, the liver failed after a smaller,
unintentional assault by the drug over several days. "I see some young
women who have been suffering flulike symptoms for the better part
of a week, and not eating much," Dr. Davern said. "They start with
Tylenol, and maybe add an over-the-counter flu medicine on top of that,
and pretty soon they've been taking maybe six grams of acetaminophen a
day for a number of days. In rare cases that can be enough to throw
them into liver failure."
Each Extra Strength Tylenol tablet contains half a gram, or 500 milligrams, of acetaminophen, and
arthritis-strength
versions of the pain reliever contain 650 milligrams. One tablet of
Midol Teen formula contains 500 milligrams of acetaminophen, as does
one adult dose of NyQuil Cold and Flu. One dose of Tylenol Cold and Flu
Severe contains 1,000 milligrams. The recommended maximum daily dose
for adults is 4 grams, or 4,000
milligrams.
"Part of the problem is that the labeling on
many of these drugs is still crummy," said Dr. William Lee, a liver
specialist at the University of Texas Southwestern Medical Center in
Dallas, who for years has been lobbying the Food and Drug
Administration to make manufacturers put "acetaminophen" in large
letters on the front of any package that contains it, so that as they
reach for the bottle, patients will be more likely to pause and keep
track of exactly how much they are swallowing.
Some
companies have voluntarily added new warnings about acetaminophen's
risk to the liver, and they should be given credit for that, said Dr.
Charles Ganley, director of the F.D.A.'s Office of Nonprescription
Products. "But labeling isn't where I would like it to be," Dr. Ganley
added.
McNeil Consumer & Specialty
Pharmaceuticals,
a division of Johnson & Johnson, updated the labeling on all its
Tylenol products in 2002 to list all the active ingredients on the
front of the bottle, increase the type size of acetaminophen, and added
a label on the front warning consumers not to use the product with
others that contain acetaminophen, said Kathy Fallon a spokeswoman.
"I urge consumers to read the label," she said. "Anything more than the recommended dose is an overdose."
Dr.
Lee said he was disturbed by a pattern: "that acetaminophen is always
billed as the one to reach to for safety, probably even more so now,
with other pain relievers pulled from the market."
In fact,
the drug, when given in precise, appropriate doses is safer for
children and teenagers than aspirin, which can interact
with a viral infection to bring on rare but serious damage to the
brain, liver and other organs in a constellation of symptoms known as
Reye's syndrome. And among adults, low doses of acetaminophen are less
likely than aspirin, ibuprofen or naproxen to eat away at the stomach,
aggravate bleeding or harm the kidneys.
Even
patients with chronic liver disease are justly advised to take
acetaminophen for the occasional fever, or for the pain of
osteoarthritis, a back injury or other malady, if they keep the total
daily dose under about two grams, Dr. Lee said.
Experts
agree that a vast majority of people can safely take the four-gram
daily maximum that labels recommend for adults - the equivalent of
eight Extra Strength Tylenol spread across 24 hours - and some people
swallow much more without harm.
But by eight grams in a single day, a significant number of people whose livers have been stressed by a virus,
medication, alcohol or other factors would run into serious trouble,
Dr. Lee said. Without intervention, about half the people who swallowed
a single dose of 12 to 15 grams could die.
How much
alcohol over what time period is problematic? Recent research suggests
the answer isn't simple. The package labels now warn anyone who drinks
three or more drinks every day to consult a doctor before taking
acetaminophen, but Dr. Lee thinks that people who are sober during the
week but binge on weekends may be vulnerable, too.
The few
days of fasting that can accompany a bad stomach bug also seem to
increase the liver's vulnerability to acetaminophen. And though safe
levels of the drug for large men may, in general, be higher than those
for small women, obese people aren't protected; extra fat in the
liver seems to prime the organ for further damage.
Nearly
two-thirds of the people in the transplant center study who
unintentionally poisoned themselves were taking one or another of the
roughly 200 prescription drugs that contain acetaminophen plus an
opiate. Among the most popularly prescribed drugs in this group include
hydroconebitartrate plus acetaminophen, which is commonly sold as
Vicodin, and oxycodone hydrochloride plus acetaminophen, better known
as Percocet.
While these acetaminophen/opiate combination
drugs can be very effective in curbing pain after surgery or injury,
some patients who take the drugs chronically soon find they need
increasing amounts to achieve the same level of pain relief.
Because
the narcotic part of the compound can be addictive, its accompanying
doses of acetaminophen climb sky high in lock step. The liver may keep
pace with gradual increases of the drug initially, only to suddenly
crash months later. It is the
acetaminophen that kills the liver.
Lynne Gong of San
Jose, Calif., watched her 28-year-old daughter, Leah, nearly die last
summer after that sort of crash. What had started out as a treatment
for the pain of a dislocated shoulder and subsequent surgery had
escalated over two years to a full-blown addiction.
After
her daughter was hospitalized, Ms. Gong said she found herself warning
friends, neighbors "and anyone else who would listen" that they needed
to closely monitor their own intake of acetaminophen and that of their
children.
Some dangers lurk in surprising corners. One
day, after Lynne Gong told the women in her prayer group about Leah's
experience, a member went home and, after a little investigating of her
own, discovered that her 12-year-old son and his friends had started
nipping NyQuil on Friday nights for the alcohol content, in hopes of
getting drunk.
There are 9.8 grams of acetaminophen in a 10-ounce bottle of
NyQuil, Ms. Gong said. "Everyone really needs to be more aware."
I
am a person who needs to use marijuana for health reasons. I live in
chronic nerve pain, have RSD, arthritis and fibromyalgia. I have been
to many pain clinics and unfortunately no one has been able to help me.
I am allergic to just about every narcotic pain medication and could
not tolerate seizure drugs that would help stop the nerve firings in my
feet.
