[Nasional-e] Common painkiller is found to carry some risk of death

[Ambon]

 Common painkiller is found to carry some risk of death

Sheryl Gay Stolberg

The New York Times Saturday, September 21, 2002
SILVER SPRING, Maryland Citing evidence that thousands of patients
unwittingly take toxic - and potentially fatal - doses of acetaminophen, a
panel of expert scientists has urged stronger warning labels for the
painkiller, the main ingredient in nearly 200 over-the-counter cold and
headache remedies, including Tylenol.
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The committee voted nearly unanimously, 21 to 1, to advise the Food and Drug
Administration to adopt the stronger warnings, and the agency typically
follows such advice.
.
The vote Thursday came after agency officials presented evidence that 100
people die and more than 2,000 are hospitalized each year in the United
States as a result of liver damage from unintentional overdoses of
acetaminophen.
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Acetaminophen has been on the market since 1955 and is thought to be the
most widely used pain reliever in the world.
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The current recommended dose is no more than 4 grams a day, or eight
extra-strength pills of 500 milligrams each.
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Experts say anything beyond that is potentially dangerous, and they advise
patients to take the lowest effective dose.
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Yet in some people, particularly those who consume alcohol, even the
recommended dosage can be risky. So acetaminophen labels warn people who
consume three or more alcoholic beverages a day to consult their doctors.
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The numbers of overdose victims are relatively small compared with the
billions of doses of acetaminophen taken each year, and manufacturers insist
that the drug, which is also contained in prescription painkillers like
Percocet and Vicodin, is safe when taken as directed.
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But the committee's chairman, Dr. Louis Cantilena, said the panel was
convinced of the need to reduce the risk.
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He said committee members were "particularly disturbed" to hear that many
consumers mistakenly mixed more than one acetaminophen product because they
failed to realize, for instance, that their prescription painkiller and cold
medicine both contained the drug.
.
The advisers called for every package of acetaminophen to say it contains
the ingredient in bold type, and suggested warnings that taking more than
the recommended dose could cause liver damage - steps that the manufacturer
of Tylenol is already taking. In addition, the committee asked for warnings
to consumers not to use more than one product containing acetaminophen at
the same time.
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The dry statistics of the session Thursday gave way to emotion when a
Pennsylvania mother told the panel how her 23-year-old son had died of an
unintentional overdose of acetaminophen, which he had taken to alleviate
wrist pain.
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"You cannot allow more innocent men, women and children to suffer," the
woman, Kate Trunk, said. "Death is not an acceptable side effect."
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The meeting Thursday was part of a long-awaited review by the Food and Drug
Administration of over-the-counter painkillers.
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On Friday, the panel was to reconvene to consider possible labeling changes
for aspirin and ibuprofen, the main ingredient in drugs like Advil.
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Once the review is complete, the agency can issue final regulations.