Government Considers Stiffer Warnings on Tylenol
c.2001 The Arizona Republic
Evidence that many Americans may poison their livers by unwittingly
taking toxic doses of acetaminophen has the government considering
whether consumers need stiffer warnings about the popular
It's not the first time acetaminophen, best known by the
Tylenol brand, has drawn federal concern. There are warnings not to take
it if you consume more than three alcoholic drinks, because the
combination can poison your liver.
But the latest worry is about overdoses: taking too much for
too long, or mixing the myriad acetaminophen-containing headache,
cold/flu and other remedies, or just popping extra pills.
Because acetaminophen is non-prescription, people think ``it
must be safe and they take it like M&Ms,'' sighs Dr. William Lee of the
University of Texas Southwestern Medical Center in Dallas.
Lee's data suggest acetaminophen overdoses could be a bigger
cause of liver failure than some prescription drugs recently banned for
liver poisoning, such as the diabetes medicine Rezulin.
He tracked more than 300 acute liver failure cases at 22
hospitals and linked 38 percent to acetaminophen vs. 18 percent of cases
caused by other medications. In a second database tracking 307 adults
suffering severe liver injury - not full-fledged failure - at six
hospitals, Lee linked acetaminophen to 35 percent of cases.
Most were accidents and should have been preventable, Lee
The findings surprised Food and Drug Administration officials,
who this month began investigating how big a risk the painkiller poses
and whether Americans need more explicit warnings to use it safely. They
are even seeking data from Britain, where so many people used
acetaminophen for suicide that British health authorities now restrict
how many tablets are sold at once.
Acetaminophen's liver toxicity ``is conspicuous in its
magnitude compared to some of the other bad players we've taken off the
market,'' says Dr. Peter Honig, the FDA's postmarketing drug safety
chief. ``We're looking at the data to decide if something has to be
Certainly millions of Americans safely take acetaminophen every
day. Tylenol-maker McNeil Consumer Healthcare calls it one of the safest
over-the-counter products and insists liver failure occurs only with
``This is not a casual, `Oops, I took an extra pill,''' a
McNeil vice president, Dr. Anthony Temple, stresses.
Nor is it the first liver warning. The FDA mandates that
bottles bear alcohol warnings after a Virginia man won an $8 million
lawsuit claiming moderate Tylenol doses with his usual dinner wine left
him needing a liver transplant.
And McNeil warns that mixing doses of infant Tylenol drops with
children's Tylenol liquid kills. The two are not interchangeable. Yet
poisonings still occur when parents mix up products and give babies a
potentially deadly teaspoonful instead of a safe dropperful.
For adults, acetaminophen bottles recommend no more than eight
extra-strength pills in 24 hours, and to seek help for overdoses.
Critics want labels to mention liver failure explicitly, saying
consumers don't realize overdosing is easy and dangerous. Lee cites
taking maximum doses for days instead of once or twice, or flu sufferers
taking high doses while not eating. Some rack up the chemical by taking
acetaminophen-containing prescription painkillers such as Vicodin or
Percocet plus over-the-counter headache or cold/flu remedies. Also,
there are reports that smaller acetaminophen doses may overwhelm
On the other hand, some FDA officials worry that too-explicit
warnings could alert potential suicides to the worst doses, causing a
problem such as Britain faced.
To be safe, Lee advises limiting daily acetaminophen to the
amount in four extra-strength pills, 2 grams total from all medicines.
Overdoses can be treated easily if doctors know the culprit in
time. But initial symptoms are flu-like and doctors may not promptly
test for acetaminophen's hallmark sky-high liver enzymes.
Consider Marcus Trunk, 23, who took prescription Tylenol with
codeine for a wrist injury for 10 days and then over-the-counter
acetaminophen for a week. Suddenly fever and vomiting struck. A hospital
gave more acetaminophen before diagnosing liver failure, said his
mother, Kate, of Fort Myers, Fla. He died in a week; an autopsy blamed
Kate Trunk had thought that alcohol was acetaminophen's only
risk and said her son was a teetotaler. Today, her haunting thought:
``If I'd been more educated to acetaminophen products, could I have
steered him clear?''
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