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FDA says Tylenol and alcohol a bad mix

BY THE MICHIGAN DAILY

Published March 27, 2001

The Washington Post

WASHINGTON Evidence that many Americans may poison their livers by unwittingly taking toxic doses of acetaminophen has the government considering if consumers need stiffer warnings about the popular over-the-counter painkiller.

Its 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 nonprescription, "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.

Lees 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, versus 18 percent of cases caused by other medications. In a second database tracking 307 adults suffering severe liver injurynot full-fledged failure at six hospitals, Lee linked acetaminophen to 35 percent of cases.

"Most were accidents and should have been preventable," Lee contends.

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 even are 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.

"Acetaminophens 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, FDAs postmarketing drug safety chief.

"Were looking at the data to decide if something has to be done, and what."

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 substantial overdoses.

"This is not a casual, "Oops, I took an extra pill,"" stresses McNeil vice president Dr. Anthony Temple.

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 up 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 teaspoon-full instead of a safe dropper-full.

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 like Vicodin or Percocet plus over-the-counter headache or cold/flu remedies.

Also, there are reports that smaller acetaminophen doses may overwhelm hepatitis sufferers.

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 acetaminophens hallmark sky-high liver enzymes.

Consider 23-year-old Marcus Trunk, who took prescription Tylenol with codeine for a wrist injury for 10 days and then over-the-counter acetaminophen for another week. Suddenly fever and vomiting struck.

"A hospital initially gave more acetaminophen before diagnosing liver failure," says his mother, Kate Trunk of Fort Myers, Fla. He died in a week an autopsy blamed acetaminophen.

Mrs. Trunk had thought that alcohol was acetaminophens only risk and said her son was a teetotaler.

Yesterday, her haunting thought: "If Id been more educated to acetaminophen products, could I have steered him clear?"


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