Fw: FDA PROBES NEW ACETAMINOPHEN WORRY

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> FDA PROBES NEW ACETAMINOPHEN WORRY

>

> By n Neergaard Associated Press Monday, March 26, 2001

>

> http://wire.ap.org/

>

> WASHINGTON (AP) 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.

>

> 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 nonprescription, people think " it must be safe

> and they take it like M & Ms, " sighs Dr. 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, versus 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 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.

>

> 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.

> Honig, FDA's postmarketing drug safety chief.

> " We're 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. 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 acetaminophen's 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 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? "

>

>