Article: FDA: Misusing Acetaminophen Can Be Deadly

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FDA: Misusing Acetaminophen Can Be Deadly

 

January 22, 2004 08:13 PM EST

 

 

 

 

WASHINGTON - Too many Americans unwittingly overdose on over-the-counter

painkillers, or take the wrong ones. Now the government is warning

consumers that following the directions can mean the difference between

feeling better or suffering severe, even lethal, side effects.

 

Topping the warning list is the popular painkiller acetaminophen, best

known by the Tylenol brand but present in more than 600 products that

treat pain, coughs, cold and flu. Taking too much can poison the liver.

 

More than 56,000 emergency room visits a year are due to acetaminophen

overdoses, and about 100 people a year die after an unintentional

overdose of the drug, according to Food and Drug Administration

estimates.

 

Sometimes consumers swallow extra pills in hopes of faster pain relief.

Others unknowingly ingest too much by taking more than one

acetaminophen-containing remedy.

 

Most acetaminophen products are nonprescription, but there are some

prescription ones, such as Vicodin. Often the ingredient is listed only

in the label's fine print or, for prescription drugs, with the confusing

abbreviation APAP.

 

In drugstore brochures and public service ads unveiled Thursday, the FDA

will urge consumers to check which products contain acetaminophen and

carefully follow dosage instructions.

 

It's not the only over-the-counter drug getting attention: FDA's

campaign also will warn that certain patients are at increased risk of

other side effects from different painkillers - such as aspirin,

ibuprofen, naproxen or ketoprofen - called NSAIDs, or nonsteroidal

anti-inflammatory drugs. Those side effects include stomach bleeding and

kidney problems.

 

" We want them to take these medications seriously and understand the

consequences if they don't follow directions, " said Ellen Shapiro, who

heads FDA's consumer outreach.

 

But the FDA's new campaign falls short of the recommendations of its own

scientific advisers, who in 2002 urged that warning labels be placed

directly on the labels of over-the-counter painkillers to ensure their

users know these risks.

 

Nor is it a large campaign. Armed with just $20,000 to develop the

materials, the FDA is depending on pharmacy chains to put the brochure

in stores and hopes major magazines will run the ads for free. The

agency says it couldn't afford to even develop a public service

announcement for television.

 

" I'm a little angry " at the small effort, said Kate Trunk of Fort Myers,

Fla., who has urged the FDA for three years to increase acetaminophen

warnings after her son died from an unintentional overdose after a wrist

injury.

 

" The responsibility should be, at least in some part, put on

manufacturers to inform consumers also, " Trunk said.

 

The FDA says work on warning labels is still under way, with a decision

expected later this year.

 

" Educating people about the risks of not using these products correctly

is more important, " said Dr. Charles Ganley, FDA's nonprescription drugs

chief.

 

He points to efforts a few decades ago that successfully taught parents

to never give children or teenagers aspirin during a viral illness

because of the risk of deadly Reye's syndrome, something drug warning

labels alone couldn't accomplish.

 

In addition to dosage warnings, FDA's new campaign says:

 

-The risk of liver damage increases if you have three or more alcoholic

drinks while using acetaminophen.

 

-It's rare for stomach bleeding to occur with NSAIDs using

over-the-counter doses for short periods of time. Risk increases,

however, for people who are over 60; take prescription blood thinners or

steroids; have a history of stomach bleeding or other bleeding

disorders; or have three or more alcoholic drinks a day.

 

-NSAIDs also can cause some reversible kidney problems; people most at

risk are those who are over 60, have pre-existing kidney disease or take

blood pressure medicine known as diuretics.

 

Some 100 million people a year take acetaminophen, and serious liver

damage is very rare, manufacturers insist. Still, McNeil Consumer &

Specialty Pharmaceuticals, the manufacturer of Tylenol, voluntarily

upgraded warnings on its acetaminophen-containing products to explain

the liver risk - and has begun listing the ingredient's name in large

type on the box front of multi-ingredient products like Tylenol Cold.

 

" People need to know what's in their medicines and then use them

properly, " said company vice president Dr. Anthony Temple, who wants the

FDA to make other manufacturers follow suit. " If they dose properly and

use it properly, these are safe and effective medicines. "

 

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On the Net:

 

Food and Drug Administration: http://www.fda.gov/

 

 

 

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Copyright 2003 Associated Press. All rights reserved.