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FDA: Misusing over-the-counter painkillers can have lethal results

By Associated Press
Published January 23, 2004

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 ingest too much by taking more than one acetaminophen-containing remedy.

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.

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.

FDA moves against firm importing Canadian drugs

WASHINGTON - The federal government moved on Thursday to shut down another company accused of importing cheaper Canadian drugs to the United States. The Texas company argued it is essentially a records processor doing nothing wrong.

The Food and Drug Administration gave Temple-based Expedite-Rx 15 days to explain how it would begin complying with laws outlawing the importation of foreign drugs, or face legal action. This is the third time the agency has targeted companies involved in Canadian imports.

Expedite-Rx is part of a program that allows employees and retirees of Montgomery, Ala., to buy Canadian drugs. Montgomery is one of two U.S. cities so far that have such programs, although numerous states are considering them.

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