Scientists cite evidence many unwittingly take toxic doses of painkiller 

Associated Press

September 20, 2002

SILVER SPRING - Federal scientists urged stronger warning labels yesterday on every bottle of acetaminophen, based on evidence that thousands of Americans might unwittingly take toxic doses that could harm their livers. 

"You cannot allow more innocent men, women and children to suffer," Kate Trunk, whose 23-year-old " son Marcus died of an unintentional overdose, told a panel of Food and Drug Administration advisers. "Death is not an acceptable side effect." About l00 people a year are believed to die from unintentional overdoses. 

The FDA panel voted 21-1 to back her call for more warnings.

About 100 million people a year take acetaminophen, and serious liver damage is very rare, manufacturers insist. Although best known by the Tylenol brand, acetaminophen is in almost 200 different branded and generic products, from headache relievers to cold-and-cough remedies. It is also in a few prescription painkillers such as Percocet and Vicodin.

Instructions on acetaminophen bottles recommend taking no more than 4 grams a day, or eight extra-strength pills, and to seek help for overdoses. 

People often attempt suicide by swallowing handfuls of acetaminophen. That became such a problem in Britain that the country restricts how many tablets may be sold at once. 

Unintentional overdoses also can destroy the liver. Consumers often swallow a few extra pills in hopes of faster pain relief, falsely thinking that over-the-counter medications are safe enough to push the dose. Because acetaminophen is in so many products - often listed merely in the fine print - taking a few different remedies the same day can mean unknowingly ingesting potentially toxic amounts.

Some scientists warn that even taking the maximum safe dose for a long period, instead of the recommended day or two, might be risky.

The FDA asked its scientific advisers yesterday what steps it should take.

An FDA review found more than 56,000 emergency room visits a year because of acetaminophen overdoses, about a quarter of them unintentional. That is probably a severe underestimate of deaths
because many hospitals don't report unintentional poisonings, said University of Pennsylvania . pharmacist Sarah Erush.,

Acetaminophen is safe, but "people misuse these products," said Dr. Anthony Temple, vice president of McNeil Consumer & Specialty Pharmaceuticals, Tylenol's maker. McNeil is about to place new warnings on its acetaminophen products to say that "an overdose may cause liver damage."

FDA's advisers praised McNeirs new labels as a good first step but urged more changes for all acetaminophen makers - namely, that every bottle should say it contains acetaminophen in large bold type in the front.

This isn't the first time acetaminophen has drawn federal concern.

In 1977, the FDA's advisers recommended more explicit warnings against exceeding the dose or taking acetaminophen for more than 10 days "because severe liver damage may occur." The FDA never
followed that advice but pledged to quickly consider its advisers' latest recommendation.

Copyright  2002, The Baltimore Sun