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Tylenol Overdoses Linked To Acute Failure of Liver

By DENISE GRADY

The New York Times, October 16, 1997

Overdoses of Tylenol or other medications containing its active ingredient, acetaminophen, were the leading cause of hospitalization for acute liver failure at a large medical center in Dallas from 1992 to 1995, researchers are reporting in the first study in the United States to measure the incidence of the problem. Although uncommon, the condition is serious and potentially fatal.

The researchers also found that heavy drinkers who took too much acetaminophen were especially vulnerable to liver damage, an effect observed by other scientists as well. Tylenol is the most popular painkiller in this country. Americans take eight billion to nine billion tablets of the drug a year, according to its manufacturer, the McNeil Consumer Products Company, a subsidiary of Johnson & Johnson. More than 200 other products also contain acetaminophen.

The new research does not mean that people should stop using acetaminophen, said the director of the study, which is to be published today in The New England Journal ol Medicine. But it does mean that more education is needed to alert both patients and doctors not to exceed the recommended doses, said the researcher, Dr. William Lee.

Dr. Lee, director of the clinical center for Liver diseases at the University ol Texas Southwestern Medical Center in Dallas, also said in a telephone interview that people should consider taking doses even smaller than those recommended

Current packaging instructs users to take no more than four grams ol acetaminophen, or eight extra strength tablets, in 24 hours, and to consult a doctor before taking the drug at all if they regularly consume three or more alcoholic drinks a day.

But Dr. Lee said that people who drink and even those who do not, should consider limiting acetaminophen to two grams a day instead ol the four grams now recommended. "Maybe that's a little cautious," he said, "but it's safer."

Although people may assume that over-the-counter drugs are harmless, acetaminophen Is not, Dr. Lee said. Compared with other medications, he said it becomes toxic at doses relatively close to the doses used in treatment.

"The window between therapy and toxicity is much smaller with acetaminophen than with most other compounds," Dr. Lee said.

Dr. Hyman Zimmerman, a researcher at the Armed Forces Institute of Pathology in Washington, who did not participate in the study, said he agreed with the two-gram recommendation. Dr. Zimmerman also called the present alcohol warning inadequate.

"If you drink," Dr. Zimmerman said, "you're not going to call your doctor at 2 in the morning and say ' I've got a headache. Can I take acetaminophen?'"

Dr. Zimmerman said the warning should tell all patients, including those who have three drinks a day, not to take more than two grams of acetaminophen a day.

But Dr. Anthony Temple, executive director of medical affairs at McNeil, said: "I think both Dr. Lee and Dr. Zimmerman are way too cautious and conservative."

Cases of liver damage from acetaminophen were rare, Dr. Temple said, and data show that millions of people, including alcoholics, have followed the four-gram guidelines without ill effects. He also said there were no scientific data to support changing the dosage levels that had been approved by the Food and Drug Administration.

Dr. Lee and his colleagues conducted their study at Parkland Memorial Hospital in Dallas by reviewing the records ol patients who were treated lor acetaminophen overdose from 1992 to 1995. There were 71 cases, including those ol 50 people who had attempted suicide, taking 3 grams to 125 grams ol the drug, and 21 people who had taken accidental overdoses, taking 2 grams to 30 grams, to relieve pains like toothaches, headaches and stomach aches. Five patients died and 66 recovered, after hospital stays from 1 to 51 days.

All the patients sustained liver damage, but 10 developed a serious condition known as acute liver failure, indicating extensive injury to the organ. They accounted for all 5 deaths in the study, and 40 percent of the cases of acute liver failure treated at Parkland in the study period, making acetaminophen the leading single cause of acute liver failure at the hospital in that time.

Those with accidental overdoses accounted for 7 of the 10 with acute liver failure and 4 died compared with only 1 death in the attempted suicide group. Their overdoses came about becaues they took too many pills at once or repeated doses too often in an effort to relieve pain.