FDA Advisers Urge Smaller Doses of Acetaminophen

U.S. health advisers recommended Tuesday to lower the maximum dose of over-the-counter acetaminophen—the key ingredient in Tylenol, Excedrin and many other pain-killing medications.

The advisers’ vote followed the release of a U.S. Food and Drug Administration report last month. It found that severe liver damage and even death can result from a lack of consumer awareness that acetaminophen—which is easier on the stomach than painkillers such as aspirin and ibuprofen—can cause such injury.

Also, many people may take more than the recommended dose of acetaminophen-based, over-the-counter pain relievers in the mistaken belief that taking more will be more effective against pain without posing health risks. And consumers may not know that acetaminophen is present in many over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose, the report said.

The FDA advisory panel voted 21-16 Tuesday to lower the maximum daily dose of nonprescription acetaminophen, which is currently 4 grams - equal to eight pills of a drug such as Extra Strength Tylenol. The panel was not asked to recommend another maximum daily dose.

The panel also voted 24-13 to limit the maximum single dose of acetaminophen to 650 milligrams. The current single dose of Extra Strength Tylenol, for instance, is 1,000 milligrams.

The panel also voted 26-11 to make the 1,000-milligram dose of acetaminophen available only by prescription.

The advisers voted against other safety restrictions for other over-the-counter drugs such as NyQuil or Theraflu, which contain acetaminophen and other ingredients that treat cough and runny nose. Patients often mix the cold medications with pure acetaminophen drugs, like Tylenol, leaving them vulnerable to dangerously high levels of acetaminophen.

The FDA is not obligated to follow the recommendations of its advisory panels, but it typically does so.

Despite more than five years of FDA-sponsored consumer education campaigns, “recent studies indicate that unintentional and intentional overdoses leading to severe hepatotoxicity [liver damage] continue to occur,” last month’s report said.

Dr. John H. Klippel, chief executive officer of the Arthritis Foundation, said Tuesday’s votes were very important to “people with arthritis because acetaminophen is a very commonly used medication to control pain.”

“Lowering the maximum dose, providing that kind of guidance to patients, if it increases safety, would be something the arthritis community would support,” he said. “Every person who takes this drug sees it as valuable, but they want clear guidance so they won’t be harmed by the drug.”

Dr. Lewis W. Teperman, director of transplant surgery and vice chairman of surgery at New York University, said he supported the panel’s decision to recommend lowering doses of acetaminophen.

“It’s not that the doses can get you in trouble, but the very young and the very old can get into trouble easily,” he said. Also if you are sick there is the danger of taking cold remedies that contain acetaminophen plus taking pure acetaminophen drugs as well, he noted.

But Klipper said the vote to make the 1,000-milligram dose of acetaminophen available only by prescription would overburden the health-care system. “Given the massive number of people who rely on this drug for pain control, making the maximum dose requiring a prescription, I think is going to place undo burden on the health-care system,” he said.

On the other hand, Teperman supported the 1,000-milligram recommendation.

“The 1,000 milligram pill should never be at the patient’s discretion. It should only be prescribed by a physician,” Teperman said. “If you took an entire bottle of Tylenol Extra Strength, three days later you would be in a coma and needing a liver transplant.”

Klippel said he’d like to see more education for consumers, alerting them to the potential dangers of acetaminophen. “Give consumers the benefit of the doubt,” he said. “Consumers want to do the right thing, and if dosage in acetaminophen is important the consumer will follow.”

By Steve Reinberg
HealthDay Reporter