FDA Panel Recommends Ban on Popular Painkillers

RAY SUAREZ:

Acetaminophen — most commonly known as Tylenol — is one of the most frequently used pain relievers in the U.S. It's generally considered safe and, for many people, offers some advantages over aspirin and ibuprofen.

But when used at certain dosages or in combination with other medicines – it can raise the risk of liver damage and, in a small number of cases, lead to death.

Yesterday, an expert panel met to deal with those issues and made a series of recommendations to the Food and Drug Administration, including: reducing the highest single dose of acetaminophen sold over the counter to 325 milligrams; lowering the maximum daily dose that can be used safely to less than 4,000 milligrams; and a ban on the prescription painkillers Percocet and Vicodin.

To help us understand the latest, we're joined by Dr. Scott Fishman, the president of the American Pain Foundation. He's a professor of anesthesiology at the University of California Davis School of Medicine.

Dr. Fishman, it's a near-ubiquitous drug, and ten thousand — well, thousands of Americans are hospitalized every year with acetaminophen overdose, and hundreds die. Is it easy to overdose on over-the-counter medicine?

DR. SCOTT FISHMAN, University of California-Davis School of Medicine: Well, I think the public feels that these over-the-counter medicines are safe because they wouldn't be over the counter otherwise. And, therefore, some folks assume that, if they're that safe, they can take more than is recommend. Unfortunately, these medications can be extremely effective, but they can be risky when taken outside or in excess of recommended dosages.

RAY SUAREZ:

How does acetaminophen cause liver damage?

DR. SCOTT FISHMAN:

Well, it's complex biochemistry, but it interacts with the liver and undermines the liver's ability to clear out toxins. It damages the cells and the machinery within the liver that provides a vital function to health, usually in higher doses. One of the concerns that we have is not just with higher dose, but is with continuous dose or chronic exposure to the body, as well.

RAY SUAREZ:

If you're a healthy person and you follow the guidelines on the side of the jar of pills, are you in danger from taking acetaminophen?

DR. SCOTT FISHMAN:

Well, there's risk with every medicine that we take. Any medicine that can provide benefit has risk of doing harm. The question is, how much risk relative to the risk of not treating oneself?

The risk of taking low doses of acetaminophen or even ibuprofen or drugs like that are very low when they're taken for short periods of time in small dosages or the recommended dosages over the counter. At dosages higher than that or for longer period of times than a day or two, one should consult a physician.

RAY SUAREZ:

Well, the FDA recommendations are certainly leaning toward trying to get people to take less acetaminophen in the course of a day. Is that enough to get rid of a headache, if that's what you're taking it for?

DR. SCOTT FISHMAN:

It probably is. These medications are very effective, including acetaminophen, which is found in drugs like Tylenol, as well as ibuprofen-type medicines, as well. We probably don't need as much as many of us think we need; more isn't necessarily better.