TOPICS > Health

FDA Panel Recommends Ban on Popular Painkillers

July 1, 2009 at 6:45 PM EDT
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A doctor assesses a new FDA panel recommendation for a ban on such popular painkillers as Vicodin, Percocet and other drugs containing acetaminophen.


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.

A ban on Percocet and Vicodin

RAY SUAREZ: Also included in the FDA recommendations, an attempt to ban Percocet and Vicodin. Why?

DR. SCOTT FISHMAN: Well, Percocet and Vicodin-type drugs are co-compounded drugs, meaning that they're drugs that package together two different drugs into one pill for the convenience of having them together, with the thinking being that the average person only needs a little bit of one and a little bit of the other.

The problem is that, when these compounds, which usually have, say, hydrocodone and acetaminophen, in a drug like Vicodin, when someone needs more of the hydrocodone, they are forced to take more of the Tylenol or the acetaminophen component, therefore pushing the patient into an optimal level of one and a toxic level of the other. That's the problem. I don't -- yes, go ahead.

RAY SUAREZ: I'm sorry. Go ahead, finish.

DR. SCOTT FISHMAN: Yes, I don't think the FDA is telling the public we need to get rid of these drugs. They're telling the public that we need to stop co-compounding them together, because while that is convenient, it's not necessarily safe.

RAY SUAREZ: Well, Vicodin is one of the most heavily prescribed drugs in the United States. If you split it apart from its acetaminophen component, will it be as useful? Will it be as widely effective as it's considered now?

DR. SCOTT FISHMAN: Well, you asked two questions there. It would certainly be as effective, because there's nothing limiting you from using hydrocodone and acetaminophen separately but at the same time, and they would be effective together. And each together allows you to use a little bit less of each one and spares you of risk.

But the problem with Vicodin is that there's no specific hydrocodone product that's compounded on the market today. So this will leave some patients without a hydrocodone product to use, but there are many other opioid-type medications that can be prescribed in its place that are equally effective.

And, again, I would stress that you can take the acetaminophen and the hydrocodone or oxycodone, which is found in Percocet, alone, in isolation, and then add the acetaminophen. So if the oxycodone or the hydrocodone needs to go up, the acetaminophen can still stay at safe levels.

RAY SUAREZ: So if you're sitting at home and watching television, if you're one of the tens of millions with acetaminophen product in their medicine chest, should you do anything differently from what you've been doing thus far?

DR. SCOTT FISHMAN: Well, I would suggest speaking to the prescribing physician and asking, "Am I taking too much acetaminophen with the dose that I'm taking right now of my hydrocodone or oxycodone in the Vicodin or Percocet?"

If the answer is yes, you should stop and switch to a product that gives you each drug individually and modulate them individually. If not, if you're not taking too much acetaminophen, I don't think there's anything wrong with that.

I think what the FDA is trying to say is that, in the future, we should be making these products in isolation so patients don't have to make these choices.

RAY SUAREZ: Dr. Fishman, thanks for joining us.

DR. SCOTT FISHMAN: A pleasure.