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OTC FAQs: The Real-Life Realities Behind the FDA's New Recommendations

A Food and Drug Administration advisory panel voted yesterday to lower the recommended dose of over-the-counter acetaminophen, the controversial ingredient in popular painkillers like Tylenol and Excedrin. (It's a bit of news that may have been lost among the headlines about eliminating Vicodin and Percocet)According to the FDA, acetaminophen is the leading cause of liver damage in the U.S.

Concerned about the dangers of OTC painkillers containing acetaminophen, consumers might now opt for acetaminophen-free alternatives like ibuprofen and aspirin. But these substitutes can come with their own health hazards. NEWSWEEK's Johannah Cornblatt talked to Dr. Scott Fishman, chief of pain medicine at the University of California Davis School of Medicine and the president and chairman of the American Pain Foundation, about the real risks of acetaminophen, ibuprofen and aspirin. Excerpts:

Is acetaminophen the only bad guy? What are the health risks of over-the-counter alternatives to Tylenol, like ibuprofen and aspirin?
Any drug that potentially may be helpful has a risk of being harmful. All drugs have risks, including Tylenol and ibuprofen. It doesn’t mean that they can’t be used safely. Tylenol can be used safely, as can ibuprofen and aspirin. Aspirin is probably the riskiest of all. The risk of aspirin is that it can cause stomach ulcers, and it predisposes to bleeding. Aspirin causes a very long-lasting predisposition or effect. Ibuprofen does exactly the same thing but at a much shorter effect, so the risk is less. Both of those drugs can harm the kidneys, as well, impairing their ability to work. With Tylenol, the big risk is on the liver.

Are there any groups—people with a history of stomach trouble, for example, that shouldn't take ibuprofen and aspirin?
People who have had ulcers before who are sensitive to these medications or people who are at risk of bleeding, like people who are on other blood thinners. People who are taking natural supplements, like high doses of vitamin E, garlic, or fish oil really need to watch out. These are blood thinners, as well, so they’re additive.

Which product would you recommend that consumers take for acute or intermittent pain?
There’s no one product to recommend. Drugs like acetaminophen and ibuprofen are relatively safe in low dose for short-term use following the over-the-counter guidelines. If they’re not doing the job or they need to be used for long periods of time, you should consult a physician.

What counts as a long period of time?
A few days. These drugs can be tremendously effective. They can really be remarkably effective, and that’s why they’re widely used. They have a high rate of effectiveness relative to their risk when used wisely. If used in excess, they can be very risky. So that’s what the FDA is weighing now.

Which product would you recommend that consumers taken for chronic pain?
I wouldn’t make a recommendation of one product for chronic pain. Chronic pain requires a trained person to analyze what the pain is from and what the patients would do best with.

Is it OK to mix Tylenol with other over-the-counter options like Advil and aspirin?

Yes. But, again, it has to be done wisely. If you’re mixing these medications, you probably want to consult your physician.

If people are mixing products, how long should they wait between rotations?

Unclear and it depends on the individual. It depends on the individual and what is being treated. But they can effectively be rotated. It’s a strategy that we use a lot with children, as well as adults. It has a side effect sparing effect so that you’re not using too much of one or the other.

How much Tylenol would you have to take to damage your liver?

Nobody knows. Unfortunately, there have been cases where rarely it will happen at low doses. And we know people who have been on huge doses and had no liver damage. What we do know is that the higher the dose and the longer you’re on it, the greater the risk. That doesn’t mean that it couldn’t happen to anyone. But it very rarely happens if you’re only using the medication intermittently at recommended over-the-counter dosages

Should consumers still take Tylenol?
Oh yes. Take it in moderation. The consumers believe that because these are over-the-counter drugs, they’re safe in any amount. And that’s not true. These drugs can be substantially effective but can have serious side effects if taken in excess.

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