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Yet Another Pain Reliever Under Close Scrutiny Today


BILL HEMMER, CNN ANCHOR: Yet another pain reliever under close scrutiny today, this one over the counter. What are the dangers? What do you need to know?

Now to a new warning about the pain reliever Naproxene, also known as Aleve. Researchers found a link between the drug and increased risk of heart attacks and stroke. The Food and Drug Administration is cautioning users readers to read instructions carefully and avoid using the drug longer than the recommended 10 days. Bill has much more on this coming up.

EMMER: The FDA now warning patients about the risks in the popular over-the-counter painkiller Naproxen, sold under the brand name Aleve. Government researchers ended a study that revealed a dramatic increase in heart attacks and strokes.

Dr. John Abramson is a medical school professor from Harvard, the author of "Overdosed America." He's also my guest this morning in Watertown, Massachusetts.

Doctor, good to have you, and good morning to you.

DR. JOHN ABRAMSON, AUTHOR, "OVERDOSED AMERICA": Good morning, Bill. How are you?

HEMMER: I'm doing fine.

Different day, different drug, what's going on out there? Can you make sense of it for us?

ABRAMSON: Well, I think I can. I think what we've got is like three dominoes that are falling down. The first domino that fell was at the end of September when Vioxx was found to cause significantly more heart attacks and strokes than placebos, in a study designed to see if Vioxx would suppress colon polyps. Now Vioxx there was a track record of cardiovascular risk and doubt about Vioxx. So that made sense when we saw that result.

The next was domino that fell was Celebrex, when we saw that Celebrex in one study increased the risk of heart attacks and strokes. Now that made sense in a way, because it's a Cox-2 inhibitor, and it may increase the clotting tendency of the blood, but we hadn't seen those studies before showing the cardiovascular risk in Celebrex.

The final domino that fell was Naproxen. The study was really opened, stopped because of concerns about Celebrex. And when the study was stopped, it was found that Naproxen was causing more heart attacks and strokes than placebo.

Now there is no theoretical basis for this. And it may well be, this is like flipping a coin 10 times and having it come up heads six or seven times, just being a random event.

HEMMER: So it comes in threes apparently, too, with the drug companies, specifically for Naproxen, if you're taking it, and if they say you should not exceed the recommended dosage, should you be taking this at all until you get more information?

ABRAMSON: Bill, it's unlikely that history is going to show us this is a serious problem. I think, for the time being, we ought to have caution. The nonprescription dose of Naproxen or Aleve is one tablet twice a day, and the cautious approach right now is to take no more than that, and to take it for no more than 10 days duration.

HEMMER: We were speaking in our morning meeting today whether or not people take the recommended dosage they need or whether or not they just feel they take the amount they need at a time. Through your studies, what do you find about the consumer side of that?

ABRAMSON: Well, I think most of the consumer side, Bill, is driven by the advertisements. We've seen so many advertisements for Vioxx and Celebrex. It's important to remember that there really is an issue here, that doctors and patients were presented with a misleading picture of Celebrex and Vioxx. Neither drug provides better relief for arthritis pain. Neither drug is safer than the alternatives.

The real core problem here is that the full information the drug companies knew and the FDA knew wasn't shared with customers. Now, I think it's spilling over into a generalized concern about all drugs. I think we need to go back to the real problem, which is making sure that doctors and patients have the best possible information about our prescription drugs.

HEMMER: Yes, but what you're saying, that could be quite alarming what you're saying there, if you don't have the full amount of information.

ABRAMSON: Absolutely. Absolutely. And the really most alarming part of it, is even our best medical journals, "The New England Journal of Medicine" and "The Journal of the American Medical Association," where the scientific data was presented, key elements of the scientific data were left out. So even the most dedicated doctors couldn't know the truth about these drugs. That's the real problem we need to fix, Bill. As this crisis is now open, it's like the patient is on the operating table, and this is the problem we need to fix.

HEMMER: You've given us a lot to think about. Thank you, doctor. John Abramson there, our guest in Watertown, Massachusetts. Thanks for your time today.

ABRAMSON: Pleasure to be with you, Bill.

HEMMER: Also, next hour here on AMERICAN MORNING, we'll talk with the FDA drug safety researchers, Dr. David Graham, our guest there next hour.

HEMMER: All right, welcome back, everybody. Naproxen warning, yet another bad dose of news for investors and advertisers. Andy checks in new, first check of "Minding Your Business" on this Tuesday morning. Good morning to you.

ANDY SERWER, "FORTUNE" MAGAZINE: Good morning to you, Bill.

Wall Street is all abuzz over the implications of these drug companies' woes. And obviously, this is very big news, not only for patients and doctors, but for investors as well. You know, drug stocks used to be some of the safest investments that you could make. They were steady. They grew. You had the demographics at your back, in terms of the aging population. But now, a lot of people on Wall Street are calling all that into question. And drug stocks have been terrible performers for the year.

In fact, the two biggies in the news lately, Merck and Pfizer, down 32 percent year-to-date. You can see here's Pfizer fizzling. And Merck, they used to call it Sir Merck, in the same boat. Bayer, by the way, is the company that makes Aleve. That's a German company, the same company that makes Aspirin. Their shares are down in early trading.

And of course there's collateral as well, because drug companies have been huge advertisers on television. You've seen them on this network, their ads, as well as magazines. For instance, Pfizer was going to be spending $82 million in advertising this year. And you know, that's called into question. And these companies overall spend billions and billions of dollars. The whole notion of blockbusters, Bill, blockbuster drugs, a lot of people are wondering, you know, is that business model going to hold steady going forward, so still a lot to sort out from a Wall Street perspective.

HEMMER: You talk about the collateral damage, too, and mention the Dow, too. The drag has been on that as well.

SERWER: That's right, because Merck and Pfizer are both Dow stocks.

HEMMER: Exactly. Thank you, Andy.

SERWER: You're welcome.

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