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Another Painkiller Getting a Warning From the FDA

Dec 21, 2004 | AMERICAN MORNING CNN

BILL HEMMER, CNN ANCHOR: Yet again, another painkiller getting a warning from the FDA. What are the risks that you need to know from taking too much Aleve?

COSTELLO: The FDA has a warning out for the common over the counter pain reliever naproxen, sold under the brand name Aleve.

Joining us live from Washington with the risks and safety guidelines is Dr. David Graham, a drug safety researcher for the FDA.

Welcome.

DR. DAVID GRAHAM, FDA DRUG SAFETY RESEARCHER: Good morning.

Thank you.

COSTELLO: First of all, how concerned should we be about Aleve?

GRAHAM: I think, well, first, I'm speaking for myself and not the FDA. The commissioner speaks for the FDA. I think the American people need to be somewhat concerned about the safety of all of the pain relievers, but most especially the ones that still remain on the market that have come into the news -- Celebrex, Bextra and now Aleve and naproxen. Aleve is particularly disturbing because it's an over the counter drug. Over the counter drugs are supposed to be the ones that are the absolutely safest.

I think this asks the larger question, why has FDA not done the job it needs to do to protect America from unsafe drugs? The FDA needs...

COSTELLO: Well, can you try to answer that larger question? You're a drug safety researcher yourself.

GRAHAM: Right. I think there's a couple things. One, no one has held FDA accountable. FDA is still in denial that there's a problem with the way they go about evaluating and approving drugs. Until that changes, we will continue to get killer drugs approved and on the market.

We need to restructure the FDA so that safety has priority. There needs to be, I believe, a separate agency for product safety that would take care of drugs once they're on the market so that we don't have to wait for five years to discover that Vioxx or Celebrex cause heart attacks.

COSTELLO: Well, maybe the FDA is learning a little bit from Vioxx and Celebrex. I mean maybe it's just being cautious about this drug, Aleve, naproxen.

GRAHAM: Well, it's an expensive way to learn. I mean FDA is in the business, it's been in the business for many years of approving drugs. It says when it approves a drug, it's safe and effective. And yet we see with Vioxx that over 100,000 people had heart attacks. As many as 55,000 people died takeoff Vioxx, from heart attacks. That's nearly 20 times as many people as died on 9/11.

Senator Grassley has called for an independent commission similar to the 9/11 Commission to evaluate FDA's drug safety program and to come up with a solution for the United States. And I think I support that. I think that's what America needs now, because FDA is not protecting America from unsafe drugs.

COSTELLO: You're scaring me, actually. I mean what you're saying is really scary.

GRAHAM: Well...

COSTELLO: Is this a crisis?

GRAHAM: Well, I think it is a crisis that has come to light now. This is the this has been business as usual for the FDA for the 20 years that I've been there. The 20 years that I've been at FDA, safety has been at the back of the bus, if it's been on the bus at all. And now we are seeing what the result of that is when you get drugs that are used by tens of millions of Americans.

COSTELLO: And a final thought about Aleve, because so many people take this medication.

How dangerous is it?

GRAHAM: Well, the study that they reported that I read in the "New York Times" this morning says there is a 50 percent increase in heart attack risk. But this was a study that was done in a relatively small number of patients that were looked at for a long period of time.

The question is, is what's the risk with short-term use?

I suspect that if they found a 50 percent increase risk over long-term, that we're dealing with a 50 percent risk over the short- term, as well, and the only reason we haven't seen it in the study is the study wasn't big enough to identify the risk happening early on.

COSTELLO: Dr. David Graham, thanks for joining AMERICAN MORNING this morning.

GRAHAM: Thank you for having me.


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