AILSA CHANG, HOST:
A prescription painkiller that has been under a cloud for more than a decade is apparently safer than previously believed. That is the conclusion of Food and Drug Administration advisers after they held a two-day hearing. NPR health correspondent Rob Stein joins us now with the details. Hey, Rob.
ROB STEIN, BYLINE: Hey, Ailsa.
CHANG: So all right, can you just start us off by talking about the drug at issue here? What is it?
STEIN: Yeah, so the drug is called celecoxib and most people might recognize the brand name, Celebrex.
STEIN: It's a painkiller that people take for arthritis and other kinds of problems. And but many doctors have been really reluctant to prescribe Celebrex and that's because it's really similar to another drug called Vioxx.
CHANG: Yeah, I remember Vioxx. It was pulled off the market - right? - because it was found to be dangerous.
STEIN: Yeah, yeah. So Vioxx was this blockbuster drug after it came out on the market in 1999 because it was supposed to be this whole new way to alleviate pain that was supposed to be a lot safer than other drugs. It didn't cause the stomach problems that other drugs caused. But it ended up being one of the biggest debacles in drug safety history in the United States because it was pulled from the market because they realized that it increased the risk for heart attacks and strokes.
CHANG: But Celebrex stayed on the market?
STEIN: Yeah, that's right. The FDA let Celebrex stay on the market with lots of warnings. And it ordered the company, Pfizer, that makes the drug to conduct a big study to try to get a really good fix on whether Celebrex is safe or not. So 24,000 people with arthritis took Celebrex or another painkiller like ibuprofen or naproxen to see which was safer and which was not. And then the FDA convened this special two-day hearing this week to review the results that study makes in recommendation to the FDA about Celebrex.
CHANG: So what did that study show?
STEIN: Yeah, so it was surprising. The study actually concluded that Celebrex was no riskier than these other really popular drugs like ibuprofen and naproxen and in fact, you know, that it didn't increase the risk any more. And the committee voted overwhelmingly that they agreed with the conclusions of the study. Now, it's important to point out that doesn't mean Celebrex is safe. All of these drugs do increase the risk for some complications, even heart problems.
Celebrex does, ibuprofen does, naproxen does. But the study showed that Celebrex was no riskier than these drugs and may actually be a little bit safer. So the committee says, you know, we should tell people about this. You know, they have this other option that might be an appropriate option for a lot of people.
CHANG: OK, so then what happens now?
STEIN: Yeah, so the FDA doesn't have to follow the advice of its advisory committees, but it usually does. So it has...
CHANG: Oh, (laughter) I didn't know that.
STEIN: No, it has the option of saying no. But this is pretty clearly a clear recommendation. And it's a big deal because millions of people rely on these drugs to alleviate pain from arthritis or twisted ankles or that sort of thing. And doctors these days are desperately looking for alternatives to opioids because we're in the middle of this horrible opioid epidemic of opioid addiction and overdoses. So the, you know, results of this could affect a lot of people.
CHANG: Did the committee say anything else about these drugs?
STEIN: Yes. So the other issue the committee looked at was whether it was safe for people to take lower doses of ibuprofen and naproxen, the kind you can buy over the counter, if you're already taking aspirin every day. And millions of people take aspirin every day to reduce the risk of having a heart attack...
CHANG: Sure, yeah.
STEIN: ...You know, or a second heart attack. But there's been some evidence that taking ibuprofen or naproxen could interfere with that protective effects of aspirin. And so they wanted to know what should we tell people with that? What should we say about it? And this was a little bit more mixed. They really weren't quite sure. But they decided in the end, yeah, we should warn people taking naproxen that this could be a problem.
And ibuprofen already has that kind of warning on the label.
CHANG: All right, that's NPR's Rob Stein. Thanks very much, Rob.
STEIN: Oh, sure. Thank you.
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