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FDA reconsiders heart safety of common pain pills

WASHINGTON (AP) - Federal health experts are taking a second look this week at the heart safety of pain medications used by millions of Americans to treat arthritis and other everyday aches and pains.

The Food and Drug Administration holds a two-day meeting beginning Monday to examine the latest research on anti-inflammatory medicines called NSAIDS, which serve as the backbone of U.S. pain treatment.

The key question is whether naproxen - the key ingredient in Bayer's Aleve and many other generic pain pills - carries a lower risk of heart attack and stroke than rival medications like ibuprofen, sold as Advil by Pfizer and Motrin by Johnson & Johnson, among others.

Debate about whether one drug is safer than others in the class has waged for more than a decade without a clear answer, underscoring the lingering questions that hang over even the most established medicines.

The FDA is asking its panel of medical experts to review a massive analysis published last year suggesting that naproxen does not increase the risk of heart problems as much as its peers. The finding came from Oxford University researchers who reviewed results from more than 700 NSAID studies involving roughly 350,000 patients.

On Tuesday panelists will vote on whether naproxen has a lower risk of heart problems than other NSAIDs. Panelists will also discuss whether naproxen should be relabeled based on the latest safety data. The FDA is not required to follow the group's advice, though it often does.

If implemented, the labeling change could reshape the multibillion-dollar market for drugs used to treat muscle pain, arthritis and headaches. Last year U.S. consumers bought more than 275 million boxes of over-the-counter NSAIDs, representing $1.7 billion in sales, according to retail tracker IRI. Prescription NSAIDs brought in billions more, led by the Pfizer's blockbuster Celebrex, with sales of $2.9 billion.

But before any changes can be made, FDA advisers must consider reams of data that are often riddled with complicating factors:

- The Oxford analysis is difficult to interpret because it combines information from hundreds of unrelated studies. While this approach is useful in getting a broad view of rare events - such as heart attacks - it is not considered the strongest form of medical evidence.

- Almost all of the data under discussion come from studies of prescription NSAID pain relievers, which are taken at higher doses and for longer periods than over-the-counter NSAIDs. But panelists will be asked to make recommendations on the use of non-prescription drugs as well.

- Panelists will also be asked to make recommendations for narrow subgroups of patients, including those with a history of heart problems.

This week's FDA meeting is the latest chapter in an ongoing safety review that stretches back to 2004, when Merck & Co Inc. pulled its blockbuster pain reliever Vioxx off the market due to links to heart attack and stroke.

Vioxx had been heavily advertised as a new kind of NSAID that was supposed to be easier on the stomach. But its withdrawal shook the medical establishment and ushered in a new era of drug safety at the FDA.

In 2005, the agency added boxed warnings about the risk of heart attack and stroke to all prescription NSAIDS, including Celebrex and high-dose versions of ibuprofen and naproxen. Celebrex is the only drug from the same class as Vioxx that remains on the market.

The agency also beefed up labeling on lower-dose, over-the-counter NSAIDs like Aleve, Motrin and Advil. Those drugs currently warn patients to take the lowest dose possible for only a few days at a time to avoid the same risks as prescription NSAIDs.

But that advice is also getting a second look this week. A recent analysis by Danish researchers suggests heart problems can emerge with all NSAIDS after less than a week of treatment.

The FDA panel will also vote Tuesday on whether over-the-counter NSAID labeling should be changed to warn patients of the short-term risks.

Join the discussion

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Pat February 10 2014 at 7:20 PM

Never had any problems with Naproxin, but I only take in small doses and only when arthritis or muscle pain flares up. Now Plavix has burned holes in my stomach, but it is a blood thinner and it is prescription strength. Never occurred to me to take any pain pills (prescription or non) on a regular basis , but only if and when I was in pain. So far, that's worked well for me. Guess I'll keep it up.

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1 reply
carol lowery Pat February 10 2014 at 7:36 PM

Did you ever try fish oil instead of Plavix? It works as a blood thinner but I suppose it depends on what your condition is and what your doctor says. I had a blocked artery in my upper leg caused by a blood clot from another surgery so I had a bypass, the doctor said to take baby aspirin but I told him I was taking fish oil and he said that was ok in lieu of aspirin.

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Marrieah February 10 2014 at 9:01 PM

Damn, first they get rid of my VIOXX, now they want to get rid of my ALEVE? Not all meds work the same on everyone.

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allstarcaps February 10 2014 at 9:04 PM

All too often this is the case with Big Pharma, and their creations for profit. Marijuana has few side effects, is natural, and comes with great benefit to society. The ONLY reason Marijuana is illegal is because: 1. Big Pharma can not replicate and Patent it for profit. 2. The Wood and Lumber industry can not compete with Hemp paper products. 3. The Cotton Industry (most chemically dependent crop for success) can not compete with Hemp's hardy abundance and resistance to disease. 4. The Petroleum and Chemical Plastics Industry's would loose BILLIONS annually to Hemp's ability to produce durable goods not needing petroleum conversion to plastic. 5. Hemp clothing is far more durable, outlasting by dozens of washings, cotton and synthetic fibers - plus the fibers breath and are better diffusers of hot and cold. Last but not least Marijuana is a cheap, natural, effective pain reliever that can be grown in your own back yard!!

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wyndwalkr February 10 2014 at 9:15 PM

Watch out for Celebrex. I always had an "iron stomach", but Celebrex took care of that. In 2006 I had a perforated, abscessed pyloric ulcer. I just happened to be working in the ER on the Sun. night that it blew. Worst pain I have EVER had....felt like I had been shot with a flaming arrow that kept burning. Surgeon said it was so bad he might have to take part of my stomach: he didn't. He also said if I hadn't been in the ER at the time, I would never have made it to the hospital. I cannot believe they say you can take it without food....DON'T! Better yet, don't take it at all.

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Ken February 10 2014 at 9:23 PM

ALEVE put me in hospital for almost 1 week, and my doctor suggested I take it. The remainder of the product was distroyed. I will never take ALEVE again. I am a cancer patient and I really didn't need additional problems. No I didn"t sue, but the door is still open.

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TERRY February 10 2014 at 9:23 PM

I had bad shoulder pain during the "Tylenol kills your liver" scare, so I took Aleve for a few months. I was then going through major vertigo and resulting anxiety attacks, even messed up vision. I stopped taking the Aleve...NOW I'm on high blood pressure and anxiety meds...guess what the first side affect is? Dizziness. Sigh. I LOVE Tylenol!

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kjasperkc February 10 2014 at 9:28 PM

It appears that we are nothing more than lab rats. The FDA is worthless. I swear they are trying to kill everyone off.

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rottenboxes kjasperkc February 11 2014 at 1:01 AM

Stay away from any medications as much as possible. All meds have lethal side effects that manifest right away if overdosed or in time when taken for long periods of time.

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thefourthman07 February 10 2014 at 9:29 PM

Didn't the FDA approve this garbage for consumption to begin with?

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Fred Tinker February 10 2014 at 9:32 PM

This article is gobledyook. First it quotes a "2004" study that says the Naproxen may cause more heart attacks, and then it says Naproxen may be safer than other nsaids. Hello?

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1 reply
rethamh Fred Tinker February 10 2014 at 11:49 PM

That was my understanding also. Thought I had missed something.

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williamdee February 10 2014 at 9:52 PM

Never forget that the pharmaceutical industry has lobbyist stumbling all over each other in Washington buying influence for their medicines. So we must be our own best advocates as to what we are ingesting. Doctors are also courted heavily by the industry to push their particular brand of drug, so even our doctor's recommendations are slanted by the profit motive. Don't even get me started on all of the advertisements and their following list of all of the possible side effects.

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