Federal health experts have taken a second look at the heart safety of pain medications used by millions of Americans to treat arthritis and other everyday aches and pains. The re-examination is based on the latest research on anti-inflammatory medicines called NSAIDS, which serve as the backbone of U.S. pain treatment. The answer being sought is whether naproxen (which is the key active ingredient in Bayer’s Aleve and 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).
The FDA is asked its panel of medical experts to review a massive analysis published last year by Oxford University suggesting that naproxen does not increase the risk of heart problems as much as rival medications. This study monitored about 35000 patients being treated with prescription or over the counter NSAIDs. The labeling change could reshape the multibillion-dollar market for drugs used to treat muscle pain, arthritis and headaches.
For 2013, U.S. consumers bought more than 275 million boxes of over-the-counter ibuprofen and naproxen, representing about $1.7 billion in sales. Then if you add prescription NSAIDs which brought in billions more, led by the Pfizer’s Celebrex, with sales of $2.9 billion and you can see why this is so important. It is also important to factor in what can happen if a decision is rushed. Vioxx (Merck) had been heavily advertised as a new kind of NSAID that was supposed to be easier on the stomach. But after additional studies and product complaints, the FDA added black box warnings about the risk of heart attack and stroke to all prescription NSAIDS, including Celebrex and high-dose versions of ibuprofen and naproxen. Merck eventually pulled the product from the market and is currently settling lawsuits.
The task at hand is going over the 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. This approach is useful in getting a broad view of rare events such as heart attacks but it is not considered the strongest form of medical evidence. Pfizer is wrapping up work on a large multiyear study called PRECISION designed to definitely answer whether there is a difference in cardiovascular safety between naproxen, ibuprofen and Celebrex. As you know, billions of dollars are at stake for all the parties involved.
The end result was inconclusive. After going over all the data, the claim was there was not enough scientific evidence to support that Naproxen was better than other medications at preventing cardiac events. This will be temporary until another study is performed that can prove one class of pain relievers is better than the other. For now, everyone should use in moderation, the pain reliever they like most for their minor aches and pains.
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