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Continued: Safer for the heart? FDA weighs pain meds

  • Article by: MATTHEW PERRONE , Associated Press
  • Last update: February 10, 2014 - 11:51 PM

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

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  • The FDA is looking at whether naproxen, the key ingredient in Bayer’s Aleve, carries a lower risk of heart attack and stroke.

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