FDA reconsiders heart safety of common pain pills

Published on NewsOK Modified: February 10, 2014 at 3:37 pm •  Published: February 10, 2014

Monday's meeting mainly consisted of presentations dissecting the latest findings from academics, FDA scientists and drug company staffers.

The pharmaceutical companies generally staked out positions that would most benefit their respective products.

Bayer, which markets Aleve, said the drug's labeling should reflect the new research suggesting it is a safer option.

Pfizer, maker of Advil and Celebrex, argued that there is no conclusive data that naproxen is safer than other products. The New York company said current labeling should remain in place until more conclusive evidence is available.

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.

But the FDA is considering halting work on that study given that evidence already suggests lower rates of heart attack and stroke for naproxen. FDA's panel will weigh in on the fate of the study Tuesday.

This week's meeting is the latest chapter in an ongoing safety review of NSAIDS 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 vote Tuesday on whether over-the-counter NSAID labeling should be changed to warn patients of the short-term risks.

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