FDA Joint Panel to Probe NSAID Safety

January 29, 2014

A joint panel of FDA advisors will meet next month to discuss the cardiovascular (CV) thromboembolic risks of non-steroidal anti-inflammatory drugs (NSAIDs). The joint meeting of the agency’s Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee will is scheduled for Feb. 10-11 at the FDA’s White Oak, Md., campus.

A 2005 meeting of advisors concluded that both COX-2 selective NSAIDs and nonselective NSAIDs held potential risks but no decision was reached as to which held the greater threat.

The February meeting will discuss literature published since, with a specific focus on:

  • Whether the data show that naproxen has a lower CV thromboembolic risk compared to other nonselective NSAIDs and what this might mean for physicians;
  • Whether the published findings indicate a differential risk for non-naproxen NSAIDs;
  • Whether there is likely to be a latency period for increased risk for NSAIDs;
  • Whether there should be restrictions or specific warnings for higher-risk patients;
  • Whether NSAIDs should remain OTC in light of new findings; and
  • Whether the Precision trial should be altered in accordance with recent literature.

Some of the NSAIDs in question are Pfizer’s Bextra (valdecoxib) and Celebrex (celecoxib). — Lena Freund

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