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Pharmaceutical industry

FDA Panelists Weigh Risks and Benefits of COX-2 Inhibitors

Strategic Insights

— 1 min read

FDA advisory panelists converged on the risks and benefits of COX-2 inhibitors, a class of pain medications that includes Celebrex, Bextra, and Vioxx. The panelists raised concerns about the increased risk of heart attacks and strokes associated with these drugs, but ultimately voted to keep them on the market, albeit with strong warnings about their cardiovascular risks.

Key Takeaways:

  • COX-2 inhibitors, such as Celebrex and Bextra, increase the risk of heart attacks and strokes, although the exact magnitude of this risk is still unclear.
  • Patients at risk for stomach bleeding and heart attacks may take older pain relievers, such as aspirin and ibuprofen, with stomach-protecting medications like Prevacid or Nexium before considering COX-2 inhibitors.
  • Merck, the manufacturer of Vioxx, may reintroduce the drug to the market, citing new information about the risks of other arthritis drugs.
  • Older pain relievers, such as naproxen, may have some protective effects on the heart, although little is known about their long-term cardiovascular effects.
  • Some panel members expressed concerns that removing COX-2 inhibitors from the market could lead to a shift towards safer drugs, but others argued that labeling and warning measures, such as black-box warnings, may not have a significant impact on prescribing practices.
  • The FDA typically follows its panels' advice, but the close votes on Bextra and Vioxx present challenges for the agency, which plans to make a decision within the next several weeks.

Statistics:

  • The FDA advisory panel voted unanimously that COX-2 inhibitors significantly increase the risk of heart attacks and strokes.
  • A majority of panel members supported keeping Celebrex and Bextra on the market, although the vote on Vioxx was close.
  • UNDATED - A survey found that Celebrex and Vioxx are top sellers in Australia, where direct-to-consumer advertising is prohibited.

Sources:

  • Garret FitzGerald, University of Pennsylvania pharmacologist
  • Peter Kim, Merck executive
  • Tracy Ogden, Merck spokesperson
  • Anne Trontell, FDA
  • Louis Morris, psychologist and panel member
  • David Graham, FDA scientist
  • Alastair Wood, Vanderbilt University pharmacologist
  • Henry Krum, cardiologist and pharmacologist

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