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United States. Food and Drug Administration

FDA Panel Rules on Safety of Cox-2 Inhibitor Pain Drugs

Strategic Insights

— 1 min read

A US regulatory panel has ruled that pain drugs Celebrex and Bextra, made by Pfizer, and Vioxx, made by Merck, can remain on the market with strong warnings about increased heart and stroke risk. The decision was made by the Food and Drug Administration (FDA) advisory panel after a three-day hearing on the safety and potential restriction of Cox-2 inhibitors. The panel agreed that all three Cox-2 inhibitors significantly increase cardiovascular risk, prompting the need for a strong warning. Merck's shares surged 10% and Pfizer's rose 5% in New York trading after the announcement.

Key Takeaways:

  • The FDA advisory panel ruled that pain drugs Celebrex and Bextra by Pfizer, and Vioxx by Merck, can remain on the market with strong warnings about increased heart and stroke risk.
  • The panel concluded a three-day hearing on the safety and potential restriction of Cox-2 inhibitors, agreeing that all three Cox-2 inhibitors significantly increase cardiovascular risk.
  • The decision prompts the need for a strong warning, specifically a "black box" warning, for all Cox-2 inhibitors to inform consumers of the increased heart and stroke risk.
  • Merck voluntarily withdrew Vioxx in September after a company study found it doubled heart attack and stroke risks after 18 months.
  • Pfizer's Celebrex and Bextra also showed risks, although the company insisted its drugs were safe.
  • Merck's strategy of withdrawing Vioxx and then arguing that all Cox-2 inhibitors caused increased cardiovascular risks was rewarded by the regulatory panel.
  • The ruling could lead to Merck returning Vioxx to the market with regulatory restrictions.
  • The global sales of the drugs were approximately $6 billion last year.

Statistics:

  • 10% increase in Merck's shares
  • 5% increase in Pfizer's shares
  • $31.75 - Merck's stock price post-announcement
  • $26.36 - Pfizer's stock price post-announcement
  • 3 days - duration of the FDA advisory panel hearing
  • 18 months - timeframe when Vioxx was found to double heart attack and stroke risks

Sources:

  • "Pfizer's pain drugs can stay on market: U.S. panel" by Christopher Bowe, New York.

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