FDA warns Merck over its promotion of rofecoxib

BMJ 2001; 323 doi: (Published 06 October 2001) Cite this as: BMJ 2001;323:767
  1. Deborah Josefson
  1. San Francisco

    The US Food and Drug Administration has issued a warning letter to the pharmaceutical company Merck for misrepresenting the safety of their blockbuster anti-inflammatory drug, rofecoxib (Vioxx).

    Rofecoxib, a selective cyclo-oxygenase-2 (COX 2) inhibitor, was approved by the administration in May 1999 for the relief of acute pain, osteoarthritis, and dysmenorrhoea. The drug was heavily promoted by Merck and touted as safer than and superior to non-selective, non-steroidal anti-inflammatory drugs such as ibuprofen and naproxen.

    In its …

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