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FDA refuses companies' request to drop ulcer warning

BMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7283.385/c (Published 17 February 2001) Cite this as: BMJ 2001;322:385
  1. Scott Gottlieb
  1. New York

    Two competing manufacturers of the top selling prescription “superaspirins” in the United States, vying for a marketing edge, went before a panel of the US Food and Drug Administration (FDA) last week to ask the government to relax ulcer warnings on their labels but failed to win the expanded wording that they sought.

    Traditional non-steroidal anti-inflammatory drugs block both the related enzymes (cyclo-oxygenase-1 (COX 1) and cyclo-oxygenase-2 (COX 2)), which cause inflammation and pain. But COX 1 also protects the stomach lining. Researchers found that they …

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