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Bmj Usa: Education And Debate

Commentary: The reintroduction of Lotronex for diarrhea-predominant irritable bowel syndrome

BMJ 2003; 327 doi: (Published 19 November 2003) Cite this as: BMJ 2003;327:E163
  1. Janet Woodcock, director (
  1. Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD

    From BMJ USA 2002;Nov:637

    The Food and Drug Administration approves program to provide patient access and manage risk

    Immediately after the November 28, 2000 announcement of the safety-related withdrawal of Lotronex, distraught patients, stunned that this therapy had been taken away from them, began to contact the Food and Drug Administration (FDA). Thousands of individuals from all walks of life—businesspeople, military personnel, government employees, teachers, health care workers—wrote or emailed the agency, demanding access to a drug they characterized as “giving them their lives back.” Meanwhile, the drug's manufacturer, Glaxo Wellcome, was shutting down production lines and ongoing clinical trials, having rejected the FDA's proposal to create a limited access program for severely affected people. Subsequently, under ongoing pressure from patients, the manufacturer opened discussions with the FDA on potential drug availability programs. Thus began the arduous process of crafting a proposal for the reintroduction of Lotronex.

    Lotronex had been withdrawn because outcomes from ischemic colitis (a known side effect) were more serious than predicted by the results of clinical trials and because of serious complications of constipation (a pharmacologic effect of a drug intended to reduce urgency and frequency). Cases of small bowel ischemia and a number of deaths had also been reported to the FDA. Irritable bowel syndrome (IBS) …

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