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

doi:10.1136/bmjusa.02110002

BMJ, doi: 10.1136/bmjusa.02110002, (Published 20 February 2003)

Education and debate

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

Janet Woodcock, director.

Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD (
woodcockj@cder.fda.gov)
The first 150 words of the full text of this article appear below.

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, stunnedthat this therapy had been taken away from them, began to contactthe Food and Drug Administration (FDA). Thousands of individualsfrom all walks of life $---$ businesspeople, military personnel, governmentemployees, teachers, health care workers $---$ wrote or emailed theagency, demanding access to a drug they characterized as "givingthem their lives back." Meanwhile, the drug's manufacturer, GlaxoWellcome, was shutting down production lines and ongoing clinicaltrials, having rejected the FDA's proposal to create a limitedaccess program for severely affected people. Subsequently, underongoing pressure from patients, the manufacturer opened discussionswith the FDA on potential drug availability programs. Thus beganthe arduous process of crafting a proposal for the reintroductionofLotronex.

Lotronex had been . . . [Full text of this article]

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