In March last year the Lancet published a randomized trial detailing the efficacy and safety of alosetron for women with irritable bowel syndrome.
The FDA had licensed the drug in February 2000. By November last year, GlaxoWellcome had voluntarily withdrawn alosetron from the market, because five people had died after taking the drug.
|Alosetron was withdrawn from the US market in November 2000.
The Commentary, by Lancet Editor Richard Horton, states that many senior officials within the FDA are seeking to reintroduce alosetron. An advisory committee meeting to do so is being planned for June or July.
Horton comments, "This story reveals not only dangerous failings in a single drug's approval and review process, but also the extent to which the FDA, and its Center for Drug Evaluation and Research in particular, has become the servant of industry".