Alosetron for irritable bowel syndrome

doi:10.1136/bmj.326.7379.51/b

BMJ 2003;326:51 ( 4 January )

Letters

Alosetron for irritable bowel syndrome

Senior vice president of GlaxoSmithKline responds

Risks of using alosetron are still unknown

Senior vice president of GlaxoSmithKline responds

The first 150 words of the full text of this article appear below.

EDITOR $---$ As the senior doctor at GlaxoWellcome and GlaxoSmithKline who participated in all of the key meetings that resultedin the withdrawal of Lotronex (alosetron) and the subsequent approvalfor reintroduction, I feel compelled to reply to both the articleand editorial on alosetron. ¹ ²

Moynihan sees a complex web of intrigue where none existed, at least from the viewpoint of GlaxoWellcome and GlaxoSmithKline.¹Here are the key elements of the story from ourposition.

We had a medical disagreement with the Food and Drug Administration about the aetiology of the serious adverse events occurringin patients taking alosetron. In November 2000 we had severalmeetings with the administration, which led to a meeting on 28November where we realised we could not come to agreement on certainkey matters. Reluctantly, we decided that we had no viable optionbut to withdraw the drugvoluntarily.

Having withdrawn the drug, we had . . . [Full text of this article]

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