Lotronex re-entry?
Executive Summary
"Odds are low that we would see Lotronex reintroduced because of the pretty high standard that the FDA is imposing on the predictability of side effects," GSK CEO Garnier says. FDA wants company to find a way to identify patients who are at risk for ischemic colitis and severe constipation (1"The Pink Sheet" April 23, p. 10). "We know for a fact that there's no easy way to predict who might suffer from an episode of colitis and who might not. When you look at the few cases we have had, there's no pattern," Garnier says. "So I'm not too optimistic, but we're still in discussions"
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