Furthermore, during the study, at least four instances of ischemic colitis occurred in the clinical trial among the patients taking Lotronex. No instances of ischemic colitis occurred among the patients taking the placebo during the same clinical trials. There were an additional three patients taking Lotronex in the clinical trial who experienced unexplained rectal bleeding which one medical reviewer for the Federal Drug Administration suggested could also be linked to ischemic colitis. Ischemic colitis itself is a rare disorder and incidence in the general population is approximately three out of ten thousand people. Thus, in the clinical trials, the incidence of ischemic colitis was actually four out of nine hundred, perhaps even as high as seven out of nine hundred, a substantial increase in the incidence.
Ischemic colitis occurs as the result of reduced blood flow to the intestines.
It can result in severe injuries, including bowel perforation, bowel obstruction, segmental gangrene, peritonitis, and even death if the dead bowel is not removed in time. Despite the incidence of ischemic colitis in the clinical trials, Glaxo Wellcome went ahead on the FDA fast track to put the drug on the market. Following the release of Lotronex on the market in March, the FDA advisory panel that approved Lotronex reconvened in June for reconsideration of the drug. This was prompted by reports the FDA received of a number of events of dangerous ischemic colitis. The FDA proposed a warning displayed in a black border to accompany the drug.