Consumer group continues to scrutinize Lotrenox

Public Citizen's Health Research Group said it obtained information from the FDA about an increase in the number of reported cases of ischemic colitis in people using Lotronex, an alosetron selective 5-HT3 antagonist marketed by Glaxo Wellcome (GLX; LSE:GLXO) to treat irritable bowel syndrome (IBS). The consumer rights group founded by Ralph Nader filed a petition on Aug. 31 to remove Lotronex from the market immediately. As of Oct. 20, the group said a total of 54 reports of ischemic colitis have been received by the FDA, and 37 of the 54 cases had to be hospitalized. In addition, the group said there were 20 cases "very suspicious for ischemic colitis" that had diagnoses such as intestinal ischemia, intestinal perforation, mesenteric occulsion and gastrointestinal necrosis. Among these were four deaths, including the death of a 50 year old women who had mesenteric occulsion, the group said.

GLX Spokesperson Ramona DuBose told BioCentury that "Public Citizen confused types of ischemic colitis." Of the 300,000 different patients receiving prescriptions since the launch of the product, "only a small percentage of patients have been observed by the company to have acute transient ischemic colitis," which she said is different from the more severe mesenteric colitis. Moreover, she said none of the deaths GLX was aware of was attributable to the product. Dubose said GLX is in discussions with the FDA about educating the public about Lotronex. ...