Even in clinical trials, Lotronex displayed a tendency towards causing ischemic colitis in patients. From the February in which Lotronex was approved until June, the FDA received seven reports of serious complications of constipation leading to hospitalization. Surgery was required to relieve some cases of extreme Lotronex constipation. Lotronex Medication Guides were issued under regulations that became effective in 1999 when Lotronex patients ended up in hospitalization and requiring surgical procedures for constipation. Since Lotronex is a drug used to treat diarrhea, these surgeries were obviously not necessary to treat conditions held before taking the drug.

Despite the FDA