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Web End = Dig Dis Sci (2016) 61:26552665 DOI 10.1007/s10620-016-4162-x
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Web End = ORIGINAL ARTICLE
Ischemic Colitis as a Complication of Medication Use: An Analysis of the Federal Adverse Event Reporting System
Klaus Bielefeldt1
Received: 13 March 2016 / Accepted: 4 April 2016 / Published online: 12 April 2016 Springer Science+Business Media New York 2016
AbstractBackground More than one decade ago, rising cases of ischemic colitis (IC) prompted the Federal Drug Administration to revoke alosetrons approval as treatment of irritable bowel syndrome (IBS). The aim of this study was to identify medical therapies associated with development of IC.
Methods The Federal Adverse Event Reporting System was queried for the time between January 2004 and September 2015. We identied reports listing IC as treatment complication and extracted suspected causative and concomitantly administered drugs, indications for their use and outcomes.
Results After eliminating duplicates, we found 2811 cases of IC (68.4 % women; 59.4 0.4 years). Patients with IBS accounted for 3.9 % of the cases, mostly attributed to tegaserod or alosetron. Chemotherapeutic and immunosuppressive drugs, sex hormones, and anticoagulants were the most commonly suspected causes. Bisphosphonates, nonsteroidal anti-inammatory drugs, antipsychotics, triptans, interferon therapy, and laxative use prior to colonoscopy were among the more commonly listed treatments. In 8 %, the adverse event contributed to the patients death with male sex and older age predicting fatal outcomes. Conclusion Beyond conrming known risks of IC, the results identied several potential culprits of ischemic
colitis. This information may not only explain the development of this serious adverse event, but could also guide treatment decisions, cautioning healthcare providers when considering these agents in persons with known risk factors or other drugs that may increase their risk of IC.
Keywords Tegaserod Alosetron Triptans
Colonoscopy Interferon Treatment complication
Introduction
While ischemic colitis is a known complication of cardiovascular and major abdominal surgery, many sporadic cases manifest in individuals without such predisposing conditions [1, 2]. Colonic ischemia in the perioperative time often affects older individuals with signicant comorbidities and carries a high morbidity and mortality [36]. This outlook differs signicantly from the much more benign course seen in scenarios not associated with major surgeries or episodes of circulatory collapse. Case series focusing on such cohorts consistently describe a subgroup of...