title: Ischemic Colitis as a Complication of Medication Use: An Analysis of the Federal Adverse Event Reporting System.
abstract: More than one decade ago, rising cases of ischemic colitis (IC) prompted the Federal Drug Administration to revoke alosetron's approval as treatment of irritable bowel syndrome (IBS). The aim of this study was to identify medical therapies associated with development of IC.
  
  
  
  The Federal Adverse Event Reporting System was queried for the time between January 2004 and September 2015. We identified reports listing IC as treatment complication and extracted suspected causative and concomitantly administered drugs, indications for their use and outcomes.
  
  
  
  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-inflammatory 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 patient's death with male sex and older age predicting fatal outcomes.
  
  
  
  Beyond confirming known risks of IC, the results identified 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.
authors.affiliation: Division of Gastroenterology, University of Pittsburgh Medical Center, Pittsburgh, PA, 15213, USA. bielefeldtk@upmc.edu.
authors.forename: Klaus
authors.identifier: 0000-0003-4972-6518
authors.initials: K
authors.lastname: Bielefeldt
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000367:Age Factors; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects; D000925:Anticoagulants / Q000009:adverse effects*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D014150:Antipsychotic Agents / Q000009:adverse effects; D001327:Autoimmune Diseases / Q000188:drug therapy; D050071:Bone Density Conservation Agents / Q000009:adverse effects; D002243:Carbolines / Q000009:adverse effects; D017091:Colitis, Ischemic / Q000139:chemically induced* / Q000453:epidemiology / Q000401:mortality; D003113:Colonoscopy; D016208:Databases, Factual; D004164:Diphosphonates / Q000009:adverse effects; D004967:Estrogens / Q000009:adverse effects*; D005260:Female; D012739:Gonadal Steroid Hormones / Q000009:adverse effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D007211:Indoles / Q000009:adverse effects; D007372:Interferons / Q000009:adverse effects; D043183:Irritable Bowel Syndrome / Q000188:drug therapy; D054368:Laxatives / Q000009:adverse effects; D008297:Male; D001523:Mental Disorders / Q000188:drug therapy; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D010024:Osteoporosis / Q000188:drug therapy; D011300:Preoperative Care; D018490:Serotonin Agents / Q000009:adverse effects*; D012702:Serotonin Antagonists / Q000009:adverse effects; D017366:Serotonin Receptor Agonists / Q000009:adverse effects; D012737:Sex Factors; D014363:Tryptamines / Q000009:adverse effects; D014481:United States / Q000453:epidemiology
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000925:Anticoagulants; D000970:Antineoplastic Agents; D014150:Antipsychotic Agents; D050071:Bone Density Conservation Agents; D002243:Carbolines; D004164:Diphosphonates; D004967:Estrogens; D012739:Gonadal Steroid Hormones; D007166:Immunosuppressive Agents; D007211:Indoles; D054368:Laxatives; D018490:Serotonin Agents; D012702:Serotonin Antagonists; D017366:Serotonin Receptor Agonists; D014363:Tryptamines; C090840:alosetron; C105050:tegaserod; D007372:Interferons
keywords: Alosetron; Colonoscopy; Interferon; Tegaserod; Treatment complication; Triptans