Risk of Serious Adverse Events With Alosetron is Similar to or Less Than That Associated With Other Drugs Prescribed for Chronic GI Disorders

Abstract

Introduction: Serious adverse events (SAEs) are associated with many gastrointestinal (GI) drugs. Based on extensive safety data, patients treated with alosetron may experience a low incidence of two SAEs (ischemic colitis [IC] and complications of constipation [CoC]). However, SAEs associated with alosetron are perceived as being more frequent and serious than SAEs with other drugs used to treat chronic GI conditions. This analysis compares SAE risks associated with alosetron vs. other GI drugs. Methods: Systematic literature searches using online databases were performed to identify controlled randomized studies, retrospective studies, meta-analyses, postmarketing prospective studies, and population-based cohort studies on GI drugs used to treat chronic conditions that also included documented SAE(s) data. These safety results were compared with retrospective analyses of health claims data for alosetron SAEs of IC and CoC. Results: The table lists GI drug-associated SAE(s) and risk(s). Conclusion: Commonly used GI drugs such as metronidazole, metoclopramide, infliximab, mesalamine, and PPIs are associated with significant SAEs. Risks for these SAEs appear to be comparable to or greater than the risks of IC and CoC with alosetron. Therefore, a comprehensive assessment by prescribers of patient risk tolerance and drug safety risk, balanced against potential drug benefit, is warranted during selection of effective pharmacotherapeutic options for GI disorders. Disclosure - Dr. Lucak: Consultant for Prometheus Laboratories Inc. Dr. Nicandro: Employee of Prometheus Laboratories Inc. Dr. Earnest: Consultant for Prometheus Laboratories Inc.Table 1