title: The safety of novel drugs used to treat irritable bowel syndrome.
abstract: BACKGROUND
  Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder with a high prevalence. Besides efficacy, the safety of each drugs used to treat GI disorders is an important issue in the drug development process.
  
  
  METHODS
  This article reviews all Phase I to IV clinical trials or case reports with results related to the safety of novel GI drugs. The drugs are currently approved or under evaluation for approval.
  
  
  CONCLUSIONS
  Most of the reported adverse events were related to the GI tract with mild-to-moderate severity. Diarrhea was significantly higher versus placebo following use of linaclotide and renzapride, similar to that of constipation with ramosetron. Lubiprostone, linaclotide and rifaximin with low systemic bioavailability have less adverse events and exert more advantageous results. Asimadoline acts peripherally on κ-opioid receptors and is not associated with CNS side effects. As lubiprostone and linaclotide cause dose-dependent adverse events, starting the treatment with the lowest effective doses is advised. Ramosetron is under evaluation for diarrhea-predominant IBS due to its acceptable safety and tolerability, besides its efficacy. Rifaximin, asimadoline and renzapride are still in need of more long-term studies regarding their safety.
authors.affiliation: Tehran University of Medical Sciences, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Department of Toxicology and Pharmacology , Tehran, 1417614411 , Iran +98 21 66959104 Mohammad.Abdollahi@UToronto.Ca , mohammad@tums.ac.ir.
authors.forename: Shilan
authors.initials: S
authors.lastname: Mozaffari
authors.forename: Shekoufeh
authors.initials: S
authors.lastname: Nikfar
authors.forename: Mohammad
authors.initials: M
authors.lastname: Abdollahi
mesh_terms: D005765:Gastrointestinal Agents / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic
chemical_list: D005765:Gastrointestinal Agents