Signal Detection Analysis of Serious Adverse Events Associated with the Digestive Disorder Treatment Agents Rx-To-OTC Switched

Abstract

Approximately 60% of individuals regularly purchase over-the-counter (OTC) drugs for digestive disorder treatment, and some switches from prescription to OTC (Rx-to-OTC) drugs are also made. Since many of these drugs are classified as first-class drugs, pharmacists need to ensure the safety by providing drug information. Therefore, we assessed the safety signals by determining the adverse drug reactions (ADRs) caused by Rx-to-OTC switched agents for treating digestive disorders.
The Japanese Adverse Drug Event Report (JADER) database entries from April 2004 to January 2015 for 14 Rx-to-OTC switched agents that were not prescribed for children were analyzed in adults more than 20 years of age. Hypersensitivity and hepatic disorders were considered to be serious ADRs. Signals in the data that indicated a drug-associated ADR were assessed using the reporting odds ratio (ROR). A lower-bound 95% two-sided confidence interval of > 1 indicated an ADR.
Signals for hepatic disorders were detected in the case of 2 Rx-to-OTC switched agents, ie, famotidine and rebamipide. Hypersensitivity was detected for donperidone and trimebutine maleate. In addition, most of these ADRs were expressed within 1 month of drug administration. These results suggest that pharmacists should dissuade individuals from taking drugs before medical consultation.