Tapentadol: navigating the complexities of abuse, patient safety & regulatory measures.

Aim: To evaluate tapentadol abuse cases by analyzing real-world data and identifying under-reporting countries from Southeast Asian Region (SEAR) to enhance vigilance.

Method: A retrospective, observational study from 2013 to March 2024 using VigiBase was conducted.

Result: Tapentadol-related abuse falls within the System Organ Class (SOC) categories of psychiatric disorder, nervous system disorder and injury, poisoning, and procedural complications. These are further categorized into Preferred Terms (PT) such as anxiety, delirium, Central Nervous System toxicity, depressive disorder, drug abuse, dependence/withdrawal syndrome, and overdose using the Medical Dictionary for Regulatory Activities (MedDRA) system. Among the 11 countries in the SEAR, India is the only country to report cases of tapentadol-related abuse, no Individual Case Safety Reports (ICSRs) related to tapentadol abuse have been submitted from other SEAR nations. Out of 127 ICSRs concerning tapentadol-related adverse events reported in India, 20 cases involved abuse. Focusing on the ICSRs submitted in India, the reported adverse reactions included anger(n = 1,10%), anxiety (n = 2, 10%), delirium (n = 1, 5%), drug abuse (n = 4, 20%), drug dependence/withdrawal syndrome (n = 7, 35%), intentional overdose (n = 2, 10%), depressive disorder (n = 1, 5%), euphoric mood (n = 1, 5%), and product misuse (n = 1, 5%) indicating a concerning pattern of substance abuse.

Conclusion: Stringent regulatory actions are needed to curb this practice in India, such as rescheduling tapentadol from Schedule H (Prescription drugs) to Schedule X(Narcotic drugs) in India could offer more regulatory oversight and measures to reduce risks related to abuse, addiction, and dependence while enhancing patient safety in pain management practices. Additionally, tapentadol should be closely monitored in other SEAR countries due to its potential for dependence. This study also emphasizes the importance of encouraging SEAR countries to report more Adverse Drug Reactions (ADRs), which would facilitate the implementation of more rigorous regulatory measures.