Abstract

PHARMACOVIGILANCE APPROACHES TO MITIGATE ADRS IN PAIN MANAGEMENT DRUGS: THE CASE OF ROFECOXIB

Juned Ali*, Nancy Badlani, Kailash Kumar

ABSTRACT

Pain management has undergone great strides with the introduction of NSAIDs and selective COX-2 inhibitors like rofecoxib, designed to relieve pain and inflammation but with minimum gastrointestinal side effects. But the case of world-wide withdrawal of rofecoxib in 2004 due to cardiovascular risks - myocardial infarction and stroke -illustrates the double-edged sword of drug innovation. This review goes into the pharmacovigilance strategies that have identified these risks, including clinical trials, post-marketing surveillance, and spontaneous reporting systems. Regulatory authorities' pivotal role in assessment and action of safety signals is illustrated in light of lessons learned from rofecoxib's case. Using its path from market launch to withdrawal, this review will illuminate a comprehensible value of effective drug safety surveillance and outline the negative ADR effects of rofecoxib so that learnings may be gleaned for future applications in the pain managementclass. The rofecoxib case study forms a solid foundation for the advancement of transparency, ethical behavior, and proactive pharmacovigilance in drug development and regulation.

Keywords: 1. Rofecoxib 2. COX-2 Inhibitors 3. Pharmacovigilance 4. Cardiovascular Adverse Effects 5. Post-Marketing Surveillance 6. Drug Safety Regulation