Vol. 7, Issue 2, Part G (2025)

Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most extensively prescribed therapeutic agents used for the management of inflammation, pain, and fever. Despite their wide utility, numerous NSAIDs have been withdrawn from the market due to serious and sometimes fatal adverse reactions. The mechanisms of these toxicities often involve the inhibition of protective prostaglandins, hepatic enzyme interference, and metabolic idiosyncrasies that remain undetected during preclinical testing.
This review provides a detailed pharmacological and toxicological evaluation of five banned NSAIDs Nimesulide, Rofecoxib, Benoxaprofen, Phenylbutazone + Sodium Salicylate and Valdecoxib. It focuses on their mechanism of action, surveillance data, and the subsequent regulatory decisions that led to their withdrawal. Information was compiled from scientific databases, clinical trial records, and official regulatory reports to ensure an evidence-based overview.
The review emphasizes how inadequate long-term safety monitoring and insufficient post-approval vigilance contributed to delayed recognition of severe toxicities such as hepatotoxicity, cardiovascular complications, and hematologic disorders. Furthermore, it discusses the global impact of these withdrawals on the evolution of modern pharmacovigilance systems, highlighting the transition from spontaneous adverse event reporting to structured global monitoring networks.
The findings underline the critical importance of continuous post-marketing evaluation, risk-benefit analysis, and judicious prescribing practices. Understanding these historical drug withdrawals not only safeguards patient health but also provides a valuable framework for future NSAID development and regulatory oversight.