Retirada do Rofecoxibe (Vioxx) do mercado : análise dos impactos na saúde cardiovascular e regulação de medicamentos : uma revisão de literatura

Abstract

Introduction: The process of introducing new drugs to the market is complex and highly regulated, involving stages from initial research to development. The approval of new drugs is crucial to ensure human safety, and the detection of adverse drug reactions is vital, as these unwanted reactions can vary in severity and nature, ranging from mild effects to serious health problems. Rofecoxib (Vioxx) was initially marketed as safe but was later withdrawn from the market due to cardiovascular risks. This incident had a significant impact on the pharmaceutical industry and led to stricter regulations. Objective: To conduct a literature review on the consequences of the withdrawal of Rofecoxib (Vioxx) from the market, focusing on cardiovascular health and drug regulation. Methodology: This work is a descriptive literature review that analyzes the impacts of the withdrawal of the drug Rofecoxib from the market and its effects on cardiovascular health. The sampling included data from sources such as Lilacs, PubMed, Scielo, Google Scholar, monographs, and research related to the topic. The study was conducted from March to November 2023. Theoretical Framework: The withdrawal of Rofecoxib from the market due to cardiovascular safety concerns led to changes in medical prescription practices, especially in patients with pre-existing cardiovascular risk factors. The withdrawal of Rofecoxib also had an impact on pharmaceutical regulations, with regulatory agencies adopting stricter approaches to evaluating the cardiovascular safety of drugs. Conclusion: The case of Rofecoxib underscores the importance of drug safety and its impact on cardiovascular health. This has influenced the development, evaluation, and monitoring of drugs, with profound implications for the pharmaceutical industry and drug regulation. The episode highlighted the complexity of the new drug approval process and the need for ongoing monitoring after launch. Pharmaceutical regulations have evolved, with regulatory agencies imposing stricter standards on clinical trials and post-market monitoring.