Asociación de los eventos adversos con medicamentos biológicos registrados en el Instituto Nacional de Vigilancia de Medicamentos y Alimentos INVIMA 2014

Abstract

The function allows post-marketing pharmacovigilance monitoring of drugs and biologicals admitted receiving records of adverse events and generating changes, alerts, signals, allowing the modification of the pharmacological information, management, and even marketing suspension of medicines biologics and allowed to flow. Through this process of pre-registration and post-marketing clinical studies, qualitative and quantitative analyzes are performed, signals and alerts are generated, and the safety profile, important in handling any medicine tool for health personnel even for the patient. The possible association of the adverse reaction to the drug creates the signals; causing changes in marketing and quality depend on the registry, improving safety and quality of life of patients. Biological products, a portion of newly introduced drugs and commercial interests deserve special attention, given their potential and manufacturing. In this study, the possible association between the main adverse reactions recorded in INVIMA analyzed, creating possible signals regarding the first five biological products, and making comparison with the safety profiles of the main international reference agencies. similarity was found with reference safety profiles internationally, and possible signals, but do not have causality, and are evident in most possible, serve as starting point for further research were created.