Rev. Soc. Esp. Dolor. 2023; 30(4): 210-216 / DOI: 10.20986/resed.2023.4025/2022
Melissa Reyes, Carlos Hernán Rodríguez, Bilena Margarita Molina, Gabriel David Pinilla
ABSTRACT
Introduction: Acute pain is highly prevalent in The Hospital Settings and in the emergency department. Dipyrone (metamizole) is a widely used medication for acute pain syndromes, such as postoperative pain. This study aims to characterize the adverse drug reactions (ADRs) most frequently associated with dipyrone.
Materials and methods: This is a study based on records in the Colombian database of the National Institute for Food and Drug Surveillance (INVIMA). Incidences were calculated and characteristics related to non-recoverable ADRs were determined.
Results: A total of 1833 prescriptions of dipyrone were recorded, corresponding to 4021 medication-related problems (3868 ADRs, 96.19 %). The incidence of MRP due to dipyrone was 101 per 100,000 unique prescribed patients. Women accounted for 54.55% of the patients, and the median age was 28 years (IQR 10-46). The most frequent ADRs were skin rash (905; 24.78 %), pruritus (561; 15.36 %), and urticaria (365; 9.99 %). Thirtyeight ADRs affected the hematologic system (0.98 %). Hematologic ADRs in women had a higher probability of non-recovery (OR 14.52 IQR 5.25-40.20; p = 0.000).
Conclusions: In Colombia, the most common ADRs associated with dipyrone affect the skin and its appendages. Unlike the incidence in patients of other ethnicities, hematologic ADRs are rare but are associated with a lower probability of recovery.
RESUMEN
Introducción: El dolor agudo es altamente prevalente en el ámbito hospitalario y en el servicio de urgencias. La dipirona (metamizol) es un medicamento ampliamente utilizado para el tratamiento de síndromes dolorosos agudos, como el dolor postoperatorio. Principalmente, esta investigación busca caracterizar los problemas (PRM) y las reacciones adversas medicamentosas (RAM) más frecuentemente asociadas con la dipirona.
Materiales y métodos: Este es un estudio de los registros de farmacovigilancia incluidos en la base de datos del Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) de Colombia. Se describieron los PRM y se calculó su incidencia. Además, se determinaron las características relacionadas con RAM no recuperables.
Resultados: Se registraron 1833 prescripciones de dipirona que correspondían a 4021 problemas relacionados con los medicamentos (3868 RAM, 96,19 %). La incidencia de PRM por dipirona fue de 101 por cada 100.000 pacientes únicos prescritos. El 54,55 % de los pacientes fueron mujeres y la mediana de edad fue de 28 años (IQR 10-46). Las RAM más frecuentes fueron erupción cutánea (905; 24,78 %), prurito (561; 15,36 %) y urticaria (365; 9,99 %). 38 RAM comprometieron el sistema hematológico (0,98 %). Las RAM hematológicas en mujeres tuvieron una mayor probabilidad de no recuperación (OR 14,52 IQR 5,25-40,20; p = 0,000).
Conclusiones: En Colombia, las RAM asociadas con dipirona más comunes comprometen la piel y anexos. A diferencia de la incidencia en pacientes de otras etnias, las RAM hematológicas son poco frecuentes, aunque sí se asocian con una menor probabilidad de recuperación.
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