Adverse events associated with tramadol and dipirona administration in a level III hospital
Keywords:
Dipyrone/adverse effects, tramadol/adverse effects, drug costs pharmaco-epidemiology
Abstract
Introduction. The efficacy and safety of pharmaceutical drugs such as dipirone and tramadol must be a primary objective in the post-marketing period and as they are used in specific population groups.Objectives. The frequency of adverse effects (including therapeutic failure) with the medications tramadol and dipirona were described and estimated.
Material and methods. At the Hospital Universitario de la Samaritana, Bogotá, D.C., Colombia, adverse events associated with dipirone and tramadol were rigorously tracked in patients hospitalized in the internal medicine, as well as the orthopedics and surgery departments. For a period of six months, data were collected by means of the Instituto Nacional de Vigilancia Médica y Alimentos (INVIMA) standard report form. Direct costs of adverse event treatment to the patient were calculated.
Results. Adverse reactions were detected 213 times in 171 (8.4%) of the 2,547 patients admitted to the services (incidence rate. Of these instances, 53.4% were rated as possible for dipirone and 46.82% for tramadol. Of the total, 0.6% (16 cases) were classes as serious adverse events. The gastrointestinal system was the most affected, with the incidences of adverse events for dipirone of 27%) and tramadol of 42.9%. The total cost generated by the medical response to the 213 adverse events was estimated to be US$14,346.53.
Conclusions. An unacceptable level of preventable adverse events was described that impacted the well-being of patients, as well as the costs associated with remedial treatment. These data recommend that institutional pharmacovigilance programs be required.
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References
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2. Schönhöfer P, Offerhaus L, Herxheimer A. Dipyrone and agranulocytosis: what is the risk? Lancet. 2003; 361:968-9.
3. Plager M. Las preguntas más frecuentes acerca de Novalgina®. Sanofi-Aventis. Fecha de consulta: 5 de noviembre de 2006. Disponible en: http://en.sanofi-aventis.com/publications/publications.asp
4. Edwards JE, McQuay HJ. Dipyrone and agranulocytosis: what is the risk? Lancet. 2002:360:1438.
5. Sollero L. Incidence of agranulocytosis and the use of dipyrone in Brazil. Rev Bras Pesquisas Med Biol. 1976;9:79-86.
6. Hamerschlak N, Maluf E, Pasquini R, Eluf-Neto J, Moreira FR, Cavalcanti AB, et al. Incidence of aplastic anemia and agranulocytosis in Latin America: the LATIN study. Sao Paulo Med J. 2005;123:101-4.
7. Grond S, Sablotzki A. Clinical pharmacology of tramadol. Clin Pharmacokinet. 2004;43:879-923.
8. Tribiño G, Maldonado C, Segura O, Díaz J. Costos directos y aspectos clínicos de las reacciones adversas a medicamentos en pacientes hospitalizados en el servicio de medicina interna de una institución de tercer nivel de Bogotá. Biomédica. 2006;26:31-41.
9. Grupo de Farmacovigilancia INVIMA/UN. Boletín de Farmacovigilancia. No. 11. Fecha de consulta: 28 de septiembre 28 de 2006. Disponible en http://web.invima.gov.co/Invima//farmacovigilancia/docs_boletines/BOLETIN%2011.pdf
10. Segura O, Maldonado C. Las reacciones adversas a medicamentos: una aproximación desde el punto de vista económico. Biomédica. 2003;23:401-7.
11. Hunziker T, Bruppacher R, Kuenzi U, Maibach R, Braunschweig S, Halter F, et al. Classification of ADRs: a proposal for harmonization and differentiation based on the experience of the Comprehensive Hospital Drug Monitoring Bern/St. Gallen, 1974-1993. Pharmacoepidemiol Drug Saf. 2002;11:159-63.
12. Londoño A. PR Vademecum 2008. 7ª edición. Bogotá: Licitelco S.A.; 2007.
13. Dólar HOY. Cotización del dólar en Colombia. Fecha de consulta: 24 de marzo de 2008. Disponible en: http://www.wilkinsonpc.com.co/free/dolar-hoy.html.
14. Pucino F, Beck CL, Seifert RL, Strommen GL, Sheldon PA, Silbergleit IL. Pharmacogeriatrics. Pharmacotherapy. 1985;5:314-26
15. Dennis R, Gutiérrez JM, Rodríguez MN. Creación de un programa piloto de farmacovigilancia en el Hospital Universitario San Ignacio. Acta Médica Colombiana. 1998;23:15-22.
16. Katzung BG, Bertram G. Farmacología básica y clínica. 10ª edition. East Norwalk: Mc Graw Hill/Appleton & Lange; 1996.
17. Cadieux RJ. Drug interactions in the elderly. How multiple drug use increases risk exponentially. Postgrad Med. 1989;86:179-86.
18. Schneider JK, Mion LC, Frengley JD. Adverse drug reactions in an elderly outpatient population. Am J Hosp Pharm. 1992;49:90-6.
19. Carty MA, Everitt DE. Basic principles of prescribing for geriatric outpatients. Geriatrics. 1989;44:85-98.
20. Carnevali DL, Patrick M. Nursing management for the elderly. 2ª edition. Philadelphia: JB Lippincott Co; 1986.
21. García-Martínez JM, Fresno JA, Lastres P, Bernabéu C, Betés PO, Martín-Pérez J. Effect of metamizol on promyelocytic and terminally differentiated granulocytic cells. Comparative analysis with acetylsalicylic acid and diclofenac. Biochem Pharmacol. 2003;65:209-17.
22. Laporte JR, Capella D. Métodos aplicados en estudios descriptivos de utilización de medicamentos. En: Laporte JR, Tognoni G, editores. Principios de epidemiología del medicamento. 2ª edición. Barcelona: Ediciones Técnicas y Científicas S.A; 1993. p. 68-9.
23. Carbonin P, Pahor M, Bernabei R, Sgadari A. Is age an independent risk factor of adverse drug reactions in hospitalized medical patients? J Am Geriatr Soc. 1991;39:1093-9.
24. Nolan L, O’Malley K. Prescribing for the elderly. Part I: Sensitivity of the elderly to adverse drug reactions. J Am Geriatr Soc. 1988;36:142-9.
25. Leape LL, Brennan TA, Laird N, Lawthers AG, Localio AR, Barnes BA, et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med. 1991;324:377-84.
How to Cite
1.
Montoya G, Vaca C, Parra MF. Adverse events associated with tramadol and dipirona administration in a level III hospital. biomedica [Internet]. 2009 Sep. 1 [cited 2024 May 16];29(3):369-81. Available from: https://revistabiomedica.org/index.php/biomedica/article/view/9
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