Avaliação das reações adversas dos analgésicos tapentadol, viminol e dipirona em um contexto de saúde baseado em evidência

Abstract

Analgesics are widely used, but the safety of dipyrone, viminol and tapentadol remains poorly understood. The objectives of this study were to transmit knowledge in pharmacovigilance (PV) for the implementation of a hospital service; evaluate adverse drug reactions (ADR) in the use of the three analgesics in a Pain Clinic and systematically review the safety and efficacy of viminol. In stage A, the objective was to evaluate the impact of PV training on hospital professionals. Before and after the training, the participant answered a questionnaire, counting the acquisition of knowledge in comparison to the gold standard answers. 129 professionals participated in the research. Before the training, everyone had some knowledge about PV, 7% had an average understanding, 93% revealed unsatisfactory understanding and none of the participants had satisfactory and complete understanding. The training was effective with an increase in spontaneous notifications. In stage B, the ADRs of the three analgesics were prospectively evaluated at the Santa Casa de Alfenas Pain Clinic. Patients were followed for up to 45 days, ADRs were reported and classified according to severity, mechanism, incidence and causality was determined. In 240 patients, 11 ADRs were detected related to tapentadol, seven to viminol and three to dipyrone alone. Additionally, 22 ADRs were attributed to drug interactions. The majority of ADRs were mild, uncommon, possible and all Type A. ADRs induced by viminol were associated with age, increasing the risk of ADRs by 6% with each year of age. Overall, the three analgesics were safe, with dipyrone being the safest. In stage C, the objective was to evaluate the efficacy and safety of viminol through a systematic literature review, using the question: “Is viminol more effective and safe than cyclooxygenase inhibitors and opioid analgesics in patients with acute or chronic?” The search was carried out in five databases, including 14 articles published between 1969 and 1986. The studies totaled 2,353 patients, with viminol administered predominantly orally at a dose of 60 to 280 mg/day in a single dose, for, at maximum, 40 days. In most studies, there were no significant differences in efficacy compared to active comparators, with viminol being well tolerated. The studies presented a high risk of bias and low certainty of the evidence. Therefore, new studies are needed to guide your clinical choice