Pharmacovigilance in tuberculosis: pilot experience of a Reference Center of Rio de Janeiro, Brazil

Introduction: Pharmacovigilance is a set of activities that aims to identify, evaluate, understand and prevent possible adverse events (AE) in the use of drugs through the early detection of safety related problems. Objective: To describe the experience of the pilot project of Pharmacovigilance in Tuberculosis carried out at the Professor Helio Fraga Reference Center - ENSP/ Fiocruz, Brazil from July 2013 to February 2014. Results: We evaluated 15 reports where the main AE found were: Polyarthralgia (2); Peripheral neuropathy (1); Joint pain (5), one of these with insomnia; arthralgia (2); change in visual acuity (1); diarrhea (3); vomiting, headache, joint pain and nausea (1). The analyzed variables were: Severity, Non-serious, Adopted procedures and Suspicious drugs: Severity = eleven were clinically important and, among them, one was reported as persistent or significant disability. Non-severe = four notifications described. Proceedings adopted = four reports with interruption of the suspected drug; in four the dose was reduced and in seven the dosage was maintained. Suspected medicines = Levofloxacin was the most prescribed drug suspected of causing AE. Conclusions: The results showed that some drugs used in the treatment of resistant tuberculosis are more likely to cause AE. There is a need to adopt measures where medicines are the object of permanent attention.