Eventos adversos em pacientes com Eritema NodosoHansênico em uso de Talidomida

Abstract

Introduction: Thalidomide is used for treatment of Erythema NodosumLeprosum (ENL) in Hansens disease patients, among other indications. In Brazil, the drug is manufactured by a national public manufacturer and its use is strictly controlled by the health regulatory agency (Anvisa), due to its teratogenicity potential. Objective: To determine the frequency of thalidomide adverse events (AE) in ENL patients and to evaluate the activities related to its prescription, dispensing and pharmacovigilance. Method: A two-component, cross-sectional study. In Component 1, patients attended at a reference service in infectology in Minas Gerais - Eduardo de Menezes Hospital, were interviewed about AE related to thalidomide and sociodemographic and clinical variables. Descriptive analyzes were performed to characterize the study population in relation to AE and exposure variables. The magnitude of the association was calculated using odds ratios with 95% confidence intervals, through logistic regression. In Component 2, a diagnosis was made of thefunctioning and articulation between the referral hospital in infectious diseases in Minas Gerais, the drugs national public manufacturer and the sanitary regulatory agency, involved in the control of the use of thalidomide, care and monitoring of users within the scope of the Brazilian Unified Health System (SUS). Interviews were conducted with health professionals from the hospital about the service related thalidomide. The reports of thalidomide AE referring to all indications of thalidomide use registered by the Customer Service of the public manufacturer (2014-2016) and of the Anvisa pharmacovigilance service(2010-2016) were obtained. Results: In Component 1, 110 patients wereinterviewed. The majority were men (65.5%) with mean age of 47.8 years, low family income and schooling. The mean duration of treatment with thalidomide was three years. Most frequent AE were dry skin (95.5%), paresthesia (86.4%), pain (84.7%), drowsiness (77.3%) and weight gain (66.4%). About 9% of the patients presented thrombosis during treatment and there were no reports of teratogenicity. Gender was independently associated with thrombosis; schooling up to elementary school and polypharmacy with > 11 AE; and polypharmacy with paresthesia, weakness, sequelar neuropathy and edema. Women of childbearing age used contraception to ensure that pregnancy did not occur during treatment; however, not all patients reported using a condom. In Component 2, 20 hospital health professionals were interviewed. All were aware of the main indications for thalidomide and 80% knew the main adverse reactions to thalidomide. None of the professionals had reported AE to health surveillance, nor had they contacted Customer Service. In three years, 330 contacts related to thalidomide were registered via Customer Service, 7% of which were related to AE. In almost six years, only 15 notifications were made to the regulatory agency, with ten considered serious and three on peripheralneuropathy. The number of AE found in Component 1 was much higher incomparison to the number notified to Anvisa and received via SAC from the official laboratory manufacturer. Conclusions: AE were very common in thalidomide patients, highlighting symptoms of peripheral neuropathy and thrombosis. Despite the risk of teratogenicity, serious adverse reactions, the required accuracy in controlling its use, the pharmacovigilance of thalidomide remains incipient in the country.