Adverse drug reactions to thalidomide in hansen’s disease patients

• Autor(a) principal: Cristiane Aparecida Menezes de Pádua
• Data de Publicação: 2017
• Outros Autores: Paula Lana de Miranda Drummond, Roberta Márcia Marques dos Santos
• Tipo de documento: Artigo de conferência
• Idioma: eng
• Título da fonte: Repositório Institucional da UFMG
• Texto Completo: https://doi.org/10.1002/pds.4275; http://hdl.handle.net/1843/46519
• topic: Reações adversas a medicamentos; Talidomida; Hanseníase; Reações adversas a medicamentos; Hanseníase

Background: In Brazil, thalidomide (TLD) is the firstline treatment for Erythema Nodosum Leprosum (ENL) in patients with Hansen’s disease. The lack of information concerning adverse drug reactions (ADR) related to TLD and the incipient surveillance has motivated this study. Objectives: To estimate the frequency of ADR associated with TLD use in patients with ENL. In addition, issues related to prescription, dispensing and pharmacovigilance activities of TLD were evaluated. Methods: Cross-sectional study involving patients attending dermatologic clinics of a public referral hospital for infectious diseases in Minas Gerais State, Brazil. All patients (≥18 years) using TLD for ENL between July and October 2016 were invited to participate in the study. Patients were interviewed and asked to respond to questions about sociodemographic variables, variables related to their health state, understanding of TLD treatment, accordance with national regulatory law, and ADR experienced during the treatment. Results: A total of 110 patients were interviewed. Most were men (65.5%) aged on average 47.8 years old. The mean length of TLD use was 37.3 months. Twenty-three out of 38 women reported the use of injectable medroxyprogesterone, 16.7% had been submitted to a previous sterilization procedure, 19.4% were not in fertile age, and 33.7% of patients referred condom use. Approximately 80.0% of the patients knew they used TLD for ENL or Hansen’s disease whereas 19.3% were not aware about the reason of TLD’s use. Most ADR comprised dry skin (94.6%), paresthesia (82.7%), somnolence (77.3%), weight gain (66.4%), tremor (60.9%), adynamia (60.0%), pain (52.7%), dry mouth (52.7%), anxiety (52.7%), impotence (25.5%), lower limb edema (20.9%) and thrombosis (6.4%). Conclusions: ADR were very common among TLD patients. Women in fertile age are under contraceptive use to ensure birth control, but not all patients reported the use of condom. Apparently, most patients understand the need of TLD and perceive the main adverse effects.