Prescrição e utilização da talidomida em área urbana no Nordeste do Brasil

Abstract

In result of new knowledge on its mechanism of action and pharmacological properties, thalidomide has been used for a number each bigger of professionals, for most diverse clinical conditions. Because of its high teratogenical potential, its safe and rational use requires an accompaniment for rigorous program of pharmacovigilance. The objective of this study was to evaluate the therapeutical prescription and the use of thalidomide in north-eastern urban area of Brazil. The data were gotten from the prescription archives of a Center of Reference for Leprosy of the Health Department and information gotten through the application of half-structuralized questionnaires the 94 users and 20 medical prescritores of thalidomide, during the period of January 2005 to July 2006. The majority of the users (70%) were men, with age between 41 and 65 years (40.7%), the main indication was the Erythema Nodosum Leprosum (70%), and 29.4% of prescriptions were prescribed for dermatologists. Between the interviewed women, more than the half were in fertile age, 85% use contraceptive method, it being the tubal ligation in 47%. Teratogenicity risk is alerted to the patient by 85% of the prescritores. The medicine was considered efficient for 70.9% of the interviewed users and the sleepiness was related as adverse effect for 80% of them. It is concluded that thalidomide is used mainly for the official indications of the Health Department, however is evident the magnifying of its clinical use for numerous conditions off label, with considerable effectiveness and light or moderate adverse effects. Although the prescritores were worried about the contraception during the treatment, when thalidomide is used in women with pregnancy risk; the determination of the ANVISA about prescription and use of thalidomide has not being adequately followed, observing that the users are inadequately informed about the adverse effect of the medicine. It’s urgent the necessity of the regulation of Law 10,651, inside of the new reality of use of thalidomide, in order to its rational and controlled clinical use.