In 1998, thalidomide was approved by the US FDA for the treatment of ENL and later, in 2006, for the treatment of multiple myeloma, under strict restrictions to prevent exposure in utero. Presently, the use of thalidomide is approved in many countries for the treatment mainly of ENL, skin diseases, and several types of cancer. This continuous commercialization plus its high use due to the prevalence of leprosy and inefficient drug control measures gave way to the appearance of new cases of thalidomide embryopathy between the 1970s and 1990s. Following these reports, a more restrictive regulation was created for thalidomide use and prescription in Brazil. Nevertheless, three new individuals with thalidomide syndrome were reported after that. Besides being employed in the treatment of ENL since 1965, thalidomide has been available for use in Abmole Lonidamine Brazil since the end of the 1990s for the treatment of multiple myeloma, graft-versus-host reaction, systemic lupus erythematosus, and ulcerations related to the acquired immunodeficiency syndrome, among other diseases, as long as the purpose of prescription in these situations is duly documented. Leprosy is definitely the main disease to which thalidomide has been prescribed. Brazil, with a population of 190 million inhabitants is one of the leading countries in number of leprosy cases the world, with an overall estimated prevalence of 5/ 10,000. However, regional prevalences are quite dissimilar, ranging from less than 1/10,000 in South Brazil to 7/10,000 in North and Northeast. The drug is not commercially available being distributed only through specific programs of the Ministry of Health, and dispensed following explicit and rigid rules. However, the recent discovery of babies with thalidomide embryopathy raises questions as to the effectiveness of the restricted distribution system with respect to prevention of pregnancy exposures. Generic thalidomide is produced in Brazil by just one laboratory, under supervision of the Ministry of Health. Around four million tablets of thalidomide are distributed yearly, by specific government programs, mostly for the treatment of ENL. Until 2010, there was no information about the exact destination of these tablets. This lack of information can be accountable for the recent occurrence of cases of thalidomide syndrome. From 2011, a new legislation for thalidomide dispensing was implemented in Brazil with a strong control of to whom this drug is being prescribed. However, we know that in Brazil around 24,000 cases of multibacilar leprosy are yearly diagnosed. From these, 30% to 50% will present ENL. From this estimation, approximately 10,000 individuals are possible users of thalidomide. The assessment of TEP during the baseline period enabled the establishment of a Brazilian BPR for phenotypes compatible with this syndrome, permitting the detection of increases in the frequency of TEP through the CUSUM methodology. There are no references with which to compare the rates of a sentinel phenotype as described here; however, during the surveillance period, increases in the BPRs of TEP were observed, corroborating the thalidomide distribution pattern from 2000. The differences observed in the TEP rate between the different regions of Brazil are in accordance with the distribution of leprosy across the country. In the south region, TEP was less frequent than in other regions, and so was leprosy prevalence. Furthermore, no differences between the two periods were detected.