title: Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil.
abstract: BACKGROUND
  Thalidomide causes congenital defects in children, such as limb reduction defects. Currently, it is used for a few indications; in Brazil, where leprosy is endemic, thalidomide is used for the treatment of erythema nodosum leprosum, and recent cases of thalidomide embryopathy have been reported.
  
  
  METHODS
  We analyzed the frequency of births with phenotypes consistent with thalidomide embryopathy (TEP) and correlated this with the distribution of thalidomide and the prevalence of leprosy between 2005 and 2010 in Brazil.
  
  
  RESULTS
  A total of 5,889,210 thalidomide tablets were distributed; the prevalence of limb reduction defects was 1.60 (CI95%: 1.54-1.66) and TEP was 0.11 (CI95%: 0.10-0.13) per 10,000 births. Poisson regression showed an increase in cases of TEP and limb reduction defects per 100,000 tablets dispensed. Clusters and geographical isolates were identified in several regions.
  
  
  CONCLUSIONS
  There is a correlation between thalidomide and TEP showing that thalidomide embryopathy should be monitored in countries where this medication is available.
authors.affiliation: INAGEMP - Instituto Nacional de Genética Médica Populacional, Porto Alegre, Brazil; Teratogen Information Service, Medical Genetics Service, Hospital de Clínicas de Porto Alegre, Brazil; Genetics Department, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil; Postgraduate Program in Epidemiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.
authors.forename: Fernanda
authors.initials: F
authors.lastname: Sales Luiz Vianna
authors.affiliation: INAGEMP - Instituto Nacional de Genética Médica Populacional, Porto Alegre, Brazil; Genetics Department, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
authors.forename: Marcelo Zagonel
authors.initials: MZ
authors.lastname: de Oliveira
authors.affiliation: INAGEMP - Instituto Nacional de Genética Médica Populacional, Porto Alegre, Brazil; Teratogen Information Service, Medical Genetics Service, Hospital de Clínicas de Porto Alegre, Brazil.
authors.forename: Maria Teresa Vieira
authors.initials: MT
authors.lastname: Sanseverino
authors.affiliation: Programa Nacional da Hanseníase, Brasília, Brazil.
authors.forename: Elaine Faria
authors.initials: EF
authors.lastname: Morelo
authors.affiliation: Secretaria de Vigilância em Saúde, Ministério da Saúde, Brasília, Brazil.
authors.forename: Dacio
authors.initials: D
authors.lastname: de Lyra Rabello Neto
authors.affiliation: ECLAMC (Latin-American Collaborative Study of Congenital Malformations) in IMBICE, Instituto Multidisciplinario de Biologia Celular, La Plata, Argentina; ECLAMC in CEMIC, Centro de Educación Médica e Investigación Clínica, Buenos Aires, Argentina.
authors.forename: Jorge
authors.initials: J
authors.lastname: Lopez-Camelo
authors.affiliation: Postgraduate Program in Epidemiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.
authors.forename: Suzi Alves
authors.initials: SA
authors.lastname: Camey
authors.affiliation: INAGEMP - Instituto Nacional de Genética Médica Populacional, Porto Alegre, Brazil; Teratogen Information Service, Medical Genetics Service, Hospital de Clínicas de Porto Alegre, Brazil; Genetics Department, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: lavinia.faccini@ufrgs.br.
authors.forename: Lavinia
authors.initials: L
authors.lastname: Schuler-Faccini
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D001938:Brazil / Q000453:epidemiology; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007918:Leprosy / Q000188:drug therapy / Q000453:epidemiology; D010641:Phenotype; D011247:Pregnancy; D015995:Prevalence; D013792:Thalidomide / Q000009:adverse effects*
chemical_list: D013792:Thalidomide
keywords: Birth defects surveillance; INAGEMP; Limb reduction defects; Pharmacoepidemiology; Thalidomide embryopathy