Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil

Fernanda Sales Luiz Vianna; Marcelo Zagonel de Oliveira; Maria Teresa Vieira Sanseverino; Elaine Faria Morelo; Dacio de Lyra Rabello Neto; Jorge Lopez-Camelo; Suzi Alves Camey; Lavinia Schuler-Faccini

doi:10.1016/j.reprotox.2015.03.007

Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil

Reprod Toxicol. 2015 Jun:53:63-7. doi: 10.1016/j.reprotox.2015.03.007. Epub 2015 Mar 28.

Authors

Fernanda Sales Luiz Vianna¹, Marcelo Zagonel de Oliveira², Maria Teresa Vieira Sanseverino³, Elaine Faria Morelo⁴, Dacio de Lyra Rabello Neto⁵, Jorge Lopez-Camelo⁶, Suzi Alves Camey⁷, Lavinia Schuler-Faccini⁸

Affiliations

¹ 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.
² INAGEMP - Instituto Nacional de Genética Médica Populacional, Porto Alegre, Brazil; Genetics Department, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
³ INAGEMP - Instituto Nacional de Genética Médica Populacional, Porto Alegre, Brazil; Teratogen Information Service, Medical Genetics Service, Hospital de Clínicas de Porto Alegre, Brazil.
⁴ Programa Nacional da Hanseníase, Brasília, Brazil.
⁵ Secretaria de Vigilância em Saúde, Ministério da Saúde, Brasília, Brazil.
⁶ 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.
⁷ Postgraduate Program in Epidemiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.
⁸ 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.

PMID: 25828060
DOI: 10.1016/j.reprotox.2015.03.007

Abstract

Introduction: 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.

Keywords: Birth defects surveillance; INAGEMP; Limb reduction defects; Pharmacoepidemiology; Thalidomide embryopathy.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Abnormalities, Drug-Induced / epidemiology*
Brazil / epidemiology
Drug Prescriptions / statistics & numerical data
Female
Humans
Infant, Newborn
Leprosy / drug therapy
Leprosy / epidemiology
Phenotype
Pregnancy
Prevalence
Thalidomide / adverse effects*

Substances

Thalidomide