Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil.

SANSEVERINO MT, MORELO EF, DE LYRA RABELLO NETO D, LOPEZ-CAMELO J, CAMEY SA, SCHULER-FACCINI L. JORGE LOPEZ CAMELO

REPRODUCTIVE TOXICOLOGY (ELMSFORD, N.Y.)

PERGAMON-ELSEVIER SCIENCE LTD

Lugar: Amsterdam; Año: 2015 vol. 53 p. 63 - 67

0890-6238

INTRODUCTION:Thalidomide causes congenital defects in children, such as limb reductiondefects. Currently, it is used for a fewindications; 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 thedistribution of thalidomide and the prevalence of leprosy between 2005 and 2010 in Brazil.RESULTS: A total of 5,889,210 thalidomide tablets were distributed; theprevalence of limb reduction defects was 1.60 (CI95%: 1.54-1.66) and TEPwas 0.11 (CI95%: 0.10-0.13) per 10,000 births. Poisson regression showed anincrease 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 incountries where this medication is available.