High frequency of skin reactions in patients with leishmaniasis treated with meglumine antimoniate contaminated with heavy metals: a comparative approach using historical controls.
We analyzed data from historical controls treated with meglumine antimoniate to compare the frequency of adverse events observed in patients with cutaneous leishmaniasis treated with the same dose of meglumine antimoniate contaminated with heavy metals in an endemic area of the State of Bahia, Brazil. Group A patients were treated in 2000 with the drug produced by Eurofarma Laborat rios Ltda., S o Paulo, Brazil (lot A) and group B patients were treated in 1996 with the reference drug produced by Rhodia Farma Ltda., S o Paulo, Brazil (lot B). We observed an unusual higher frequency of skin reactions in group A patients. However, all type of adverse events observed in group A were also observed in group B. The physico-chemical analysis of these lots revealed that lot A had lower pH and higher concentration of total and trivalent antimony, lead, cadmium, and arsenic. Our findings suggest that the skin reactions could be attributed to heavy metal contamination of lot A.
Romero
Gustavo Adolfo Sierra
GA
Núcleo de Medicina Tropical, Universidade de Brasília, Brasília, DF, 70919-970, Brasil. gromero@unb.br
Flores  M
Rico Marlon de Moraes
RM
Noronha
Elza Ferreira
EF
Macêdo
Vanize de Oliveira
Vde O
D000981:Antiprotozoal Agents / Q000009:adverse effects* / Q000737:chemistry; D001151:Arsenic / Q000009:adverse effects* / Q000032:analysis; D002104:Cadmium / Q000009:adverse effects / Q000032:analysis; D016022:Case-Control Studies; D016009:Chi-Square Distribution; D004340:Drug Contamination; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007854:Lead / Q000009:adverse effects / Q000032:analysis; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy*; D008297:Male; D008536:Meglumine / Q000009:adverse effects* / Q000737:chemistry; D000077485:Meglumine Antimoniate; D019216:Metals, Heavy / Q000009:adverse effects* / Q000032:analysis; D009942:Organometallic Compounds / Q000009:adverse effects* / Q000737:chemistry; D009994:Osmolar Concentration; D018709:Statistics, Nonparametric
D000981:Antiprotozoal Agents; D019216:Metals, Heavy; D009942:Organometallic Compounds; D002104:Cadmium; D007854:Lead; D008536:Meglumine; D000077485:Meglumine Antimoniate; D001151:Arsenic