title: High dose artesunate in combination with mefloquine: pharmacovigilance in the Venezuelan Amazon.
abstract: Forty-six patients in a remote health post of Amazonas, Venezuela, accidentally received artesunate in a dose of 10 mg/kg/day combined with mefloquine. This corresponds to the upper limit of the therapeutic range recommended by the WHO (2-10 mg/kg/day). Side effects were retrospectively investigated and a pharmacovigilance report was written. The main side effects were vomiting and diarrhea. Four patients developed complications with signs of dehydration. It is suggested to re-assess the therapeutic range of artesunate when given in combination with mefloquine and to establish a worldwide centralized antimalarial toxicity reporting system.
authors.affiliation: Amazon Center for the Investigation and Control of Tropical Diseases Simón Bolívar, Autonomous Service (SACAICET), Puerto Ayacucho, Amazon State, Venezuela. wgmetzger@yahoo.com
authors.forename: W G
authors.initials: WG
authors.lastname: Metzger
authors.forename: M
authors.initials: M
authors.lastname: Magris
authors.forename: S
authors.initials: S
authors.lastname: Vivas-Martínez
authors.forename: A
authors.initials: A
authors.lastname: Giron
authors.forename: J D
authors.initials: JD
authors.lastname: Brooms
authors.forename: N
authors.initials: N
authors.lastname: Villalobos
authors.forename: L
authors.initials: L
authors.lastname: Cruz
authors.forename: F N
authors.initials: FN
authors.lastname: Peña Pimentel
authors.forename: L
authors.initials: L
authors.lastname: Perez
authors.forename: R
authors.initials: R
authors.lastname: España
mesh_terms: D000293:Adolescent; D000328:Adult; D000962:Antimalarials / Q000008:administration & dosage / Q000009:adverse effects; D037621:Artemisinins / Q000008:administration & dosage* / Q000009:adverse effects*; D000077332:Artesunate; D003967:Diarrhea / Q000139:chemically induced* / Q000453:epidemiology; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D015767:Mefloquine / Q000008:administration & dosage* / Q000009:adverse effects*; D008875:Middle Aged; D060735:Pharmacovigilance; D012189:Retrospective Studies; D014687:Venezuela / Q000453:epidemiology; D014839:Vomiting / Q000139:chemically induced* / Q000453:epidemiology; D055815:Young Adult
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D000077332:Artesunate; D015767:Mefloquine