Table 1.
main characteristics of 35 cases of fatal outcome from cardiac origin presumably related to halofantrine
patient agea (year) | Median: 27; range: 2 - 53 |
---|---|
sexb | male: n = 9 (27%); female: n = 24 (70%) |
geographic origin of patients | developing world, n = 25; developed world, n = 10 |
type of report | • spontaneous n = 34 |
• clinical trial n = 0 | |
(GSK data base only) | • post marketing survey n = 0 |
source of report | health care professional n = 35 |
time from first dose to death (day) | median: 1; range: 0 3 |
• same day as first dose: n = 13 (37%) | |
• 1 day after first dose: n = 13 (37%) | |
• 2 days after first dose: n = 2 (6%) | |
• 3 days after first dose: n = 3 (8%) | |
• unknown: n = 4 (11%) | |
number of patients receiving 1 or 2 courses of halofantrive and number of doses taken by patientsc | • first course of halofantrine: n = 23 |
◦ 1 dose: n = 1 (3%) | |
◦ 2 doses: n = 9 (26%) | |
◦ 3 doses: n = 10 (28%) | |
◦ other including pediatric formulation: n = 3 | |
• second course of halofantrine: n = 6 | |
◦ 5 or 6 doses: n = 5 (14%) | |
◦ 8 doses: n = 1 (3%) | |
malaria diagnosis and malaria | • no diagnostic test performed: n = 8 |
speciesd | • blood smear negative: n = 7 |
• P. falciparum: n = 8 | |
• P. vivax: n = 1 | |
• Plasmodium sp: n = 4 | |
concomitant drugs with possible cardiac effect | n = 20 (57%) |
• anti-malarial: chloroquine: n = 7; mefloquine: n = 4; amodiaquine: n = 1; | |
• antibiotics: cyclines, n = 2; metronidazole, n = 1; ciprofloxacine, n = 1; norfloxacine, n = 1 | |
• drugs leading to electrolyte imbalance: diuretics, n = 2; potassium, n = 1 | |
underlying medical condition | n = 14 (40%) |
• cardiovascular disease, n = 11 | |
• obesity, n = 1 | |
• epilepsy, n = 1 | |
• severe anaemia, n = 1 |
missing data: a: n = 3; b: n = 2; c: 6; d: n = 7