Skip to main content

Table 1 main characteristics of 35 cases of fatal outcome from cardiac origin presumably related to halofantrine

From: Fatal cardiotoxicity related to halofantrine: a review based on a worldwide safety data base

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

 

â—¦ 1 dose: n = 1 (3%)

 

â—¦ 2 doses: n = 9 (26%)

 

â—¦ 3 doses: n = 10 (28%)

 

â—¦ other including pediatric formulation: n = 3

 

   • second course of halofantrine: n = 6

 

â—¦ 5 or 6 doses: n = 5 (14%)

 

â—¦ 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

  1. missing data: a: n = 3; b: n = 2; c: 6; d: n = 7