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

patient age^{a} (year)
| Median: 27; range: 2 - 53 |
---|---|

sex^{b}
| 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 patients^{c}
| • 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 |

species^{d}
| • 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 |