Application of the Bradford Hill Criteria to Assess the Causality of Cisapride-Induced Arrhythmia

Abstract

This study showed how different types of evidence found in pharmacovigilance can be evaluated using the Bradford Hill criteria. Further work is required to examine how the criteria can be applied to different types of adverse events and how they may be applied to pharmacovigilance.

The evolution of evidence hierarchies: what can Bradford Hill's ‘guidelines for causation’ contribute?

“…We use the term 'guidelines' over the more common 'criteria' [16][17][18][19][20][21] because Bradford Hill did not regard any of the guidelines as necessary or sufficient for establishing causation 11 : '. none of these viewpoints can bring indisptuable evidence for or against a cause{and{effect hypothesis and equally none can be required as a sine qua non'.…”

Managing gastro-oesophageal reflux in infants

“…1 However, it has been withdrawn from the market in most countries, including the UK, because it prolongs the QTc interval, increasing the likelihood of sudden death. 45 Domperidone and metoclopramide are dopamine receptor antagonists that have been used to treat GORD, but neither is licensed for this use in infants and both can cause acute dystonic reactions. 1 30 Furthermore, an association between domperidone and prolongation of QTc interval in infants has been reported, 46 and metoclopramide has caused tardive dyskinesia.…”

Managing gastro-oesophageal reflux in infants

“…Cisapride is an example of a motility stimulant that was widely used for infant GOR;1 however, it has been withdrawn from the market in most countries, including the UK, because it prolongs the QTc interval, increasing the likelihood of sudden death 45. Domperidone and metoclopramide are dopamine receptor antagonists that have been used for GORD, but neither is licensed for this indication in infants and both can cause acute dystonic reactions 1 , 30.…”