New Pharmacovigilance Information on an Old Drug An International Study of Spontaneous Reports on Digoxin

Summary Suspected adverse drug reactions for digoxin from Australia, France, Ger­ many, Sweden, the UK and the US, which were reported to the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring since 1968, were examined for qualitative and quantitative differences between countries. Intercontinental Medical Statistics (IMS) data on drug utilisation and demographic information were used to explain a much higher reporting of sus­ pected reactions from Australia and a later peak of occurrence with age in France. Australia has a greater number of elderly patient visits to doctors resulting in a prescription, but it is unclear whether this is due to a greater number of patients taking digoxin or to more frequent prescriptions. In France, doctors used higher doses of digoxin in the over 80 years age group than in other countries, which may account for more dose-related effects.