Drug-induced arrhythmias, quantifying the problem

Abstract

Cardiac arrhythmias as an adverse reaction to the use of non-antiarrhythmic drugs have attracted much attention during recent years. It has become the single most common reason for regulatory action regarding the marketing of drugs. Although drug-induced arrhythmias are very rare (approximately 1 per 10,000 to 100,000), they are of regulatory concern. This is mainly because they can be fatal, their occurrence is somewhat unpredictable and many patients use these potentially harmful drugs. The aim of the research presented in this thesis was to quantify the risk of drug-induced arrhythmias and identify high-risk groups of patients. Furthermore, methodological aspects and validity issues of epidemiological research on rare adverse reactions, such as drug-induced arrhythmias, were also addressed. The findings presented in this thesis may be used to improve future research, but above all they may improve the quality of patient care and hopefully save lives.