Modern methods of pharmacovigilance: detecting adverse effects of drugs.

Medicines improve health and the chances of survival in a wide variety of conditions. At the same time, no substance with pharmacological effects is without hazard. Adverse drug reactions (ADRs) can be associated with the intended pharmacological effect of the medicine (eg bleeding from warfarin), mediated by other mechanisms (eg anticholinergic effects of tricyclic antidepressants) or can be altogether unexpected (eg hypersensitivity reactions to abacavir). Some ADRs can be identified early in the development of a medicine, but knowledge of the adverse effects profile is provisional when the medicine is first marketed and usually changes over time. Premarketing clinical trials include too few patients and are too short to detect every outcome that will affect public health and individual patient safety. In addition, clinical trials are carried out in controlled settings that differ from real-world practice. This reduces their power to detect ADRs, for example those that are due to drug-drug interactions or that affect only susceptible subgroups (eg phocomelia due to thalidomide). Safety needs to be evaluated continuously throughout the life-cycle of a medicinal product.1,2 A key challenge is to identify emerging problems as early as possible, without generating false alarms.

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