Engelsk titel: What happens with an adverse drug reaction report when it reaches the European Medicines
Agency?
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Författare:
Svendsen, Kristian
Språk: Nor
Antal referenser: 24
Dokumenttyp:
Översikt
UI-nummer: 16043594
Sammanfattning
This article looks at what happens in Europe to an adverse drug reaction (ADR) report has been submitted in Norway. It also looks at how ADR reports contribute to safer medicines.
ADR reports are being forwarded from the Norwegian Medicines Agency (NoMA) to the European Medicines Agency (EMA). At EMA the reports contribute in a monitoring process in which new signals of ADRs are detected, confirmed, evaluated and where possible outcomes of this process include a change of the label (SmPC) or a further evaluation of the benefit-risk balance of the drug.
In 2013 around 2500 signals were detected by EMA, out of these about 20 led to a change in the labelling. Two examples where ADR reports have contributed are bromhexine and the risk of serious cutaneous adverse reactions and aripiprazole and the risk of aggression and hyperprolactinaemia.