EMA initiative on reporting side effects of medicines

The European Medicines Agency (EMA) has launched a survey to better understand patients’ and healthcare professionals’ awareness of reporting adverse drug reactions, including for medicines under ‘additional monitoring.’

The EMA notes that medicines under additional monitoring are monitored particularly closely by regulatory authorities. They are easily identified by a black inverted triangle displayed in their package leaflet and in the information for healthcare professionals, called the ‘summary of product characteristics’ (SmPC). Healthcare professionals and patients are encouraged to report any suspected adverse reactions.

Regulatory authorities continuously look at reports of side effects alongside all the information they already have to make sure that the benefits of medicines remain greater than their risks and to take any necessary action.