Adverse reactions to drugs and vaccine are common and may be serious, with the risk of leading to hospital admission, delayed discharge from hospital or death. It has been estimated that up to two-thirds of the ADRs may be preventable, or interrupted before they become severe.
The European Medicines Agency has introduced a new EU-wide scheme to improve reporting and prevention of new, unexpected and serious adverse reactions to drugs and vaccines. The scheme involves increased monitoring, including supported by a list of products identified by an inverted black triangle symbol: typically for products that are new, or have had a new indication or formulation approved, or for which serious concerns have been raised.
Communication materials on additional monitoring and the inverted black triangle symbol have been produced in all EU languages. For further details see the factsheet and video below and the EMA Press Release.