For the first time, patients will start to see the black triangle (▼) in the patient information leaflet for relevant medicines. There will also be information on how to report suspected side effects via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).
In the UK, the black triangle (▼) has been in place for many years to aid the monitoring of new medicines through encouraging the reporting of suspected adverse reactions. The black triangle (▼) has now been adopted for use in Europe.
Accompanying text will explain that the symbol means that the medicine is being monitored particularly closely. This is generally because there is less information available about it compared with other medicines, eg because it is new to the market or there is limited data on its long-term use. This does not mean that the medicine is unsafe. A list of black triangle medicines can be found on the MHRA website: www.mhra.gov.uk/blacktriangle.
Find out more about the Black Triangle Scheme:
- Black Triangle Scheme – new medicines and vaccines subject to EU-wide additional monitoring
- Find out more about the Yellow Card Scheme
- Drug Safety Update May 2013 – Black Triangle (▼) medicines now part of an EU-wide scheme: remember to report any suspected adverse reactions
- European Medicines Agency publishes a video explaining the concept of medicines under additional monitoring