The European Medicines Agency has published the initial list of medicines that are subject to additional monitoring, representing an important deliverable of the new European pharmacovigilance legislation.
These medicines will have to display an inverted back triangle in their package leaflet and in the information for healthcare professionals called the summary of product characteristics (SmPC), together with a short sentence explaining what the triangle means. If a medicine is labeled with the inverted black triangle, it does not mean that it is unsafe; the purpose of the symbol is to actively encourage healthcare professionals and patients to report any suspected adverse reactions observed with the medicine, either because the medicine is new to the market or because there is a limitation to the data available on its safety.
Reporting suspected adverse reactions helps gather more information on medicines on the market. Regulatory authorities look at reports of adverse reactions, 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 to optimize safe and effective use.
Medicines that are subject to additional monitoring are:
A medicine can be included on this list when it is approved for the first time or at any time during its lifecycle. It remains under additional monitoring for five years or until the PRAC decides to remove it from the list usually because studies have further established the safety profile of the product concerned. Other medicines can also be placed under additional monitoring, based on a recommendation from the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).
Marketing-authorization holders of medicines on the list are required to update the product information to include the new black symbol and explanatory text using the latest version of the product-information templates. They should start to include new information in the product information during the course of 2013.
An implementation plan outlines the exact regulatory process and timeline the companies need to follow to comply with these new requirements. The complete additional-monitoring list will be reviewed every month by the PRAC and published on the Agency's website, where additional information on additional monitoring can also be found in all EU languages.
The inverted black triangle will start appearing in the package leaflet and SmPC of the medicines concerned from the autumn of 2013.