Article date: May 2013
Although the Black Triangle (▼) has been in place in the UK for many years to signify medicines that are subject to intensive monitoring, it will now also be used in all EU countries and this list of medicines has been agreed Europe-wide. Throughout Europe, this scheme is known as ‘additional monitoring’.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of a medicine is important for continued monitoring of the balance of benefits and risks. The same monitoring methods are used across the EU so that information gathered in individual countries can be shared. This provides a wealth of knowledge for regulators and enables us to act quickly to protect public health, for example by providing warnings to healthcare professionals and patients, or restricting the way a medicine is used.
If a medicine carries a Black Triangle (▼), this means that it is subject to intensive monitoring. We are particularly interested in hearing about any suspected adverse reactions associated with these medicines. You can report online at www.mhra.gov.uk/yellowcard.
A Black Triangle will be assigned to a medicine if:
- it contains a new active substance; new medicines or vaccines authorised on or after January 2011 are assigned a Black Triangle
- it is a biological medicine (eg, a vaccine or a medicine derived from plasma)
- it has been given a ‘conditional approval’ (enabling medicines to reach patients with unmet medical needs earlier than might otherwise be the case while ensuring that additional data on a product are generated, submitted, assessed, and acted on)
- it is approved ‘under exceptional circumstances’ (where the company is unable to provide comprehensive data for safety and efficacy under normal conditions of use because, for example, the indication is so rare)
- the company that markets the medicine is required to carry out additional studies (eg, to obtain data on long-term use or a rare side effect seen in clinical trials)
The up-to-date list of Black Triangle medicines is published every month on the MHRA website.
Black Triangle symbol in product information
The Black Triangle symbol will continue to appear in the Summaries of Product Characteristics and in advertising for the relevant medicines.
For the first time in EU countries, the Black Triangle will start appearing in the Patient Information Leaflets of the relevant medicines from the autumn of 2013. It is important that if patients ask you about the Black Triangle symbol that you explain that any suspected side effects should be reported on a Yellow Card, and that they should speak to a healthcare provider if they have any concerns about a medicine. Furthermore, it is also important that patients, consumers, and carers understand that the Black Triangle does not indicate that the medicines are unsafe—the symbol is simply a way of helping to ensure that new safety information can be quickly identified, and they can help by reporting any side effects.
It is important to note that there may be a delay between the decision to add or remove a medicine from the Black Triangle list and the time when its updated product information (displaying the Black Triangle or not, respectively) comes into circulation. This is because it takes some time for the updated product information to gradually replace older stock already on the EU market.
Remember that up-to-date product information (SPCs and PILs) is available on the MHRA website or EMA website if holds a Europe-wide license. The Black Triangle symbol is also displayed next to relevant medicines in the British National Formulary, British National Formulary for Children, and in the Monthly Index of Medical Specialties (MIMS).
Article citation: Drug Safety Update May 2013 vol 6, issue 10: Y1.