Reporting : Black Triangle Drugs (Medicines Under Intensive Monitoring)
When a medicine is first licensed for use in clinical practice, the numbers of patients that have been exposed is generally relatively small, compared to the number that will eventually receive it. Relatively uncommon reactions may therefore not have been detected. It is primarily for this reason that the Yellow Card Scheme was set up. New medicines are marked in the British National Formulary (BNF) and all publicity material with a Black Triangle (). Special reporting advice also applies to these medicines and they are generally described as being intensively monitored products by the MHRA.
Therefore, all reactions (minor or serious) to any medicines with the Black Triangle symbol () against them in the BNF, MIMS, the Summaries of Product Characteristics in the Electronic Medicines Compendium should be reported.