Friday, 5 September 2014
BLACK TRIANGLE DRUGS under High Scrutiny
Black Triangle classification on drugs your doctor may prescribe should be carefully monitored and ANY suspected adverse reactions reported to www.yellowcard.gov.uk a pharmacovigilance system we have to support as it is the only 'official' one. Please also report to the web site monitored by doctors https://www.rxisk.org as they may take more active efforts to create awareness of newly discovered adverse drug reactions (ADRs) also please report all psychiatric ADRs to any medicine or following anaesthetics to APRIL www.april.org.uk
Although the Black Triangle has been used since the 1980s in the
indicate that a drug is under intensive surveillance, new pharmacovigilance
legislation in Europe now extends the Black
Triangle symbol across the EU.
The Black Triangle will have to be present in the manufacturer’s Summary of Product Characteristics (SPC) and associated packaging patient leaflet (PIL) of any product subject to additional monitoring, along with the phrase “This medicinal product is subject to additional monitoring”.
Further information about all drugs available in the
are on the web site www.medicines.org.uk this is the Association of British Pharmaceutical
Industries (APBI) electronic medicines compendium and has masses of good
information. The SPC contains more information as it contains data the
manufacture must submit when the drug is first licensed and should be updated
as adverse reactions not originally listed are discovered. UK
Additional monitoring under the Black Triangle scheme applies to:
§ all medicinal products with a new active substance
§ biological medicinal products, including biosimilars
§ Any other medicine a regulator can demonstrate a specific requirement for additional monitoring
Black Triangle status will normally last for 5 years, but can be extended if ongoing safety issues require it.
Please report ALL suspected adverse drug reactions to any drug which has a black triangle symbol next to it to www.yellowcard.gov.uk and APRIL will appreciate information about psychiatric adverse reactions to add to our data, used to promote action and improve education for health professionals.
Black Triangle drugs in the EU full list: go to the complicated MHRA web site www.mhra.gov.uk and be patient ! click on
1. Safety Information,
2. MEDICINES (in left menu)
3. How we monitor the safety of products
6. Black Triangle Medicines then right at the bottom of the page you will find a link to the latest list of drugs designated with the Black Triangle
If MHRA web site changes cause problems just put Black Triangle in search box at www.mhra.gov.uk Unfortunately my attempts to provide a direct link to the information are unsuccessful. I have written to the MHRA to suggest the Black Triangle information should be on the home page or found with just one click.