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
Black Triangle Drugs now include Dianette (cyproterone acetate & ethinylestradiol)and Champix (Verenicline) the drug prescribed to help smokers also known as Chantix.
“The Black Triangle”
Although
the Black Triangle has been used
since the 1980s in the UK to
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 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
4. Overview
5. Medicines
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.
