Continued monitoring of medicines with a black triangle status.
Article date: June 2009
Report ALL suspected adverse reactions to Black Triangle drugs.
When medicines come onto the market, we may have relatively limited information about their safety from clinical trials. These trials generally involve only relatively small numbers of patients who take the medicine for a relatively short time and will identify only the more common adverse effects of treatment. Only when large numbers of patients have taken a medicine are rare or long latency adverse effects identified. Therefore, effective surveillance after marketing is essential for the identification of rare adverse effects, and to ensure that appropriate action is taken.
New medicines are intensively monitored to ensure that any new safety hazards are identified promptly. The Commission on Human Medicines (CHM) and the MHRA encourages the reporting of all suspected reactions to newer drugs and vaccines, which are denoted by an inverted Black Triangle symbol (▼). This symbol appears next to the name of a relevant product in:
- a drug safety update
- the British National Formulary (BNF) and the Nurse Prescribers’ Formulary (NPF)
- monthly index of medical specialities (MIMS)
- the electronic medicines compendium
- advertising material
A Black Triangle symbol is assigned to any drug or vaccine if it meets any of the criteria which is:
- a new active substance or a biosimilar medicine
- a new combination of medicines or active substances
- a new route of administration
- a new drug-delivery system
- an established medicine which is to be used in a new patient population
All similar biological medicines (biosimilars) have a Black Triangle symbol because although any such product has been developed to be similar to an existing biological product, it may not have an identical structure and thereby requires intensive monitoring of safety and efficacy.
Some well-established products may have the Black Triangle symbol reinstated— for instance if the product has been approved for use in a significantly new indication or in a new population. These products are denoted by an asterisk next to the Black Triangle (▼). For example, the Black Triangle symbol has been reinstated for Cozaar▼ (losartan), specifically for the new indication of heart failure. Furthermore, Cancidas▼* (caspofungin) has had a Black Triangle reinstated after it was approved for use in children.
The MHRA assesses the Black Triangle status of a product usually 2 years after marketing; however, there is no standard time for a product to retain Black Triangle status. The symbol is not removed until the safety of the drug is well established.
The CHM and the MHRA continue to monitor intensively all products with a Black Triangle symbol (▼). Healthcare professionals are asked to report all suspected adverse drug reactions to these products through the Yellow Card Scheme. The symbol ▼* highlights the importance of reporting suspected adverse reactions that are related to the reason for reinstating the Black Triangle to the drug (eg, use in a new indication or new patient population). Such reporting helps us to:
- confirm the benefit/risk profile that was established during clinical development
- ensure that we identify previously unrecognised side effects as quickly as possible
For Black Triangle enquiries, please email firstname.lastname@example.org
Article citation: Drug Safety Update June 2009, vol 2 issue 11: 7.