New drugs and vaccines under intensive surveillance

Black triangle symbol

This section provides information about reporting suspected adverse drug reactions for healthcare professionals. Information for patients is available in the 'Patient reporting of suspected adverse drug reactions' section (please see 'Related information on the right of this page').

What are black triangle drugs?
When new medicines enter the market after clinical trials, we have relatively limited information about their safety. New medicines are therefore intensively monitored, by the Commission on Human Medicines (CHM) and the MHRA in order to confirm their risk/benefit profile, and are assigned an inverted black triangle symbol to indicate this. The CHM and MHRA encourages the reporting of all suspected reactions to black triangle drugs and vaccines.

The black triangle symbol is displayed against all relevant products in:

  • in the 'British National Formulary' (BNF)
  • in the 'British National Formulary for Children' (BNFC)
  • in the 'Nurse Prescribers' Formulary' (NPF)
  • in 'MIMS'
  • in the 'ABPI Medicines Compendium'
  • on advertising material.

Why is it a black triangle product?
A black triangle is assigned to a product if the drug is a new active substance which has been newly licensed for use in the UK. However, a product containing previously licensed active substances may also be monitored and assigned black triangle status if it meets one or more of the following criteria:

  • it contains a new combination of active substances
  • administration of the drug via a new route of administration or drug delivery system
  • a significant new indication which may alter the established risk/benefit profile of that drug.

There is no standard time for a product to retain black triangle status, however, an assessment is usually made following two years of post-marketing experience. The black triangle symbol is not removed until the safety of the drug is well established.

Why do we monitor black triangle drugs?
We wish to receive all reports of suspected adverse reactions associated with black triangle products, in order to:

  • confirm risk/benefit profiles established during the pre-marketing phase
  • increase our understanding of the safety profiles of new medicines
  • ensure that we identify previously unrecognised side effects as quickly as possible.

Clinical trials generally involve small numbers of patients who take a medicine for a relatively short period of time, and there are strict conditions for the inclusion of patients in such trials. This means that the patients in whom the medicines are tested during the trials may not be fully representative of the patients who will use the medicine when it is marketed. In addition, it is not until large numbers of patients have taken a drug that we can detect side effects which are rare or which appear after long-term use. Close monitoring of new medicines once they are being more widely used in the general population enables us to identify such side effects and take appropriate action.

As well as requesting reports on all black triangle products, the MHRA encourages the reporting of all serious suspected reactions to established drugs and vaccines, even if the effect is well known.

For specific black triangle enquiries please contact us at blacktriangle@mhra.gsi.gov.uk

Current drugs under intensive surveillance (Black Triangle List)
Drugs under intensive surveillance (Black Triangle List): Generic names - January 2010PDF file (opens in new window) (265Kb)
Drugs under intensive surveillance (Black Triangle List): Trade names - January 2010PDF file (opens in new window) (266Kb)

Previous drugs under intensive surveillance (Black Triangle List)


Page last modified: 13 January 2010