The Black Triangle Scheme

Some side effects, or adverse events from medicines are not known until the medicine has been in general use for some time. 

The Black Triangle Scheme identifies new prescription medicines with a black triangle on the medicine information documents. The scheme also applies to prescription medicines being used in new ways, such as a medicine that is now being used for children.  The Black Triangle is a visual reminder to encourage health practitioners and patients to report a problem or side effect. 

The scheme began at the start of 2018 in Australia. A similar Black Triangle Scheme operates in the European Union and the United Kingdom.

Image: This is the Black Triangle you will see on medicine information documents for newer medicines.

Why we use the Black Triangle

The Black Triangle does not mean that we know of any safety problems with a medicine. It means that the medicine is new or being used in a new way. We encourage people to report any adverse events for these new medicines to help us build a medicine's safety profile over time.

Despite extensive research and testing before a medicine is first available, it’s not possible to identify every possible side effect. When a medicine or vaccine is first registered and available in Australia, information about its safety and efficacy is only available from clinical trials.

We also use clinical trial information to support widened use of a medicine into different diseases, conditions or patient groups. Clinical trials generally have strict rules about who is included and a limited number of participants.

This means it’s common for new adverse events to be identified after people use new medicines more widely. New adverse events or side effects can also occur when existing medicines are used in a significantly different way, like:

• adult medicine used for a new patient group like children
• a diabetes medicine used for a new disease like heart failure.

Many adverse events are minor, but some can be serious and even life-threatening. Some adverse events are so rare that thousands of people can use a medicine for a long time before they are identified.

How the Black Triangle Scheme works

The Black Triangle reminds health professionals and consumers to report suspected adverse events related to new medicines, or those being used in new ways. Products included in the scheme feature the Black Triangle symbol and accompanying text on:

• Product Information (PI) documents
• Consumer Medicine Information (CMI) documents
• other TGA material and literature such as Australian Public Assessment Reports for prescription medicines (AusPARs).

Products included in the Black Triangle Scheme

The scheme applies to new Prescription medicines or to existing medicines we approve for new purposes or in new groups of people. The scheme may also apply to a new generic medicine where the original medicine is currently included in the scheme.  We include medicines in the scheme for at least 5 years. The 5-year period starts from the date of first supply.

You can find medicines included in the Black Triangle Scheme in the Australian Register of Therapeutic Goods (ARTG).

Reporting adverse events

Adverse events include any unfavourable and unintended sign, symptom or disease associated with the use of a medicine. Health practitioners and patients should report these events, especially:

• any serious adverse events
• those not listed in the PI and CMI.

Every report counts. All reports build a picture of the safety profile of a product and help with our safety monitoring program. Each adverse event report goes into a database. TGA staff analyse the data to identify emerging problems we may need to investigate.

We use this database of reports to monitor medicine safety after a medicine goes into public use or into the open market. This post market monitoring of the safety of medicines and vaccines is important. Our ongoing monitoring provides knowledge of possible adverse events when people start to use medicines outside the controlled conditions of clinical trials.