Black triangle (pharmacovigilance)

The black triangle (▼), sometimes referred to as an inverted black triangle, is a symbol used in many countries, particularly within the European Union and countries aligned with its pharmacovigilance system, to indicate that a medicine is subject to additional monitoring. This means the medicine is being watched more intensively than other medicines.

The use of the black triangle signifies that the national medicines regulatory authority and the European Medicines Agency (EMA) consider that more information is needed about the medicine than is normally required. This doesn't necessarily mean that the medicine is unsafe. It simply signifies that active and ongoing monitoring of the medicine is crucial.

Medicines may be placed under additional monitoring for various reasons, including:

• The medicine contains a new active substance.
• It is a biological medicine, such as a vaccine or a medicine derived from human blood or plasma.
• There is limited experience with the medicine in long-term use.
• There is limited experience with the medicine when used in certain populations, such as children or the elderly.
• Studies show that there is a higher rate of reported side effects than expected.
• The medicine has been granted conditional approval or approval under exceptional circumstances.

When a medicine is under additional monitoring, this is indicated in the Summary of Product Characteristics (SmPC) for healthcare professionals and in the package leaflet for patients. The symbol (▼) is displayed prominently in these materials, along with a statement explaining its meaning and encouraging patients to report any suspected side effects.

The purpose of the black triangle scheme is to actively encourage the reporting of suspected adverse drug reactions (ADRs). By reporting any side effects, patients and healthcare professionals contribute to the ongoing safety monitoring of medicines and help to identify any new or changing safety concerns. This increased surveillance helps ensure that the benefit-risk balance of the medicine remains favorable for patients.