A black triangle drug is a drug that is new to the market and is being very intensively monitored and even more so than other medicines.
The black triangle drug being monitored more closely is because there is less information that is available on the medicine than other medicines.
The black triangle symbol identifies newly licensed medicines that require additional monitoring by the European Medicines Agency.
Such medicines include new active substances, biosimilar medicines, and medicines that the European Medicines Agency consider require additional monitoring.
The black triangle drugs most often carry the black triangle for at least 2 years.
The Drug Use Triangle shows how the effects and potential harms of drug use rely on the combination of three factors – The Person, The Drug and The Environment.
Before adding a boxed warning to a medication or medical device, the FDA must have evidence that the drug poses a significant risk.
This evidence comes from observations and studies conducted after a drug has been on the market.
For example, several kinds of combination birth control pills carry a black box warning related to cardiovascular risks associated with them.
The warning also strongly advises that women who use them not smoke, as cigarette smoking is known to increase the risk of those side effects.