The reason it's called a black box warning is because it gets it's name from the black border which the U.S. Food and Drug Administration or FDA requires around the text or warning on the medication labels and the package inserts which highlight the serious risks that are associated with the medication.
The black border also helps to allow the text to stand out so that you will read it.
The black box warning is mandated and the warnings are also mandated by the FDA that the warnings be placed in a prominent location and often at the top of the package insert, to ensure they are easily noticed by both patients and healthcare professionals.
The main purpose of the black box warning is to alert users, including doctors and patients to the potential serious or even life threatening adverse effects that are associated with a certain medication.
The black border, bold text as well as the prominent placement is all designed to draw attention to the warning and emphasize it's importance.
The black box warning was first implemented in 1979, and is the strictest labeling requirement that the FDA can mandate for prescription medications.
The meaning of a black box warning is a high safety related warning that the medications can have major risks.
The FDA assigns the high risk medications with the black box warning to warn users of the medications of the potential major risks and side effects from the drug.
Black Box warnings are now mostly known as boxed warnings.
MedWatch data is stored in the FDA Adverse Event Reporting System (FAERS).
The FDA then uses FAERS to track medication side effects and safety issues.
It helps the FDA look for patterns and changes in frequency or severity.
And upon investigation, they may determine that a specific risk needs a black box warning.
Some boxed warnings are for side effects that are rare and only happen with a frequency of 1 in 10,000 or 1 in 100,000.
The boxed warning in mental health is for increased risks of suicidal thoughts and behaviors in children and adolescents with major depressive disorder and other psychiatric conditions who take antidepressants.
A prominently displayed boxed warning, the so-called “black box,” is added to the labeling of drugs or drug products by the Food and Drug Administration when serious adverse reactions or special problems occur, particularly those that may lead to death or serious injury.