A black box warning is not always very serious and means that the drug may cause potentially severe side effects or interactions.
Some of the side effects or interactions that can be severe are usually pretty rare.
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.