What is the Origin of FDA Boxed Warning?

The concept of the Boxed Warning originated from the FDA's regulatory authority to ensure drug safety and proper use, formalized in response to significant safety issues identified post-market or during late-stage clinical trials. The distinctive black border surrounding the text is designed to ensure the information is immediately noticeable and cannot be overlooked by healthcare professionals. It is mandated under federal regulations to protect the public.

What is the Mechanism of FDA Boxed Warning?

The FDA mandates the inclusion of a Boxed Warning when there is evidence of a serious hazard, the risk can be prevented or reduced by specific actions, or the drug has been associated with an adverse reaction that is unusual in its frequency or severity. This regulatory action does not prohibit the drug's use but dictates that the serious risks be prominently disclosed, guiding clinical decisions and patient counseling regarding the drug's administration and potential complications.

FDA Boxed Warning ∞ Area

FDA Boxed Warning

Meaning

An FDA Boxed Warning, also known as a Black Box Warning, represents the strongest warning the Food and Drug Administration (FDA) requires to be placed on the labeling of prescription drug products. This warning alerts prescribers and patients to serious adverse reactions, such as significant safety risks, that may lead to death or serious injury. It is a critical communication tool for drugs, including certain hormonal therapies, where the benefits must be carefully weighed against potentially severe risks.