Black box warning

Black box warning (also known as a boxed warning or black label warning) is a type of warning that appears on the package insert for certain prescription drugs, as well as on the labeling of the prescription drug itself. The warning is designed to call attention to serious or life-threatening risks that may be associated with the drug.

Overview

The Food and Drug Administration (FDA) requires a black box warning for drugs that have specific serious or life-threatening risks. The warning is named for the black border that typically surrounds the text of the warning. The FDA first began requiring black box warnings in 1979.

Purpose

The purpose of a black box warning is to alert healthcare professionals and patients to the potential risks associated with a particular drug. The warning is intended to be a clear and concise summary of the most important information about the risks of the drug.

Criteria for a Black Box Warning

The FDA may require a black box warning if a drug is associated with serious or life-threatening risks. The decision to require a black box warning is based on a variety of factors, including the severity of the risk, the likelihood of the risk occurring, and the population at risk.

Impact on Prescribing Practices

The presence of a black box warning can influence prescribing practices. Some healthcare professionals may choose to prescribe a different drug that does not carry a black box warning, particularly if there are comparable alternatives available. However, in some cases, the benefits of a drug may outweigh the risks, even if the drug carries a black box warning.

Controversies

There have been controversies surrounding the use of black box warnings. Some critics argue that the warnings can be overly alarming and may deter patients from taking necessary medications. Others argue that the warnings are not prominent enough and that more should be done to ensure that patients are fully informed of the risks.

See Also

• Food and Drug Administration
• Prescription drug
• Drug safety