Black Box Warnings
Black Box Warnings
Black Box Warnings (pronunciation: /blæk bɒks wɔːrnɪŋs/), also known as boxed warnings, are the strictest warnings by the U.S. Food and Drug Administration (FDA) about the potential risks associated with certain prescription drugs and medical devices.
Etymology
The term "Black Box Warning" comes from the black border that typically surrounds the text of the warning. The FDA first introduced these warnings in 1997 to alert healthcare professionals and patients to serious and life-threatening risks associated with a drug or device.
Definition
A Black Box Warning is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening effects.
Related Terms
- Adverse Drug Reaction: An unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use and suspected to be related to the drug.
- Drug Safety: The pharmacological science ensuring safety and related issues such as side effects of drugs.
- Pharmacovigilance: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Examples
Some drugs that carry Black Box Warnings include antidepressants, antipsychotics, and certain types of painkillers. These warnings alert healthcare professionals and patients to the potential risks of using these drugs, and they are often a factor in a healthcare professional's decision to prescribe a particular drug.
Importance
Black Box Warnings play a crucial role in ensuring drug safety. They provide valuable information about the potential risks and benefits of a drug, helping healthcare professionals and patients make informed decisions about treatment options.
External links
- Medical encyclopedia article on Black Box Warnings
- Wikipedia's article - Black Box Warnings
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