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Glossary of Terms

We know that many of the concepts used on this site can be difficult to understand. For that reason, we have provided you with a glossary to help you make sense of the terms used in Comparative Effectiveness Research. Every word that is defined in this glossary should appear highlighted throughout the Web site. When you come upon a highlighted term and would like to read the full definition, you can either click on the word to visit the glossary or roll your mouse over the word for a pop-up definition.

 

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Black Box Warning

Definition: An advisory from the U.S. Food and Drug Administration (FDA) that tells health care professionals and consumers that a drug might be very dangerous for some people. The FDA is the U.S. Government agency that regulates and monitors drugs and medical devices to make sure they are safe and effective.

Example: Here is an example of a Black Box Warning:
FDA Alert [4/11/2005]: Increased Mortality in Patients with Dementia-Related Psychosis
FDA has determined that patients with dementia-related psychosis treated with atypical (second generation) antipsychotic medications are at an increased risk of death compared to placebo. Based on currently available data, FDA has requested that the package insert for each atypical antipsychotic be revised to include a Black Box Warning describing this risk and noting that this drug is not approved for this indication.