What is the purpose of a "black box warning" on a package insert?

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A black box warning is about a drug the FDA has required a manufacturer to prominently display in a box in the package insert.The intent of the black box is to draw attention to the specific warning and make sure that both the prescriber and patient understand the serious safety concerns associated with that drug.A black box on an airplane is used to reconstruct events prior to a tragedy;however,the black box warning on a medication package insert is used to warn about safety concerns with the drug.A black box is not used as a warning about illicit use of medications.All drugs must go through preclinical and clinical trials prior to being marketed.

What Is the Purpose of a "Black Box Warning" on a Package