FDA black box warnings take their name from the black border around the warning information. The information in the box must have a header in all caps and information printed in bold typeface. These warnings notify the public of serious, permanent or fatal side effects.
Boxed warnings first appeared on medications in the 1970s. While drug companies are responsible for creating the information on a drug label, only the FDA has the authority to issue a black box warning.
Once a drug receives a black box warning, its manufacturer must also create a medication guide that describes how patients can safely use the drug. These guides come with the medication at the pharmacy and are available online on the FDA website.
Black box warnings warn the public, but also alert doctors and other prescribers to serious side effects. Some evidence suggests, however, that these warnings may go unnoticed by doctors, putting patients at risk.
What Is A Black Box Warning?
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Last Updated: November 23, 2021 by drmoea
Boxed warnings first appeared on medications in the 1970s. While drug companies are responsible for creating the information on a drug label, only the FDA has the authority to issue a black box warning.
Once a drug receives a black box warning, its manufacturer must also create a medication guide that describes how patients can safely use the drug. These guides come with the medication at the pharmacy and are available online on the FDA website.
Black box warnings warn the public, but also alert doctors and other prescribers to serious side effects. Some evidence suggests, however, that these warnings may go unnoticed by doctors, putting patients at risk.
Source: https://www.drugwatch.com/fda/black-box-warnings/
Category: Blog Tags: black box warning, dangerous drugs, fda, substance misuse