What is a black box warning? All you need to know…

by Staff writer

A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evidence of an association of a serious hazard with the drug.

Any drug having the black box warning means that an adverse reaction to the drug may lead to death or serious injury.

Here are common drugs we use that currently have a black box warning:

1. Gentamicin

2. Vitamin and iron supplements

3. Ibuprofen

4. Aspirin

5. Ketoconazole (antifungal)

6. Metronidazole (Flagyl)

7. Fentanyl, among others.

Please know that there is always a risk and benefit associated with taking any drug.

The black box warning is to alert prescribers of the potential risk in prescribing a particular drug so they can take it into consideration.

If you have concerns regarding any of your current prescriptions, discuss with your physician immediately.


Visit www.aafp.org to read more.

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