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Boxed Warning

Boxed warning

In USA drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information. This is often referred to as a “boxed” or “black box” warning. Drugs that have such boxed warnings are not permitted to have reminder ads.

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 adverse effects.


About Piotr Wrzosiński

Piotr Wrzosinski is a sociologist focused on digital marketing in highly regulated industries. He combines experience from top players in tobacco, financial services, and pharma with a passion to the content marketing and technology. All opinions posted are his own unless stated otherwise.
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