Black Box Warning Resources

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The strongest warning that the FDA requires is that of the Black Box Warning. This warning is reserved for prescription drugs that pose a significant risk of serious or life-threatening adverse effects, based on medical studies. The Black Box Warning is included in the labeling or medical information of the prescription drug.

Topical Resources

Black Box Warnings, powered by Formweb, provides a list of medications with black box warnings, alphabetically and by therapeutic class. This is a proprietary Web site and requires payment of a fee for access.

FDA Drug Safety Web site allows you to search or browse medications with FDA Safety Alerts; Healthcare Professional, Patient, and Consumer Information Sheets; Medication Guides; and Information Pages.

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