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Castle Law Office

What Is a Black Box Warning and Why Would Drugs Need One?


A black box warning, named for the black border surrounding the text of the warning, is the most serious warning by the U.S. Food and Drug Administration (FDA) a medication can carry and still remain on the market in the United States. It indicates that a drug has serious side effects or life-threatening risks.

The FDA requires a black box warning for the following situations:

  • The medication can cause fatal, life-threatening, or permanently disabling adverse reaction compared to the potential benefit from the drug.
  • A serious adverse reaction can be prevented, reduced in frequency, or reduced in severity by proper use of the drug.

The FDA requires the boxed warning to provide a concise summary of the adverse side effects and risks associated with taking the medication.

Along with a black box warning, the FDA also requires a drug company to create a medication guide that contains information for consumers on how to use the medication safely. The guides contain FDA-approved information that can help you avoid a serious adverse event.

If you're concerned your medication has a black box warning, ask your pharmacist and your doctor about potential risks.

The black box warning is sometimes considered enough of a safety precaution that it protects the manufacturer from liability, but not always. If you've been seriously injured by a medication you should contact our office as soon as possible. Call us today at 816-842-7100 to speak with an attorney that will fight to get you the compensation you deserve. Or you can click here to email us and schedule your free consultation. 

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