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What Is The FDA’s Black Box Warning?


The U.S. Food and Drug Administration approves, reviews, and filters what is safely available for public consumption. It is the agency’s job to protect public health by ensuring consumers are not unknowingly exposed to dangerous or defective products or medications. The FDA issues a “black box” warning label on prescription drugs presumed to lead to serious injury or death. Any medication with this warning on the label is proven or expected to risk various adverse health effects.  

The FDA works in collaboration with the pharmaceutical company to conduct extensive medical studies before assigning a black box warning. This is based on post-market evaluations which ensure the product’s usability. When there is sufficient evidence to signify this medication as dangerous, the FDA must confirm and highlight the associated risks.

However, a black box label does not mean a product is illegal or should not be consumed. Many of these drugs are still effective when appropriately administered to the people who need them. Patients consuming these medications must be under strict and regular monitoring from a physician to prevent any hazardous consequences. While the right medication can vastly improve your quality of life, misuse can result in a fatal outcome.  

Injured & Seeking Trusted Legal Advocacy in Kansas City? Contact Us

If you or a loved one has suffered as a result of a defective drug or product, you can rest assured you are not alone. Our tenacious and dedicated legal team at Bertram & Graf, L.L.C. is ready and willing to take on even the most intimidating adversaries. We will treat you and your case with the attention to detail and dedication necessary to deliver the results you deserve.

Allow us to fight for your rights. Call (888) 398-2277 today.