What are Black Box Warnings?

Posted By Regan Zambri Long, PLLC || 2-Jan-2018

The Food and Drug Administration (FDA) occasionally requires a “black box warning” for a prescription drug or medical device. These are the most serious warnings required for FDA-approved products. If the FDA has determined a product has a risk of serious injury or death, it may require its manufacturer to include a black box warning on the labeling.

A black box warning will summarize adverse reactions you may experience while using a product. For instance, the black box warning on Cymbalta, a drug used to treat anxiety and depression, warns of a heightened risk of suicide for children, adolescents and young adults with major depression or other psychiatric disorders. Amphetamine-based drugs, which are used to treat ADHD, have black box warnings because they may cause cardiac events or sudden death.

Black box warnings are only issued after a product has been FDA-approved. The FDA receives numerous adverse event reports and complaints from consumers before it investigates whether a product deserves this warning. Therefore, you may not always receive advanced notice if you are taking a dangerous drug or using a defective medical device. Pharmaceutical companies may also hide defects from the FDA while they are seeking approval for their products.

Could I File a Defective Drug or Medical Device Lawsuit?

There are cases where individuals file lawsuits after they or loved ones are harmed by FDA-approved products with black box warnings. Depending on the type of product, corrective surgeries or other procedures may be needed. Individuals affected by dangerous drugs or defective medical devices may suffer from physical and psychological pain. Damages from a lawsuit could help pay for the expenses caused by these problems.

The Washington DC defective medical device lawyers at Regan Zambri Long PLLC could review your situation to help you determine whether you have options to pursue damages against a drug or medical device manufacturer.

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