Deciphering the FDA’s black box warning | Bart Durham Injury Law

Deciphering the FDA’s black box warning

Unfortunately, taking just about any medication is not without risk. People in Tennessee who are either taking over-the-counter or prescription drugs should be aware of possible side effects. A study published with the National Institutes of Health reports that 33 percent of medication mistakes can be attributed to confusion regarding the drug’s packaging and labeling.

Fortunately, the U.S. Food and Drug Administration regulates medications and provides a system to call attention to potential threats. The FDA uses a black box warning system to let consumers know when there is a serious and even life-threatening risk associated with an adverse reaction to that specific drug. This information can be found in the prescribing information and is the most serious warning that the FDA gives. reports that the use of black box warnings has increased over the last 10 years. More often than not, a black box warning is added to a drug after the FDA has approved it, though there have been instances in which the administration requires the warning at the time of approval. Once the administration begins receiving reports of adverse events, it can launch an investigation and determine whether or not the black box is warranted.

A drug manufacturer that is required to include a black box warning must also provide a guide so consumers know how to safely take a medication. The pharmacist will give the guide to patients, and the FDA will also have the guide available online. When a drug does not have an adequate warning, consumers in Tennessee and across the country do have the right to hold a negligent manufacturer responsible.


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