What Is The Black Box Warning?

The black box warning, or boxed warning, is FDA's strictest warning added to the labeling of any prescription drug. The warning is designed to call attention to significant risks or even life-threatening adverse effects.

A boxed warning is a warning with a black box around it, hence the name. In the absence of clinical data, the black box warning is based on clinical data or serious animal toxicity data. Prescription drugs with a black box warning have either shown or are expected to have a serious adverse event or death. The FDA requires the warning to be placed in the package insert so that practitioners can heed the warnings and monitor on a regular basis the patients who are on these medications.

A boxed warning is implemented in collaboration with the pharmaceutical company that produced the drug only after the FDA confirms the serious risk, and depending on the severity of adverse events. The warning does not mean the drug should not be used, it is just a means of communication from the FDA to prescribers to highlight the risk. If you have concerns regarding your prescription, discuss with your physician.

If you have been hurt by the use of dangerous prescription drugs, you will need an experienced and resourceful personal injury lawyer who can understand the problems with your medicinal regimen, determine the strength of your case, and define potentially liable parties. Our Miami-based law firm, The Law Offices of Sean M. Cleary has represented clients who have suffered medication-related injuries throughout the state of Florida. Call today 305.416.9805 to protect your right to a recovery before legal deadlines expire.