Black Box Warnings

Black Box Warnings are the strictest safety warnings issued by the FDA for prescription drugs. They are displayed prominently on a drug’s label and inform healthcare providers and patients about serious or potentially life-threatening side effects associated with the medication. These warnings help ensure that the benefits of the drug outweigh the risks when used appropriately. They may also include guidance on how to minimize potential harm. Essentially, Black Box Warnings serve as an important safety alert to promote careful use and informed decision-making regarding the medication.