Black box warnings have become an integral part of medication safety since their introduction in 1979. These warnings, mandated by the U.S. Food and Drug Administration (FDA), serve as the most serious labeling requirement for prescription drugs. They are designed to highlight potentially life-threatening adverse reactions or severe safety concerns that healthcare providers and patients need to be aware of when considering the use of a particular medication. The implementation of a black box warning is a result of thorough data review, including clinical trials, post-marketing surveillance, and adverse event reports. When a significant safety concern is identified, the FDA collaborates with the drug manufacturer to develop appropriate warning language. This warning is then prominently displayed at the beginning of the package insert, enclosed in a black border, and printed in bold type to ensure it captures the attention of healthcare providers and patients.