What type of medication may require a "Black Box" warning?

A "Black Box" warning is the most serious type of warning that the Food and Drug Administration (FDA) can issue for prescription medications. It is required for drugs that carry a significant risk of serious or even life-threatening side effects. The purpose of the black box warning is to highlight these risks so that healthcare providers and patients can make informed decisions when considering treatment options.

Medications that are associated with potentially severe adverse effects—such as certain antidepressants, anti-seizure medications, or medications used for chronic conditions—often carry this warning. This label serves as a critical tool in informing users about the potential dangers while also focusing attention on the importance of monitoring and understanding the risks involved. Understanding the presence of such warnings is vital for both healthcare providers when prescribing and patients when assessing their medication options.