Boxed warning

It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of preventable, serious or even life-threatening adverse effects.

It is not necessarily true that a physician and patient will have a conversation about a drug's boxed warning after it is issued.

[4] For instance, an FDA-mandated boxed warning decreased rosiglitazone use by 70%, but that still meant 3.8 million people were given the drug.

[5] Boxed warnings on drugs have received increased media attention in the United States since 2004.

Among some of the more widely covered stories: In China, a warning text (警示语) may be added to a package insert, either voluntarily by the manufacturer or at the request of NMPA (formerly CFDA, the Chinese counterpart of FDA).

An exemplary boxed warning, as seen in context, in FDA's Challenges and Issues with Safety-Related Information in the Prescribing Information slide deck. For emphasis, the text is bolded and surrounded by a black outline.