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).