Boxed warnings – an explanatory note from the Australian Therapeutic Goods Administration

“A boxed warning provides a succinct warning statement, and draws the attention of the prescriber to more detailed information within the main body of the PI. Details of the data sources for the safety issue (e.g. clinical trials, adverse events or precautions) would not routinely be placed in the boxed warning. The wording of the boxed warning need not be identical to the text of the main body of the PI. Usually, the content of the boxed warning summarises or is drawn from PI text.” Read more about the significance and utility of boxed warnings from the recent statement issued by the TGA