The FDA has approved an oral tablet formulation of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy) for chronic weight management in adults. It is the first oral GLP-1 receptor agonist to be approved in the US for weight management. An injectable formulation of Wegovy was approved for the same indication in 2021.1 The injectable GLP-1 receptor agonist liraglutide (Saxenda, and generic) and the injectable glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist tirzepatide (Zepbound) are also FDA-approved for chronic weight management (see
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RELEASE
The FDA has requested the removal of the suicidal behavior and ideation warning from the labels of the three glucagon-like peptide-1 (GLP-1) receptor agonists approved for chronic weight management: liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Zepbound). The warning was initially included in the labels of these drugs based on an increased risk of suicidal behavior and ideation observed with older drugs for weight management.1
Liraglutide, semaglutide, and tirzepatide are also marketed under different brand names for other indications, including treatment of type 2 diabetes, but the suicidality warning is not included in these labels.2 Removal of the warning was based on the results of analyses conducted by the FDA. In a meta-analysis of 91 controlled trials that included 107,901 patients, use of a GLP-1 receptor agonist was not associated with an increased risk of suicidal …