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FDA Approves Jardiance for CV Mortality Indication

FDA news release; 2016 Dec 2

The FDA has approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular (CV) death in adult patients with type 2 diabetes mellitus and cardiovascular disease (CVD).

Indications: Jardiance is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated 1) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 2) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Dosage and administration: Recommended dose is 10 mg once daily, taken in the morning, with or without food. Dose may be increased to 25 mg once daily. Assess renal function before initiating. Do not initiate if eGFR is below 45 mL/min/1.73 m2.

Adverse reactions: The most common adverse reactions associated with Jardiance (5% or greater incidence) were urinary tract infections and female genital mycotic infections.

Citation:

US Food and Drug Administration. FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes. FDA web site. December 2, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm531517.htm. Accessed December 4, 2016.