FDA to investigate saxagliptin and association with Heart Failure- AstraZeneca

The FDA has requested data from AstraZeneca as part of its investigation a possible association between use of Onglyza for Type 2 Diabetes and Heart Failure. The FDA will review Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin/metformin) after a study published in the New England Journal of Medicine reported an increased rate of hospitalisation for heart failure with use of these two drugs.

See-"Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus"-Benjamin M. Scirica, M.D., M.P.H., Deepak L. Bhatt, M.D., M.P.H., Eugene Braunwald, M.D., P. Gabriel Steg, M.D., Jaime Davidson, M.D., Boaz Hirshberg, M.D., Peter Ohman, M.D., Robert Frederich, M.D., Ph.D., Stephen D. Wiviott, M.D., Elaine B. Hoffman, Ph.D., Matthew A. Cavender, M.D., M.P.H., Jacob A. Udell, M.D., M.P.H., Nihar R. Desai, M.D., M.P.H., Ofri Mosenzon, M.D., Darren K. McGuire, M.D., Kausik K. Ray, M.D., Lawrence A. Leiter, M.D., and Itamar Raz, M.D. for the SAVOR-TIMI 53 Steering Committee and InvestigatorsN Engl J Med 2013; 369:1317-1326 ,October 3, 2013 DOI: 10.1056/NEJMoa1307684