On April 5, 2016, the Federal Drug Administration issued new warnings concerning diabetes medications containing Saxagliptin and Alogliptin. The drugs at issue include Onglyza, Kombiglyze XR, Nesina, Kazano, and Oseni. All of these drugs are recommended for use, with diet and exercise, to lower blood sugar in adults with type 2 diabetes.
According to the FDA, in two large clinical trials, the FDA recommended that “health care professionals should consider discontinuing medications containing Saxagliptin and Alogliptin in patients who develop heart failure and monitor their diabetes control. If a patient’s blood sugar level is not well controlled with their current treatment, other diabetes medicines may be required.”
The FDA further recommended that patients taking these medications should “contact their health care professionals right away if they develop signs and symptoms of heart failure such as: unusual shortness of breath during daily activities, trouble breathing when lying down, tiredness, weakness, or fatigue, or weight gain with swelling in the ankles, feet, legs or stomach.” However, the FDA further notes that “patients should not stop taking their medicine without first talking to their health care professionals.”
Beyond the warnings by the FDA, in a 2013 article appearing in The New England Journal of Medicine, the authors studied 16,492 diabetic patients, 8,200 of which were taking Saxagliptin and 8,200 who were not taking the medication. According to The New England Journal of Medicine article, the patients on the Saxagliptin were at an increased risk for heart failure, as a result of the drug.
For more information on this and other adverse event reporting, you should go to www.fda.gov/MedWatch/report.