Type II diabetes medications that contain saxagliptin can cause heart failure, especially in patients who have kidney or disease. Physicians who prescribe these medications negligently place their patients at risk for life-threatening consequences.
The Risks of Onglyza
Onglyza ( saxagliptin ) is a commonly prescribed medication for the management of Type II diabetes that is produced by AstraZeneca, and previously produced by Bristol-Meyers Squibb. Known as a DPP-4 Inhibitor, the medication assists in the retention of the hormone incretin to help patients maintain appropriate blood glucose levels.
Patients who take Onglyza are 27% more likely to suffer heart failure requiring hospitalization than patients who are not prescribed the medication. The risks increase with patient age. Studies from the American Heart Association have demonstrated that heart failure is a leading cause of death for diabetic patients over the age of 65. It’s estimated that approximately 68% of those with diabetes within this demographic die of heart disease which is roughly twice the rate of non-diabetic patients within the same age group.
FDA Guidelines and Approval
Noting the risk of heart failure in patients with Type II diabetes, the FDA updated their approval guidelines for anti-diabetic medications in 2008. The revision required manufacturers to prove their medications did not pose an unacceptable risk to patients. Onglyza was approved in 2009.
Citing concerns over the drug’s safety and efficacy, the 2013 “Savor Trial Study” demonstrated that while Onglyza does control ischemic function in patients, the drug poses a significant risk of heart failure. The study monitored just under 16,500 patients with Type II diabetes over a two year period. During the period, 3.5% of patients were admitted to hospitals for heart failure. The study concluded that other treatment methods should be utilized that do not place patients at risk. Further, the results of the study prompted the FDA Endocrinologic and Metabolic Drugs Advisory Committee to require new safety warnings on the drug that warn patients of the increased risk of heart failure.
Drug Company Liability
AstraZeneca along with Bristol-Myers Squibb acted slowly in updating their warnings and failed to adequately warn patients of the risks caused by using Onglyza. The negligence of these drug manufacturers can lead to permanent damage to the cardiovascular system. To date, these companies are facing more than 100 lawsuits for the pain and suffering, medical expenses, and wrongful deaths caused by the use of Onglyza.