The FDA requested clinical trial data from the manufacturer of saxagliptin (marketed as Onglyza and Kombiglyze XR) to investigate a possible association between use of the type 2 diabetes drug and heart failure. The request resulted from a study published in the New England Journal of Medicine (NEJM), which reported an increased rate of hospitalization for heart failure with use of saxagliptin compared to an inactive treatment. The study did not find increased rates of death or other major cardiovascular risks, including heart attack or stroke, in patients who received saxagliptin. The manufacturer is expected to submit the trial data to the FDA by early March 2014, after which the FDA will conduct a thorough analysis and report its findings publicly.
At this time, the FDA considers information from the NEJM study to be preliminary. The FDA’s analysis of the saxagliptin clinical trial data is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk. Patients should not stop taking saxagliptin and should speak with their health care professionals about any questions or concerns. Health care professionals should continue to follow the prescribing recommendations on the drug labels.
Type 2 diabetes is a disease in which there is a high level of sugar, or glucose, in the blood because the body does not make or properly use the hormone insulin. If left untreated, type 2 diabetes can lead to serious problems. Saxagliptin is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. It works by increasing the amount of insulin produced by the body after meals, when blood sugar is high.
See the FDA Safety Announcement
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication