Onglyza and Kombiglyze may increase the risk of heart failure
We are helping patients and families. If you or a loved one experienced any serious side effects from your use of Onglyza or Kombiglyze, you may want to consider your potential legal claim to help with medical bills, wage loss, and other losses. Call us at 1.800.887.8029, or fill out our Onglyza free case review form and we can help you navigate the next steps.
FDA Safety Alert
The FDA announced a safety alert on April 5, 2016 that certain type 2 medications, such as Onglyza and Kombiglyze, may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. The FDA’s Safety Communication advised doctors to consider stopping the use of Onglyza and Kombiglyze in patients who develop heart failure. Reports indicate that AstraZeneca, the company that makes and sells Onglyza and Kombiglyze, has known about the connection between the diabetes drugs and heart failure since as early as 2013.
In 2013, The New England Journal of Medicine (NEJM) published the SAVOR Trial. SAVOR found that people who used saxagliptin (e.g., Onglyza or Kombiglyze) had an increased rate of hospitalization for heart failure compared to people who took a placebo. The trial evaluated 16,492 patients from 788 sites in 26 countries, making it arguably one of the largest trials of its kind.
Let us help you navigate the next steps. To learn more about the SAVOR study and the legal options for people who may have experienced an injury while taking Onglyza and Kombiglyze, fill out our free case review form on the right and a member of our Drug Safety Team will contact you and walk you through your options in the legal process.
FDA Requires AstraZeneca to warn patients of increased risk of heart failure
On April 5, 2016, the FDA required AstraZeneca to change the Onglyza and Kombiglyze labels to warn patients that taking the diabetes drugs may increase the risk of heart failure. Prior to this recent label change, patients taking Onglyza or Kombiglyze were not warned that taking the diabetes drugs might increase their risk of heart failure, even though AstraZeneca knew about the increased risks as early as 2013. The Onglyza label now includes the following warning:
In a cardiovascular outcomes trial enrolling participants with established ASCVD or multiple risk factors for ASCVD (SAVOR trial), more patients randomized to ONGLYZA (289/8280, 3.5%) were hospitalized for heart failure compared to patients randomized to placebo (228/8212, 2.8%). In a time-to-first-event analysis the risk of hospitalization for heart failure was higher in the ONGLYZA group (estimated Hazard Ratio: 1.27; 95% CI: 1.07, 1.51). Subjects with a prior history of heart failure and subjects with renal impairment had a higher risk for hospitalization for heart failure, irrespective of treatment assignment.
How We Can Help
For more information, or if you would just like to talk a member of our drug safety team, please call us toll-free at 1.800.887.8029 for a free consultation or fill out an online free case review form. Zimmerman Reed is experienced in handling defective prescription drug cases and we welcome any questions you may have.