Onglyza is composed of the active ingredient Saxagliptin and Kombiglyze XR is a combination of Saxagliptin and Metformin. Both are DPP-4 inhibitors used to treat type two diabetes. Both drugs are manufactured by AstraZeneca, formerly Bristol-Myers
Squibb Company. Onglyza was approved in the U.S. on July 31, 2009 and Kombiglyze XR was approved for sale on November 5, 2010.
2. Heart Failure
In April 2014, an FDA Advisory Committee meeting occurred regarding cardiovascular safety concerns associated with Saxagliptin. The SAVOR study (Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus; can be found here:
https://www.nejm.org/doi/full/10.1056/NEJMoa1307684#t=article) revealed a statistically significant 27 percent increased risk of heart failure in those taking Saxagliptin. The shocking results of the SAVOR study prompted the FDA to request the raw data from the SAVOR study to allow the FDA to analyze the data free from
manipulation. Subsequently, the FDA Advisory Committee recommended that Saxagliptin drugs add a warning specific to heart failure on their label. On April 5, 2016, a warning specific to heart failure was added to Saxagliptin drug labels.
3. Multidistrict Litigation in Kentucky – MDL 2809
As of January 2018, approximately 85 lawsuits related to heart failure caused by Saxagliptin were pending around the country. Because the lawsuits shared common issues, on February 2, 2018, the Judicial Panel on Multidistrict Litigation ordered all cases against the manufacturers of Onglyza and Kombiglyze XR to be transferred to the
Eastern District of Kentucky, where Judge Karen K. Caldwell would preside over the coordinated pretrial proceedings. As of February 26, 2019, just one year later, over 230 cases are currently pending before Judge Caldwell in the MDL. On September 6, 2018, Judge Caldwell appointed Jennifer A. Moore of Moore Law Group, PLLC and Timothy Clark of Sanders Phillips Grossman, LLC as plaintiffs’ co-lead counsel in MDL 2809.
Have you been injured?
If you or someone you love suffered heart failure or congestive heart failure while taking Onglyza or Kombiglyze XR, contact the lawyers at Moore Law Group, PLLC at 502-717-4080 for a free, no-obligation evaluation of your potential case.