Onglyza, Kombiglyze XR
Heart Failure, Pancreatic Cancer
Lawsuits allege that diabetic drugs Onglyza or Kombiglyze XR (generic: saxagliptin and saxagliptin/metformin) are linked to:
- congestive heart failure,
- heart attack,
- myocardial infarction,
- cardiovascular injury.
- pancreatitis, and
- pancreatic cancer
All cases are consolidated in two courts:
- The Eastern District of Kentucky before the Honorable Karen Caldwell in MDL 2809: ONGLYZA (SAXAGLIPTIN) AND KOMBIGLYZE XR Judicial Panel(over 210 cases pending); and
- State Superior Court before Judge Curtis E.A. Karnow for for California residents claiming Onglyza caused heart failure. The consolidated California cases are: Case No. CJC-16-004909.
History of Warnings
Approved by the FDA in 2009 and 2010, heart failure issues were highlighted when a panel of FDA advisors recommended that the drug manufacturers, Bristol-Myers Squibb and AstraZeneca, update the product label to include the potential risk of heart failure. This warning was based upon dangerous results from a clinical trial entitled, SAVOR-TIMI 53 clinical trial (Saxagliptin Assessment of Vascular Outcomes Recorded in patients with Diabetes Mellitus) This controversial trial study was published in the New England Journal of Medicine. The clinical trial, SAVOR-TMI, showed close to a 30 percent increase in hospitalizations due to heart failure or other cardiac events and an overall higher risk of death for participants taking the diabetic drugs.
Finally, six years later in 2016, the FDA ordered Bristol-Myers Squibb and AstraZeneca to modify the “Warnings and Precautions” labels. Healthcare professionals should counsel patients regarding symptoms of heart failure and observe patients for signs and symptoms of heart failure, including:
- Swollen ankles, feet, legs, or stomach
- Feeling tired, weak, or fatigued
- Shortness of breath
- Difficult breathing when lying down
If you have suffered heart failure or pancreatitis or pancreatic cancer after taking Onglyza or Kombiglyze XR, contact us for a free medical legal consultation. You may be entitled to compensation for injuries you have sustained.