Tighe Wilhelmy with Velawcity here to discuss the recent consolidation of Onglyza® and Kombiglyze XR® claims by the JPML. The MDL was approved on February 2nd and will be overseen by Judge Karen K. Caldwell in the eastern district of Kentucky.
Onglyza® and Kombiglyze® XR are both Type II diabetic prescription drugs. They are manufactured by industry giant, AstraZeneca®, and were released July 31st, 2009 and November 5th, 2010 respectively. Combined revenues generated for these drugs exceeds (1) billion dollars per year in the United States.
Currently, thousands of claimants allege various cardiovascular injuries were experienced as a result of taking these diabetic drugs. These injuries currently include, but may not be limited to, Heart Failure, Congestive Heart Failure, Cardiac Failure, and Death.
On April 14th, 2015 an FDA Advisory Committee Meeting concluded with a (14-1) recommendation to the FDA that Onglyza® and Kombiglyze® XR add warnings for heart failure. It should be noted the (1) opposing vote believed a warning was insufficient and the drugs should be withdrawn from the market.
These recommendations came as a result of the Saxagliptin Assessment of Vascular Outcomes Recorded study, also known as SAVOR study, which found a 27% increased risk of heart failure. SAVOR ultimately reported that 3.5% of Saxagliptin patients suffered their first recorded Heart Failure event and roughly 26% of these subjects deceased. On April 5th, 2016 heart failure warnings were added to Onglyza® and Kombiglyze’s® drug labels.
Hopefully you enjoyed this mass tort update. For more information regarding Onglyza®, including case acquisition, please contact us at (480) 508-0219.