Saxagliptin, the active ingredient in Onglyza and Kombiglyze XR, has been linked to an increased risk of heart failure.
Lawsuits accusing AstraZeneca and Bristol-Myers Squibb of concealing this potentially life-threatening side effect are already pending in courts throughout the United States. You may be able to take legal action of your own if you or a loved one were prescribed Onglyza or Kombiglyze XR to treat Type 2 diabetes and were subsequently diagnosed with heart failure, congestive heart failure, or other cardiac injury.
HOWEVER, YOU MUST ACT NOW TO ENSURE THAT YOU RIGHTS TO RECOVER COMPENSATION ARE PRESERVED!
The attorneys at Gilman Law LLP are committed to ensuring that the victims of dangerous drug side effects obtain the justice they deserve. Filing a Onglyza or Kombiglyze XR lawsuit may be the only way for you and your family to hold the drugs’ manufacturers accountable and recover compensation for the medical bills and other damages related to your injuries.
Onglyza and Kombiglyze XR
Saxagliptin controls Type 2 diabetes by stimulating the release of incretin hormones by the gut. In turn, these hormones stimulate the pancreas to release insulin, thus lowering blood glucose levels.
Onglyza, which contains only saxagliptin, was approved by the U.S. Food & Drug Administration (FDA) in 2009. Kombiglyze XR, which contains both saxagliptin and metformin, came to market the following year.
When the FDA approved Onglyza, it ordered AstraZeneca to conduct further research into its possible cardiovascular side effects. The company subsequently completed a 16,000-patient cardiovascular outcomes trial called SAVOR, the results of which were published in the New England Journal of Medicine.
FDA Heart Failure Warnings for Onglyza and Kombiglyze XR
The SAVOR clinical trial suggested that patients treated with saxagliptin were 27% more likely to be hospitalized with heart failure compared to those treated with a placebo. The study also found a significant increase in the rate of “all-cause mortality” among saxagliptin patients.
Following publication of these findings, an FDA advisory panel voted 14-to-1 add a heart failure warning to the Onglyza and Kombiglyze XR labels. One panel member voted to withdraw saxagliptin from the market entirely.
While there would be no Onglyza or Kombiglyze XR recall, the FDA did order that the labels be modified to warn of a possible heart failure risk in April 2016.
Patients taking Onglyza and Kombiglyze XR should contact their doctor right away if they develop signs and symptoms of heart failure such as:
- Unusual shortness of breath during daily activities
- Trouble breathing when lying down
- Tiredness, weakness, or fatigue
- Weight gain with swelling in the ankles, feet, legs, or stomach
Legal Help for Victims of Onglyza and Kombiglyze XR Side Effects
The attorneys at Gilman Law LLP are available now to provide free legal consultations to individuals who were diagnosed with heart failure after taking Onglyza or Kombiglyze XR. Our firm is also evaluating Onglyza and Kombiglyze XR lawsuits on behalf of individuals who lost a loved one to heart failure or related complications.
For a free, no-obligation review of your potential Onglyza or Kombiglyze XR lawsuit, please fill out our free consultation form or call us direct to speak with one of our attorneys at (888) 252-0048.