The manufacturer of two popular diabetes drugs — Onglyza and Kombiglyze XR — is facing legal action after studies have revealed a link between these drugs and serious adverse events such as cardiac arrest and congestive heart failure. After suffering these adverse events, individuals have filed lawsuits alleging that AstraZeneca began marketing Onglyza before conducting clinical trials to determine the drug’s effect on cardiovascular health, contrary to guidance from the U.S. Food and Drug Administration (FDA).
Onglyza (saxagliptin) and Kombiglyze XR were approved by the FDA in 2009 and 2010, respectively, and are intended to help individuals with Type 2 diabetes control their blood sugar. However, a 2013 clinical study published in the New England Journal of Medicine found a link between saxagliptin and an increased risk of heart failure. The FDA began investigating this link and concluded in April 2016 that type 2 diabetes medications containing saxagliptin and alogliptin may increase a patients’ risk of heart failure. As a result, the FDA mandated new warning labels for these medications.
In the wake of the FDA’s mandated label change, around 80 lawsuits have been filed that allege serious injuries or death resulting from the use of Onglyza (saxagliptin) or Kombiglyze XR. Given the common legal and factual issues in these cases, these lawsuits were consolidated in February 2018 before a federal judge in Kentucky. To learn more about this litigation or to see whether you have a case against the manufacturer of Onglyza and Kombiglyze XR, contact our offices today.