Morgan & Morgan has filed a lawsuit against the makers of the drug Kombiglyze XR because some of its users have allegedly suffered heart failure and/or death.
Kombiglyze XR (saxagliptin and metformin) belongs to a new class of diabetic drugs known as DPP-4 inhibitors. It is manufactured by AstraZeneca and FDA-approved for the treatment of Type 2 diabetes. It is the extended release version of the drug Onglyza (saxagliptin), which is intended to lower glucose levels and diabetic complications in adults with Type 2 diabetes.
In February 2014, the Food and Drug Administration (FDA) issued a Drug Safety Communication regarding Kombiglyze XR, having determined that some users may face an increased risk of congestive heart failure while taking the drug. As a result, a meeting of an FDA advisory committee recommended that Kombiglyze XR labeling be updated to warn against heart failure risk — a warning that was previously not included on the medication’s label.
If you or a loved one has suffered heart failure and/or death after taking Kombiglyze XR, you may be able to file a lawsuit against AstraZeneca and recover compensation. To learn more about your legal rights, contact Morgan & Morgan for a free case review.
Why Should Kombiglyze XR Users Be Concerned?
The FDA has determined that people with type 2 diabetes taking Kombiglyze XR may have an increased risk for heart failure and death overall.
The FDA came to its conclusion on Kombiglyze XR after reviewing a post-market study it ordered Astra Zanica to undertake after the drug was initially approved. The study included 16,000 people and sought to determine whether the drug increased a patients risk for a cardiovascular event such as heart attacks.
The study was published in 2013 in the New England Journal of Medicine (NEJM) and found that, compared to a placebo, saxagliptin resulted in a 27% increase in the rate of patient hospitalization for heart failure. The study also found that saxagliptin users had an increased risk of dying from non-cardiovascular causes, such as infection or hemorrhaging.
The FDA convened a meeting of its Endocrinologic and Metabolic Drugs Advisory Committee in April 2015 based on the NEJM study findings, to determine the heart failure risk of Kombiglyze XR. 14 of 15 committee panelists voted for an updated Kombiglyze XR label that warns about the risk of increased heart failure. One panel member voted to remove Kombiglyze XR from the U.S. market.
Why Didn’t Kombiglyze XR Label Originally Warn of Heart Failure?
In 2008, the FDA announced there would be new recommendation for evaluating the risks of new Type 2 diabetes drugs. Specifically, the FDA wanted companies to conduct “a more thorough examination of their drugs’ cardiovascular risks during the product’s development stage.”
With regard to Kombiglyze XR, it met the statistical criteria for cardiovascular events (such as heart attacks) outlined in the 2008 FDA Guidance, but the FDA still had questions about the adequacy of the pre-market studies used to meet this criteria and was not convinced of the drug’s cardiovascular safety.
AstraZeneca actually wanted to include a statement in Kombiglyze XR prescribing information that said saxagliptin may be associated with a reduced risk of cardiovascular events, but the FDA did not allow this based on its skepticism of the pre-market studies. This skepticism prompted the FDA to require AstraZeneca to perform a more stringent post-market study. The study performed to meet the new, more stringent FDA requirements was the aforementioned 2013 NEJM study, which found an increased risk of heart failure for Kombiglyze XR users.
There are major differences between the pre and post-market testing of Kombiglyze XR, which can explain why the original testing resulted in inconclusive cardiovascular findings. For example, in clinical trials, patients were tested for a median of 62 weeks (1.19 years), while the post-marketing study followed patients for a median of 2.1 years.
Rather than performing more comprehensive testing of Kombiglyze XR prior to FDA-approval, AstraZeneca waited until after the drug was approved to perform this testing. The result is that thousands of patients may have been unnecessarily exposed to heart failure and death risks.
Discuss Your Case For Free With a Morgan & Morgan Kombiglyze XR Attorney
Morgan & Morgan’s experienced personal injury legal team is speaking with Kombiglyze XR users who have suffered heart complications and are considering legal action against AstraZeneca. Learn how we may be able to protect your legal rights via a lawsuit during a free case review with one of our nationally-recognized personal injury class action attorneys.