Call Us Today - It's Free!
Kombiglyze XR Lawsuit - morgan and morgan
Contact us today

Kombiglyze XR

Kombiglyze XR Lawsuit

five stars
1145 reviews
Contact us today
  • $15 Billion+ Won
  • 800+ Lawyers Nationwide
  • The Fee is FreeTM, Only Pay If We Win
  • America’s Largest Injury Law Firm
  • Protecting Families Since 1988
Kombiglyze XR

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.

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.

Free Case Evaluation

Tell us about your situation so we can get started fighting for you. We tailor each case to meet our clients' needs.


Kombiglyze XR Lawsuit FAQs

  • 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.

Hear From Our Clients

We’ve helped over 300,000 families across the United States. See what they have to say.

Video Thumbnail 51bcb06a38fd51350ab04f248c54649b
Car Accident
5 stars

Our Personal Injury Lawyers
Have Over 55,000
5-Star Google Logo Reviews

Krista M.
They were caring and concerned about my case. They fought harder then I had intercepted. Communicated in many ways to make sure I understood. Thank you.
Video Thumbnail c365385942fb26326e4995f6183d63aa
Workers' Compensation
Nancy H.
The staff was amazing, they treated me with the utmost respect and professionalism. Kept me informed every step of the way about my case. Always asked how I was doing and was prompt with responding to any of my questions or concerns. They are a great team!
Video Thumbnail 419e5af5085d2d39d047d1f86b8ab922
Premises Liability
Mike J.
Morgan and Morgan is truly the best law firm! PERIOD! You could consider yourself blessed when they take your case. Immediately, you can breathe. Anxiety goes from a 10 to 0! I needed them 3 TIMES! I wish I didn’t have to hire an attorney but my family and I were blessed. We won every single time! Insurance companies truly know that they will take it to court! I got settlements for all 3 lawsuits. Never stepped a foot into a courtroom. Thank you so much Morgan & Morgan!
Video Thumbnail e583ee5c147184b7fadd90d29428fd88
Home Insurance Claim
Kourtney W.
The entire Morgan & Morgan team, including my case manager Michelle Hill, have been a blessing! From the first phone call I made to them, they have been extremely compassionate, very helpful, and 100% professional. I would recommend Morgan & Morgan to anyone because THEY CARE!
Results may vary depending on your particular facts and legal circumstances.
See More

The Fee is FreeTM Only Pay If We Win.


Free case evaluation icon

Submit a Free Case Evaluation

You can find out if you qualify immediately.


Incoming icon

Get a Call From Us

Our specialists will walk you through your case and collect all the right information to win your case.


Woman with computer icon

Let Us Get to Work

Our specialized attorneys will handle every step of your case from start to finish. You don’t pay until we win.

Call Us Now

See Our Nationwide Results

We’ve won over $15 Billion for our clients in cases of all types. Let us work hard for you.

Car icon
Car Accident
Medical Malpractice icon
Medical Malpractice
Clock and money icon
Unpaid Overtime
Tobacco icon
Slip & Fall icon
Slip & Fall
Premises Liability icon
Premises Liability
Social Security icon
Social Security
Civil Rights icon
Civil Rights
Results may vary depending on your particular facts and legal circumstances.
Last updated on May 11, 2023

How Can We Help You Today?

Free Case Evaluation

Tell us about your situation so we can get started fighting for you. We tailor each case to meet our clients' needs.