Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin) belong to a new class of diabetic drugs known as DPP-4 inhibitors. Onglyza gained federal drug approval by the U.S. Food & Drug Administration (FDA) despite initial concerns over the cardiovascular safety of the drug. These concerns were echoed in a post-marketing safety study that found Onglyza may be associated with an increased risk of heart failure and an increased risk of death. If you or a loved one took Onglyza as directed and suffered from Onglyza Side Effects, specifically: heart failure, death or another serious cardiovascular injury —such as congestive heart failure or myocardial infarction, after starting Onglyza therapy, contact Onglyza lawyer Timothy L. Miles today to see if you are eligible for a Onglyza lawsuit and possibly entitled to substantial compensation. Read on for the answers to five frequently asked questions about an Onglyza lawsuit. WHAT IS ONGLYZA?Onglyza (saxagliptin) is an add-on medication to diet and exercise to improve blood sugar control in people with type 2 diabetes. It is a is a dipeptidyl peptidase-4 (DPP-4) inhibitor that increases the amount of insulin your body makes. Onglyza comes in tablets in dosages of 2.5 mg and 5 mg taken once by mouth daily. WHO SHOULD NOT TAKE ONGLYZA?You should not take Onglyza if you are allergic to any of its ingredients. Serious allergic reactions can occur with Onglyza including swelling of the face, throat, lips and difficulty breathing, among others. Your doctor should test your blood to measure how well your kidneys work before and during treatment with Onglyza. You may need a lower dose of Onglyza if your kidneys are not working well. WHAT IS THE PROBLEM WITH ONGLYZA?Type 2 diabetes patients have a significantly increased risk of cardiovascular complications, and the majority of diabetics die from such complications. Amid growing concerns over the safety of many diabetes drugs, in 2008 the FDA recommended that the makers of new type 2 diabetes drugs provide evidence that the drugs do not increase the risk of cardiovascular events such as heart attacks. Onglyza met the FDA's cardiovascular safety criteria. Though the FDA approved the new diabetic drug, it had reservations about the sufficiency of Onglyza clinical trials and ordered AstraZeneca to perform a post-marketing study. As a result, AstraZeneca completed a 16,000-patient cardiovascular outcomes trial called SAVOR. The results of that trial were published in the New England Journal of Medicine and raised major Onglyza safety concerns. SAVOR found that Onglyza patients were 27% more likely to be hospitalized for heart failure. The study also found a significant increase in the rate of “all-cause mortality” among Onglyza patients. The warning signs of heart failure include:
Following the release of SAVOR, the FDA issued an Onglyza drug safety communication and convened an advisory committee meeting to analyze the results and recommend further action. The committee voted 14-to-1 to add information to Onglyza’s label warning about heart failure risks. The other member voted to withdraw Onglyza from the U.S. market. The committee, however, did not advise updating the warning label to address the measured increase in all-cause mortality among Onglyza patients and did not recommend any restrictions on prescribing the drug. In an April 2016 drug safety communication, the FDA announced that Onglyza and Kombiglyze XR are now required to carry warnings about heart failure risk. Other FDA warnings about saxagliptin include:
WHAT ARE THE ONGLYZA SIDE EFFECTS?In addition to heart failure, Onglyza is linked to these adverse side effects:
HOW DO I KNOW IF I MEET THE REQUIREMENTS FOR AN ONGLYZA LAWSUIT?If you or a loved one took Onglyza as directed and suffered suffered Onglyza side effects; specifically, heart failure, death, or another serious cardiovascular injury, after starting Onglyza therapy, you may meet the requirements for an Onglyza lawsuit and possibly be entitled to substantial compensation. Call a Onglyza lawyer for free today who can tell you if you are eligible for an Onglyza lawsuit. CONTACT AN ONGLYZA LAWYER TO SEE IF YOU ARE ELIGIBLE FOR AN ONGLYZA LAWSUIT?If you or a loved one took Onglyza as directed and suffered from Onglyza Side Effects, specifically: heart failure, death or another serious cardiovascular injury —such as congestive heart failure or myocardial infarction, after starting Onglyza therapy, contact Onglyza lawyer Timothy L. Miles today to see if you are eligible for a Onglyza lawsuit and possibly entitled to substantial compensation. TIMOTHY L. MILES, ESQ. Timothy L. Miles is a nationally recognized shareholder and consumer rights attorney raised in Nashville, Tennessee. Mr. Miles was recently selected by Martindale-Hubbell® and ALM as a 2023 Top Ranked Lawyer, 2023 Top Rated Litigator. and a 2023 Elite Lawyer of the South. Mr. Miles also maintains the AV Preeminent Rating by Martindale-Hubbell®, their highest rating for both legal ability and ethics. Mr. Miles is a member of the prestigious Top 100 Civil Plaintiff Trial Lawyers: The National Trial Lawyers Association, a superb rated attorney by Avvo, a recipient of the Lifetime Achievement Award by Premier Lawyers of America (2019) and recognized as a Distinguished Lawyer, Recognizing Excellence in Securities Law, by Lawyers of Distinction (2019). Mr. Miles has published over sixty articles on various issues of the law, including class actions, whistleblower cases, products liability, and more. Comments are closed.
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