Research shows that type 2 diabetes drug Kombiglyze XR (saxagliptin and metformin) may cause heart failure or other cardiovascular injuries in some patients.
According to the Centers for Disease Control and Prevention (CDC), 30 million Americans have diabetes and 84 million have pre-diabetes. Metformin—one of the drugs found in combination drug Kombiglyze—is among the top 10 most popular prescription drugs taken by Americans. Analysts also predict that Onglyza (saxagliptin), Kombiglyze’s sister drug, could reach $1.8 billion in sales in 2018.
In 2015, roughly 386,000 people were prescribed Onglyza or Kombiglyze XR, the FDA reported. Given that so many people take these drugs, any side effects they may cause that are severe enough to hospitalize patients should be treated with concern.
Dozens of patients are filing lawsuits against Kombiglyze’s manufacturer AstraZeneca and its previous partner Bristol-Myers Squibb alleging that the companies failed to adequately test the drugs’ safety prior to selling it, which ultimately caused their cardiovascular injuries.
If you or a loved one took Kombiglyze XR as directed and suffered from Kombiglyze XR side effects including heart failure or other cardiovascular injuries—such as congestive heart failure or myocardial infarction, after starting Kombiglyze XR therapy, contact Kombiglyze XR lawyer Timothy L. Miles today to see if you are eligible for a Kombiglyze lawsuit and possibly entitled to substantial compensation.
Read on for answers to frequently asked questions about a Kombiglyze XR Lawsuit.
What Is Kombiglyze?
Kombiglyze XR is a combination of metformin (a biguanide) and saxagliptin (a DPP4 inhibitor). Kombiglyze XR works by lowering the amount of sugar made by your liver, decreasing the amount of sugar absorbed by your intestine, increasing the amount of insulin your body makes, and helps your body respond better to insulin.
Kombiglyze XR comes in tablet for in dosages of 5mg/500mg, 2.5mg/1000mg and 5mg/100mg. The starting dose depends on what medications you are currently taking for diabetes, and depending on how you respond, your doctor will adjust your dose. The maximum dose for Kombiglyze XR is 5 mg/2000 mg( saxagliptin/metformin) by mouth once daily with dinner.
What Are the Kombiglyze XR Side Effects?
The following are some of the common Kombiglyze XR side effects:
Additionally, dozens of lawsuits allege other Kombiglyze XR side effects including serious cardiovascular injury. If you suffered Kombiglyze XR side effects including cardiovascular injuries, contact Kombiglyze XR lawyer Timothy L. Miles today for a free case evaluation.
What Is the Problem with Kombiglyze XR?
Research shows Kombiglyze XR and other similar drugs may put patients at risk of heart complications. Dozens of patients are filing lawsuits against Kombiglyze’s manufacturer AstraZeneca and its previous partner Bristol-Myers Squibb alleging that the companies failed to adequately test the drugs’ safety prior to selling it, which ultimately caused their cardiovascular injuries.
Does Kombiglyze XR Put Patients at Risk of Heart Failure?
A clinical trial funded by AstraZeneca and Bristol-Myers Squibb was one of the first studies to report cardiovascular health risks associated with these drugs.
Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus, or the SAVOR trial, found that patients with a history of heart problems who took Onglyza or Kombiglyze XR had a 27% greater chance of being hospitalized for heart failure than patients who took a placebo. Patients with chronic kidney disease and / or previous heart failure were more likely to be hospitalized.
When an FDA panel reviewed the results from the SAVOR study, 14 out of 15 panelists voted to require a safety warning on all Onglyza and Kombiglyze XR bottles that the drugs could result in cardiovascular injury.
What Is the Status of the Kombiglyze XR Lawsuits?
Patients are filing lawsuits against AstraZeneca and Bristol-Myers Squibb alleging that Kombiglyze XR caused their cardiovascular injuries. Complaints allege that AstraZeneca and Bristol-Myers Squibb failed to adequately test the drug prior to their sale.
In February 2018, more than 80 Onglyza and Kombiglyze XR lawsuits were centralized in Lexington, Kentucky. Plaintiffs' attorneys said that centralization is key to reducing inconsistencies since these lawsuits were "just the tip of the iceberg" and the number of filed complaints was expected to grow.
In a complaint filed in January 2018, Illinois plaintiff Jerald Adams alleged that after being exposed to saxagliptin after taking both Onglyza and Kombiglyze XR, the diagnosis of his heart failure was “directly related to taking these drugs.”
In the complaint, Mr. Adams alleged that the manufacturers not only knew of the cardiovascular injury risk associated with saxagliptin, but that they also failed to warn or mitigate this risk despite their knowledge.
“At all relevant times, defendants had knowledge that there was a significantly increased risk of adverse events associated with saxagliptin, including heart failure, congestive heart failure, cardiac failure, and death related to those events, and despite this knowledge, defendants continued to manufacture, market, distribute, sell, and profit from sales of saxagliptin,” the complaint alleges.
Some lawsuits filed in New Jersey claim that Bristol-Myers and AstraZeneca didn’t just do a poor job of testing the safety of their drugs, but that they also didn’t conduct the clinical trials recommended by the FDA in 2008 prior to Onglyza’s sale debut in 2009.
In 2008, the FDA Endocrinologic and Metabolic Drugs Advisory Committee “determined that concerns about cardiovascular risk should be more thoroughly addressed during drug development.” Bristol-Myers and AstraZeneca failed to do so, and began marketing Onglyza in 2009.
How Do I Know if I am Eligible for a Kombiglyze XR lawsuit Lawsuit?
If you or a loved one took Kombiglyze XR as directed and suffered from heart failure or other cardiovascular injuries—such as congestive heart failure or myocardial infarction, after starting Kombiglyze XR therapy, you may meet the requirements for a Kombiglyze XR lawsuit and possibly be entitled to substantial compensation. Call a Kombiglyze XR lawyer for free today who can tell you if you are eligible for a Kombiglyze XR lawsuit.
Call a Kombiglyze XR Lawyer Today ?
If you or a loved one took Kombiglyze XR as directed and suffered from Kombiglyze XR Side Effects, specifically: heart failure or other cardiovascular injuries—such as congestive heart failure or myocardial infarction, after starting Kombiglyze XR therapy, contact Kombiglyze XR lawyer Timothy L. Miles today to see if you are eligible for a Kombiglyze XR lawsuit and possibly entitled to substantial compensation.
Timothy L. Miles is a nationally recognized shareholder rights attorney raised in Nashville, Tennessee. Mr. Miles was recently selected by Martindale-Hubbell® and ALM as a 2022 Top Ranked Lawyer, 2022 Top Rated Litigator. and a 2022 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. Please visit our website.
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