Kombiglyze XR Lawsuit
In 2015, roughly 386,000 people were prescribed Kombiglyze XR or Onglyza. But research shows these popular type 2 diabetes drugs may put patients at risk of heart complications.
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.
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.
Are Injured Patients Filing Kombiglyze XR Lawsuits?
These lawsuits are "just the tip of the iceberg," according to plaintiffs attorneys.
Patients are filing lawsuits against AstraZeneca and Bristol-Myers Squibb alleging that Kombiglyze XR and Onglyza caused their cardiovascular injuries. Complaints allege that AstraZeneca and Bristol-Myers Squibb failed to adequately test the drugs 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.
What Do Lawsuits Allege?
Specifically, Onglyza and Kombiglyze XR lawsuits allege that AstraZeneca and Bristol-Myers Squibb failed to:
- Warn the FDA, the medical community, and the general public of the cardiovascular risks associated with these drugs.
- Conduct adequate pre-clinical and clinical testing to determine if the drugs caused increased risks of cardiovascular injuries.
- Design the drugs so as to minimize certain adverse effects.
- Conduct adequate post-market monitoring of saxagliptin’s adverse events.
Are You Eligible for a Lawsuit?
Individuals who have suffered from heart failure or other cardiovascular injuries—such as congestive heart failure or myocardial infarction—may be eligible for a lawsuit against AstraZeneca and Bristol-Myers. A lawsuit may help recover compensation for medical bills, loss of wages (past and future), pain and suffering, and more.
Our attorney Michael Goetz currently serves on the plaintiffs steering committee for the incretin mimetics MDL in Southern California against manufacturers of Januvia, Janumet, Byetta, and Victoza. These lawsuits allege that this class of type 2 diabetes drugs (sister drugs of Kombiglyze XR and Onglyza) cause pancreatic problems in patients. Our attorneys not only bring this experience to the Kombiglyze litigation, but also the depth of resources our firm offers: more than 370 attorneys across 40 offices.
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