The legal battle between the two companies continues with Kombiglyze suing XR in a federal lawsuit. The settlement of this case could be what we’ve been waiting for, but it might not come soon enough.
In 2015, Kombiglyze XR or Onglyza were given to about 386,000 patients. However, data suggests that these common type 2 diabetes medications may increase the risk of cardiac problems in patients.
Kombiglyze XR (saxagliptin and metformin), a type 2 diabetes medicine, has been linked to heart failure and other cardiovascular problems in certain people, according to research.
30 million Americans have diabetes, and 84 million have pre-diabetes, according to the Centers for Disease Control and Prevention (CDC). Metformin, one of the medications in the combination drug Kombiglyze, is one of the top ten most often prescribed pharmaceuticals in the United States. According to analysts, sales of Kombiglyze’s sibling medicine, Onglyza (saxagliptin), might reach $1.8 billion in 2018.
According to the FDA, around 386,000 patients were given Onglyza or Kombiglyze XR in 2015. Given the large number of individuals who use these medications, any adverse effects that are serious enough to need hospitalization should be managed with caution.
Hundreds of patients are suing Kombiglyze’s producer, AstraZeneca, and its former partner, Bristol-Myers Squibb, saying that the corporations failed to sufficiently assess the drug’s safety before marketing it, resulting in their cardiovascular ailments.
Does Kombiglyze XR Increase the Risk of Heart Failure in Patients?
One of the first studies to identify cardiovascular health hazards related with these medicines was financed by AstraZeneca and Bristol-Myers Squibb.
Assessment of Vascular Outcomes with Saxagliptin Those with a history of heart issues who took Onglyza or Kombiglyze XR had a 27 percent higher likelihood of being hospitalized for heart failure than patients who took a placebo, according to the SAVOR study. Patients who had chronic renal disease and/or had previously had heart failure were more likely to be admitted to the hospital.
When the findings of the SAVOR research were examined by an FDA panel, 14 out of 15 panelists decided to require a safety warning on all Onglyza and Kombiglyze XR labels, stating that the medications might cause cardiovascular damage.
Are Injured Patients Bringing Lawsuits Against Kombiglyze XR?
According to plaintiffs’ lawyers, these claims are “simply the tip of the iceberg.”
Patients are suing AstraZeneca and Bristol-Myers Squibb, saying that Kombiglyze XR and Onglyza were to blame for their heart problems. AstraZeneca and Bristol-Myers Squibb are accused of failing to appropriately evaluate the medications before to their sale, according to the complaints.
More than 80 Onglyza and Kombiglyze XR lawsuits were centered in Lexington, Kentucky in February 2018. Since these lawsuits were “only the tip of the iceberg” and the number of filed complaints was projected to expand, plaintiffs’ lawyers claimed that centralization is critical to reduce discrepancies.
In a January 2018 lawsuit, Illinois plaintiff Jerald Adams claimed that after being exposed to saxagliptin while taking Onglyza and Kombiglyze XR, his heart failure diagnosis was “directly attributable to taking these medicines.”
Mr. Adams claimed in his lawsuit that the makers were aware of the danger of cardiovascular harm linked with saxagliptin, but failed to warn or minimize this risk despite their knowledge.
“Defendants had knowledge at all relevant times that saxagliptin was associated with a significantly increased risk of adverse events, 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 claims filed in New Jersey argue that Bristol-Myers Squibb and AstraZeneca not only failed to assess the safety of their medications, but also failed to undertake the clinical studies required by the FDA in 2008 prior to the launch of Onglyza in 2009.
“Concerns concerning cardiovascular risk should be more completely addressed during medication development,” the FDA Endocrinologic and Metabolic Drugs Advisory Committee said in 2008. After Bristol-Myers Squibb and AstraZeneca failed to accomplish so, Onglyza was launched in 2009.
What is the Purpose of Lawsuits?
In the Onglyza and Kombiglyze XR litigation, AstraZeneca and Bristol-Myers Squibb are accused of failing to:
- Warn the FDA, the medical community, and the general public of the potential cardiovascular dangers of these medications.
- Conduct sufficient pre-clinical and clinical testing to see whether the medications raised the risk of cardiovascular damage.
- Create the medications in such a way that specific side effects are minimized.
- Conduct thorough post-market surveillance of saxagliptin’s side effects.
Are You Entitled to File a Lawsuit?
Individuals who have had heart failure or other cardiovascular ailments, such as congestive heart failure or myocardial infarction, may be qualified to file a case against AstraZeneca and Bristol-Myers Squibb. Medical expenditures, lost earnings (past and future), pain and suffering, and other expenses may be covered by a lawsuit.
Michael Goetz, one of our attorneys, is a member of the plaintiffs steering committee for the incretin mimetics MDL in Southern California, which is suing the makers of Januvia, Janumet, Byetta, and Victoza. This family of type 2 diabetic medicines (sister pharmaceuticals to Kombiglyze XR and Onglyza) is accused of causing pancreatic issues in patients, according to these cases. Our lawyers contribute not just their knowledge to the Kombiglyze case, but also the breadth of our firm’s resources: over 370 attorneys in 40 locations.
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Frequently Asked Questions
What are the side effects of KOMBIGLYZE XR?
A: The side effects of KOMBIGLYZE XR include a sudden decrease in weight, temporary changes to vision, and an increased sensitivity to sound.
Is there a lawsuit against the makers of metformin?
A: No. There is no lawsuit against the makers of metformin. Metformin, or Glucophage as it was called in past years, has been around for over 10 decades and there have never been any lawsuits filed against its manufacturers
Is kombiglyze the same as metformin?
A: Kombiglyze is a medication that is used for diabetes, but metformin does not have any relation to diabetes.