Saxagliptin, a new generation of diabetes drugs, entered the market in 2009 under the name Onglyza. The following year, Kombiglyze XR combined Saxagliptin with metformin for a similar effect. Both fall under the drug class known as dipeptidyl peptidase-4 inhibitors, or simply DPP-4, a group of medications designed to lower blood sugar levels in adults living with Type 2 diabetes.
What makes them different from other diabetes drugs? When adults use it in conjunction with improved diet and exercise habits, it assists with pancreatic insulin creation and reduces the amount of glucose the liver produces and, as another benefit, prevents the user from gaining weight. As a result, doctors have prescribed these two medications 1.7 million times per year, and its sales are expected to reach $2.74 billion by 2018.
Yet, while the drug shouldn’t be given to adults already living with diabetic ketoacidosis, it comes with several severe side effects: Long-term joint pain, pancreatic cancer, and increased risk of heart failure. For the latter of these three, patients who went onto experience congestive heart failure or other cardiac symptoms after taking Saxagliptin allege manufacturers AstraZeneca Pharmaceuticals and Bristol-Myers Squibb never alerted physicians about these risks and played them down on their warning labels.
Studies & Warnings
In 2008, after multiple complaints about adverse cardiovascular events, the FDA updated its safety compliance for diabetes drugs, requiring manufacturers to prove that any proposed medications did not increase patients’ potential risks by 30 percent or more. Onglyza initially appeared to meet this mark.
Yet, the SAVOR study (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus—Thrombolysis in Myocardial Infarction 53), conducted by Brigham & Women’s Hospital and published in the New England Journal of Medicine, examined 16,492 patients, all living with Type 2 diabetes and who had or were at high risk for cardiovascular disease. Although Onglyza continued to fall under the 30-percent line, researchers found other concerning statistics: A 27-percent increase in hospitalizations for heart failure and greater all-cause mortality attributed to both cardiovascular and non-cardiovascular conditions.
Because of these findings, the FDA reviewed Saxagliptin’s warning label in 2015. The next year, they put out a formal announcement about their findings, stating that users taking Saxagliptin-based drugs have increased heart failure risks, and required both manufacturers to update their medication’s warning labels.
Since the FDA’s update, multiple patients who developed cardiac conditions as a result of taking a Saxagliptin-based diabetes drug have come forward. As of 2017, an estimated 1,000 multi-district litigation cases are pending at the state level.
Across these cases, plaintiffs experienced congestive heart failure, other adverse cardiac symptoms, and death and allege that both manufacturers failed to adequately warn them and medical professionals about these risks. Furthermore, they claim that AstraZeneca failed to follow the FDA’s 2008 recommendations and, instead, started marketing Onglyza in 2009 without doing sufficient clinical trials.
Were you or a loved one advised to take Onglyza or Kombiglyze XR, only to experience heart failure or another life-threatening cardiac condition after taking it? Trantolo & Trantolo’s dangerous drug attorneys believe that pharmaceutical companies need to be held accountable for their actions, including being less-than-forthright about symptom disclosures, marketing practices, and insufficient warnings. If you believe you have a case, reach out to our team today.