Onglyza Kombiglyze Heart Failure Lawsuit
Dr Shezad Malik Law Firm is investigating the link between new diabetes drugs Onglyza and Kombiglyze XR for causing severe heart failure and death.
What is Onglyza?
Onglyza (Saxagliptin), made by Bristol-Myers Squibb and AstraZeneca, is used for the treatment of Type 2 diabetes. Onglyza belongs to a new class of diabetic drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors.
What are Dipeptidyl peptidase 4 inhibitors?
Dipeptidyl peptidase 4 inhibitors are oral antidiabetes agents that help control blood sugar levels in Type 2 diabetes patients. They block the enzyme dipeptidyl peptidase 4 and regulate the levels of insulin the body produces after a meal.
Dipeptidyl peptidase 4 inhibition results in increased activity of incretins, which blocks glucagon release. This leads to increased insulin release, slows gastric emptying and reduces blood sugar levels.
How common is Heart Failure?
According to the National Heart, Lung and Blood Institute, about 5.7 million people in the United States are living with heart failure and the number is growing. People who are most at risk are those over 65 years old, African Americans, people who are overweight, those who have diabetes and people who have had a heart attack. Men are more likely than women to develop heart failure.
Onglyza and Nesina Medications
Onglyza received FDA approval on July 31st, 2009, and is used to help control high blood sugar in patients with Type 2 diabetes.
Kombiglyze XR is a combination pill of Saxagliptin and metformin extended release medications. Metformin is one of oldest oral diabetic medications and is considered safer.
Other type 2 diabetic medications impacted by the FDA warning include medications containing Alogliptin.
Nesina (Alogliptin) is made by Takeda Pharmaceuticals, Kazano (Alogliptin and metformin) and Oseni (Alogliptin and pioglitazone) medications are also linked to increased heart failure risks.
Medications like Onglyza are designed lower glucose levels and prevent diabetic complications in adults with Type 2 diabetes.
FDA Diabetic Drug Investigations
Type 2 Diabetes is a modern day plague, affecting millions of Americans, according to some experts two thirds of the adult American population may have or may develop type 2 diabetes during their life time.
Type 2 diabetes patients have a significantly increased risk of severe heart disease side effects and the majority of diabetics die from these complications.
Diabetic medications used to treat type 2 diabetes have major side effects and there is 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.
Though the FDA approved the new diabetic drug Onglyza, it had reservations about the Onglyza clinical trials and ordered AstraZeneca to perform a post-marketing study looking at cardiovascular safety criteria.
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 (NEJM) and raised major Onglyza safety concerns.
Study Found Onglyza Linked to Increased Heart Failure Risk
Type 2 diabetes patients who take Onglyza may be at increased risk for heart failure. Onglyza users may also face a higher risk of death overall.
The 2013 study in the NEJM found that, compared to a placebo (blank medication) Onglyza use resulted in a 27% increase in patient hospitalization from heart failure.
This NEJM study also found that diabetic patients using Onglyza had increased risk for all-cause mortality or death.
Based on the NEJM study findings, the FDA added warnings about heart failure risk to labels of type 2 diabetes medicines containing Onglyza and Nessina.
According to the Food and Drug Administration (FDA), Onglyza users may face an increased risk of congestive heart failure. In 2014, a FDA advisory committee recommended that Onglyza labeling be updated to warn against heart failure risk—a warning that was previously not included on the medication’s label.
Onglyza Heart Failure Injuries
Patients taking these medicines should contact their doctors right away if they develop signs and symptoms of heart failure such as:
- Unusual shortness of breath during daily activities
- Trouble breathing when lying down
- Tiredness, weakness, or fatigue
- Weight gain with swelling in the ankles, feet, legs, or stomach
If you or a loved one has taken Onglyza or Nesina and suffered heart failure and/or death, you may have a case for compensation against AstraZeneca and Takeda Pharmaceuticals. To learn more about your legal rights, contact Dr Shezad Malik Law Firm for a free case review.
Onglyza lawsuits allege that:
- Bristol-Myers Squibb AstraZeneca manufactured a dangerous medication
- Bristol-Myers Squibb AstraZeneca failed to adequately warn doctors and patients about possible dangers
- Bristol-Myers Squibb AstraZeneca improperly marketed medications
- Bristol-Myers Squibb AstraZeneca knew about the dangers and chose to market the drug anyway