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Onglyza Kombiglyze Heart Failure Lawsuit

Dr. Shezad Malik Law Firm is investigating and accepting personal injury, product liability and wrongful death claims caused by the new diabetes drugs Onglyza and Kombiglyze XR. Filed lawsuits blame the drug manufacturers for causing severe heart failure and death.

What is Onglyza?

OnglyzaDid you or a loved one develop heart failure injuries or die after taking diabetes medications Onglyza (Saxagliptin), made by Bristol-Myers Squibb and AstraZeneca, is used for the treatment of Type 2 diabetes. Onglyzabelongs to a new class of diabetic drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors.

If you or a loved one has taken Onglyza and suffered heart failure and/or death, you may have an injury claim against AstraZeneca. To learn more about your legal rights, call Dr. Shezad Malik Law Firm at 214-390-3189 for a free case review. Dr. Shezad Malik Law Firm is based in Dallas, Texas and is investigating and accepting Onglyza Heart Failure injuries nationwide.

Onglyza received FDA approval inJuly 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. AstraZeneca and Bristol-Myers Squibb jointly developed Onglyza and Kombiglyze, and in 2014, AstraZeneca acquired all global rights to make and sell both of the type 2 diabetes drugs. AstraZeneca is a giant global pharmaceutical company with British-Swedish operations and with headquarters in Cambridge, England.

What are Dipeptidyl peptidase 4 inhibitors?

Dipeptidyl peptidase 4 inhibitors are oral antidiabetes medications 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.

What is Heart Failure?

Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood through to meet the body's needs for blood and oxygen. Basically, the heart can't keep up with its workload.

Congestive heart failure is a type of heart failure, although sometimes the two terms are used interchangeably. Read more here about the types of heart failure.

There are many causes of heart failure in diabetic patients, the four key factors include coronary artery disease, hypertension, diabetic cardiomyopathy (heart muscle weakness), and extra fluid volume.

Type 2 Diabetes linked to heart disease

Type 2 diabetes has been linked to increased risk of heart failure. Almost 50% of patients with type 2 diabetes develop heart failure, and those with both diabetes and established heart failure have worse outcomes. Type 2 diabetes accelerates coronary artery disease.

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.

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 lifetime.

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 are 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.

The FDA added Heart Failure warnings for Onglyza in April 2016. The FDA also has urged patients and healthcare professionals to report Onglyza heart failure side effects to the FDA MedWatch program.

Onglyza (saxagliptin, specifically) also has been linked to an increased risk of pancreatitis and pancreatic cancer.

NEJM Study Found Onglyza Increased Heart Failure Risk

3.5% of patients taking Onglyza were hospitalized for heart failure, compared to 2.8% of those who received a placebo. This is the same as if 1,000 people with type 2 diabetes took Onglyza, 35 of them may be hospitalized for heart failure, compared to 28 people not taking the drug. This data reflected a 27% increased risk of heart failure hospitalization for those on Onglyza.

This NEJM study also found that diabetic patients using Onglyza had increased risk for all-cause mortality or death.

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
Onglyza Heart Failure Lawsuit

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, call Dr. Shezad Malik Law Firm at 214-390-3189 for a free case review. Dr. Shezad Malik Law Firm is based in Dallas, Texas and is investigating and accepting Onglyza Heart Failure Injury cases nationwide.

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