Onglyza the oral diabetes treatment designed to control blood sugar in patients with Type 2 diabetes, otherwise known as adult onset diabetes, has been linked by studies and lawsuits to serious side effects, which can result in death. Once heralded as the biggest breakthrough in diabetes treatment since insulin, patients using the drug face higher than normal risks of developing heart failure, and/or pancreatic cancer.
What is Onglyza?
Onglyza, a pill taken by mouth containing the active ingredient, saxagliptin, was approved by the U.S. Food and Drug Administration (FDA) in 2009. This drug along with Kombiglyze XR were developed jointly, by AstraZenica and Bristol Meyers Squibb, to treat Type 2 Diabetes sufferers to control high blood sugar for those who did not also suffer from diabetic ketoacidosis.
These medications belong to a class of drugs called incretin mimetics. These DPP-4 inhibitors cause the pancreas to secrete more insulin, and stop the liver from making excess sugar. The intended effect is to control high levels of blood sugar without weight gain.
Side Effects of Onglyza
DDP-4 inhibitors have been widely prescribed since their approval, and dangerous side effects began to surface shortly after widespread use of the drug. As early as 2011, the consumer advocacy organization, Public Citizen, urged patients to not to use the drug until the side effects could be studied further.
Also in that year, the medical journal, “Gastroenterology,” reported that the risks of pancreatic cancer were as high as 2.7 times greater among users of Onglyza than other diabetes sufferers. That year, the FDA required warning labels placed on the drug, warning of pancreatitis.
In 2013, the Journal of the American Medical Association, JAMA, reported serious increased risks of pancreatic cancer, and a study was released showing users of the drug were more likely to be hospitalized for heart failure.
The New England Journal of Medicine published results of a study of over 16,000 patients, showing that patients using Onglyza were nearly 30% more likely to be hospitalized for heart failure, than diabetes patients not using the drug.
Onglyza Regulatory Warnings and Lawsuits
As a result of these studies, the FDA launched an investigation of the drug. The FDA investigation concluded in 2015 with the requirement that AstraZenica place a warning label of increased risk of heart failure on the drug in addition to the warning of pancreatitis that it had previously required.
In 2015, a lawsuit was filed by the daughter of a deceased patient who began using the drug in 2010, and died of complications from heart failure in 2013. The suit alleges that the company manufactured a dangerous medication that it knew was connected to dangerous side effects, but that it failed to warn the medical community and the public of potential dangers from use of the drug, while spending millions of dollars marketing the drug. Hundreds of additional suits have been filed since, with similar allegations.
Also in 2015, Express Scripts, a national prescription drug insurance provider, dropped Onglyza from its National Preferred Formulary, the most widely used formulary in the U.S. Express Scripts coverage guidelines affect which drugs are insured for over 25 million Americans.
Sales of Onglyza have reached nearly $800 million annually, with projections showing possible increases to over $2 billion by 2018.
Symptoms associated with Pancreatic Disease include:
- Upper Abdominal Pain
- Loss of Appetite
- Weight Loss
Symptoms of Heart Failure include:
- Difficulty breathing especially when lying down
- Swelling of the hands feet ankles
- Irregular heart beat
- Persistent Cough
Nevada Onglyza Legal Representation
If you, or a loved one have been prescribed the medication, Onglyza, and have suffered symptoms like those described above, we want to speak with you to determine your eligibility to file a lawsuit against the drug manufacturer, for intentionally marketing a drug it knew to be dangerous, without warning you or your doctor of the risks. Please call us at 702-444-4444 to speak with our representative further.