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CASE UPDATE: Onglyza Heart Failure Lawsuits Consolidated
February 2018: 80 Onglyza heart failure lawsuits were consolidated before the U.S. District Court, Eastern District of Kentucky.
Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCl extended-release) are part of a class of medications known as Incretin Mimetics, which is further divided into a category called dipeptidyl peptidase-4 (DPP-4) inhibitors. Used for individuals suffering from Type 2 diabetes who do not suffer from diabetic ketoacidosis, the intended purpose of these Type 2 diabetes drugs is to stimulate insulin production in the pancreas after meals to control blood sugar.
Kombiglyze XR is a longer-acting version, which combines Onglyza with metformin, an older Type 2 diabetes drug.
Onglyza and Kombiglyze XR are both manufactured by AstraZeneca and Bristol Myers Squibb. They can potentially increase the risk of severe, potentially life-threatening side effects, and in an Onglyza heart failure lawsuit and Onglyza pancreatic cancer lawsuit that has been filed, plaintiffs allege the drugs increased the risk of both heart failure and pancreatic cancer.
The drugs have allegedly caused pancreatitis, pancreatic cancer, heart failure, congestive heart failure, and death. Were you injured as a result of Onglyza or Kombiglyze XR? You may qualify for an Onglyza heart failure lawsuit or an Onglyza pancreatic cancer lawsuit.
Cardiovascular disease is the most common causes of death of both men and women in the United States. According to the CDC, “about 610,000 people die of heart disease in the United States every year – that’s 1 in every 4 deaths.”
Heart failure, a type of cardiovascular disease, can occur when the heart isn’t pumping as much blood as it should be. This prevents the body from obtaining the required amount of blood and oxygen needed to function. If left untreated, heart failure can get worse, inevitably causing potentially deadly health consequences.
For Type 2 diabetes patients taking Onglyza, the connection between the drug and cardiovascular risks is alarming. Due to a growing concern, the U.S. Food & Drug Administration (FDA) opened up an investigation between the drug and the connection to heart failure in 2015. As a result of that investigation, additional warnings were issued to include the risk of heart failure on both Onglyza and Kombiglyze XR.
According to the National Cancer Institute, there were an estimated 68,615 people living with pancreatic cancer in the United States in 2015. It is one of the deadliest cancers because it often goes undetected until its later stages making it difficult to treat.
In 2011, Pancreatitis was added to both Onglyza and Kombiglyze XR’s warning labels. Serious cases can result in pain and suffering, hospitalization, or even death. Pancreatitis can also sometimes be a precursor to pancreatic cancer. In 2013, the FDA launched an investigation into the connection between Onglyza and pancreatic cancer.
TorHoerman Law is currently accepting cases involving the following injuries:
If you believe you were injured as a result of Onglyza or Kombiglyze XR’s dangerous side effects, please contact our personal injury lawyers today for a free, no-obligation consultation today.
February 2017 - A diabetes drug lawsuit was filed on behalf of a man who alleges he suffered heart failure, congestive heart failure and acute hypoxic respiratory failure as a result of Onglyza and Kombiglyze XR usage.
April 5, 2016 - A drug safety communication was issued to include heart failure warnings for the following drugs: Onglyza and Kombiglyze XR. The label now lists these possible side effects.
April 2015 - The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted to include stronger warnings of the potential Onglyza heart risks after results of two studies were published in the New England Journal of Medicine.
March 14, 2013 - The FDA launched an investigation into Onglyza and the potential for increased risks of developing pancreatitis and pancreatic cancer.
February 11, 2014 - The FDA launched a safety review of the alleged increased risk of heart risks associated with Onglyza.
2010 - Kombiglyze XR is approved for sale by the FDA.
2009 - The FDA approved Onglyza for sale.
Ault, Alicia. “FDA Panel Backs New Safety Warnings on Two Diabetes Drugs.” Medscape, 14 Apr. 2015, www.medscape.com/viewarticle/843179
“Cancer Stat Facts: Pancreatic Cancer.” Surveillance, Epidemiology, and End Results Program, National Cancer Institute, seer.cancer.gov/statfacts/html/pancreas.html
“FDA Drug Safety Communication: FDA Adds Warnings about Heart Failure Risk to Labels of Type 2 Diabetes Medicines Containing Saxagliptin and Alogliptin.” U.S. Food and Drug Administration Home Page, U.S. Department of Health and Human Services, www.fda.gov/Drugs/DrugSafety/ucm486096.htm
“FDA Drug Safety Communication: FDA Investigating Reports of Possible Increased Risk of Pancreatitis and Pre-Cancerous Findings of the Pancreas from Incretin Mimetic Drugs for Type 2 Diabetes.” U.S. Food and Drug Administration, U.S. Department of Health and Human Services, www.fda.gov/Drugs/DrugSafety/ucm343187.htm
“FDA Drug Safety Communication: FDA to Review Heart Failure Risk with Diabetes Drug Saxagliptin (Marketed as Onglyza and Kombiglyze XR).” U.S. Food and Drug Administration, U.S. Department of Health and Human Services, wayback.archive-it.org/7993/20170112031610/http://www.fda.gov/Drugs/DrugSafety/ucm385287.htm
“Heart Disease Facts.” Heart Disease, Centers for Disease Control and Prevention, 28 Nov. 2017, www.cdc.gov/heartdisease/facts.htm
Helfand, Carly. “Bristol-Myers, AstraZeneca in Legal Hot Seat over Onglyza Heart Failure Warning.” FiercePharma, 8 May 2017, www.fiercepharma.com/pharma/az-bms-slapped-14-lawsuits-over-onglyza-heart-failure-risks
“Onglyza Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing.” WebMD, WebMD, www.webmd.com/drugs/2/drug-152753/onglyza-oral/details
“Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus | NEJM.”New England Journal of Medicine, Oxford University Press, 3 Oct. 2013, www.nejm.org/doi/full/10.1056/NEJMoa1307684
“What Is Cardiovascular Disease?” American Heart Association, www.heart.org/HEARTORG/Conditions/What-is-Cardiovascular-Disease_UCM_301852_Article.jsp#.WvyCxNPwb-Y
Last Modified: May 13th, 2019 @ 11:48 am
Onglyza and Kombiglyze XR are two medications used to treat Type 2 diabetes, but in recent years, have generated concern in regards to the dangerous side effects associated. Lawsuits alleging the drugs caused heart failure and pancreatic cancer have been filed. If you believe you suffered as a result of Onglyza's serious side effects, contact a lawyer today.
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