What’s the Problem?
In 2011, an FDA advisory committee recommended that AstraZeneca Pharmaceuticals LP withdraw the prescription drug Onglyza, a recently-approved type 2 diabetes drug. In their monthly newsletter, Worst Pills Best Pills, the group urged consumers to wait seven years, or until 2016, before they use Onglyza so that more long-term data is available about its potential risks and benefits.
Even though the dangerous drug only gained FDA approval in 2009, Onglyza has already been closely scrutinized by the Food and Drug Administration. The administration has requested that drugmaker Bristol-Myers Squibb conduct post-marketing studies, and has expressed concerns about the drug’s heart risks, liver toxicity, and potential skin reactions.
The FDA approved Onglyza for the treatment of type-2 diabetes, and belongs to a class of medications known as incretin mimetics, according to the Metabolic Drugs Advisory Committee. The first drug from this class, Januvia, is listed on Public Citizen’s ‘Do Not Use’ list.
Another incretin mimetic called Galvus has been approved in Europe but was rejected by the Centers for Disease Control due to concerns about liver toxicity and severe allergic reactions, including Stevens-Johnson Syndrome (SJS).
Additionally, the New England Journal of Medicine noted that Onglyza and Kombiglyze XR are only designed for managing type 2 diabetes, and that some have mistaken this to mean that the drugs will reduce the increased risk of stroke.
However, Onglyza and other incretin mimetics are only intended to treat diabetes symptoms, like frequent urination and thirst. No diabetic drugs on the market are allowed to say that they can reduce the risk of heart attack or stroke.
Onglyza Side Effects
Serious side effects associated with Onglyza include:
- Pancreatitis and Pancreatic Cancer
- Thyroid Cancer
- Heart Failure risk
- Acute Pancreatitis
- Hemorrhagic Pancreatitis
- Necrotizing Pancreatitis
- Kidney Complications
- Renal Failure
- Potentially life-threatening cardiovascular outcomes recorded
- Cardiovascular disease
- Heart complications
- Heart disease
- All cause mortality
Other, less severe Onglyza side effects may include:
- Allergic reactions including hives, difficulty breathing, and swelling of the face, lips, tongue, or throat
- Unexplained muscle pain or weakness
- Joint pain
- Memory problems
- Unusual tiredness
- Dark colored urine
- Weight gain
- Urinating less than usual or not at all
- Severe pain in the upper stomach spreading to your back
- Cardiovascular events
- Loss of appetite
- Fast heart rate
- Increased thirst
- Increased urination
- Dry mouth
- Fruity breath odor
- Dry skin
- Blurred vision
- Weight loss
- Dark urine
- Clay-colored stools
- Jaundice (yellowing of the skin or eyes)
- Severe skin reactions
- Sore throat
- Swelling in the face or tongue
- Burning in they eyes
- Skin pain
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Pancreatitis & Pancreatic Cancer
Recent studies have found an increased risk of acute pancreatitis in diabetes patients treated with incretin mimetic drugs. One such study , published in Feb. 2013 by Dr. Sonal Singh of Johns Hopkins University School of Medicine and Public Health, found a doubled risk of pancreatitis for incretin mimetic users.
"Since most risk factors for acute pancreatitis are also linked to an increased risk of pancreatic cancer, these findings of changes in the human pancreas are very concerning," said Dr. Singh.
A month after these findings were published, another study  from researchers at UCLA and the University of Florida found that incretin mimetics cause abnormal pancreatic growth in humans that may be linked to neuroendocrine tumors, which could increase the risk of pancreatic cancer.
FDA Warning on Incretin Mimetic Pancreatic Cancer Risk
On March 14, 2013, an FDA Drug Safety Communication announced that the agency had launched an investigation into the link between incretin mimetic drugs and pancreatic cancer.
The agency said it will review academic researchers’ findings and asked researchers to provide the methodology they used to collect and study specimens which showed pancreatic damage so that it could further investigate potential health risks associated with the medications.
Which Drugs are Incretin Mimetics?
In addition to Onglyza, other incretin mimetics include:
- Byetta (exenatide)
- Bydureon (exenatide)
- Janumet (metformin and sitagliptin)
- Janumet XR (sitagliptin and metformin HCl extended-release) 
- Januvia (sitagliptin)
- Jentadueto (linagliptin and metformin)
- Kazano (alogliptin and metformin)
- Kombiglyze XR (saxagliptin and metformin)
- Nesina (alogliptin)
- Oseni (alogliptin and pioglitazone)
- Tradjenta (linagliptin)
- Victoza (liraglutide)
Onglyza Lawsuits Centralized in Kentucky
February 5, 2018 - JPML has voted to consolidate all federal lawsuits on behalf of patients who suffered heart failure from Onglyza and Kombiglyze XR into a multidistrict litigation for pretrial handling in the Eastern District of Kentucky. The Panel issued an Order transferring all such claims to the United States Federal Court, which will be overseen by the Honorable Karen K. Caldwell.
Bristol-Myers Squibb, AstraZeneca Sued for Onglyza Risk of Heart Failure
July 24, 2017 - A New Jersey man who claims that he developed coronary artery disease and congestive heart failure after taking Kombiglyze XR has filed a products liability lawsuit against Bristol-Myers Squibb and AstraZeneca Pharmaceuticals in the Eastern District of Kentucky.
Plaintiff Earl Binns alleges that the drugmakers are responsible for his injuries because they had known for years that the diabetes drug could increase the risk of heart damage.
Texas Man Alleges Heart Failure from Onglyza, Kombiglyze XR
March 10, 2017 - A Texas man has filed a products liability lawsuit in California District Court alleging that Onglyza and Kombiglyze XR caused him to develop heart failure. Plaintiff Wrendell Chester claims through his Onglyza lawyer that he took both drugs to treat his type 2 diabetes from 2010 to 2015, after which he suffered congestive heart failure, heart failure and acute hypoxic respiratory failure as a result of side effects of the medications.
Study Highlights Heart Failure Risk of Combining Onglyza with Other Diabetes Drugs
June 23, 2016 - A new study published in the British Medical Journal (BMJ)  has found that combining DPP-4 inhibitors like Onglyza with drugs in the "sulphonylurea" class may increase the risk of hypoglycemia (control blood sugar), a life-threatening condition.
The researchers cautioned that physicians should “respect recommendations for a decrease in sulphonylureas dose when initiating DPP-4 inhibitors.”
Onglyza Labels Updated to Include Increased Risk of Heart Failure Warning
April 5, 2016 - Type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure and cardiovascular safety, particularly in patients with a history of heart or kidney disease, according to an FDA Drug Safety Alert issued today. As a result of these problems, new warnings will be added to the labeling of all saxagliptin and alogliptin-containing medications.
The findings are from an evaluation of a large clinical trials which found that more patients were hospitalized for heart failure who received DPP-4 diabetes drugs compared to those who took a placebo.
Food and Drug Administration Issues Joint Pain Warning for DPP-4 Inhibitors
A class of diabetes medications that includes Onglyza has been linked to severe joint pain, according to an FDA warning issued August 28, 2015.
Patients who have been injured by Onglyza side effects may allege that AstraZeneca:
- Failed to conduct a sufficient pre-market clinical trial
- Failed to adequately warn doctors and patients about cardiovascular safety
- Fraudulently or negligently marketed the drug
- Marketed Onglyza despite having knowledge of inherent dangers
Has a Class Action Lawsuit Been Filed?
Although we are a nationally recognized class action firm, the Products Liability Litigation Group at Schmidt & Clark, LLP, has decided against the filing of an Onglyza Class Action Lawsuit, and is currently filing individual claims on behalf of individuals and/or their family members who developed cancer or heart failure after using Onglyza.
See all defective pharmaceutical lawsuits that we've taken on.
Get a Free Onglyza Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Onglyza lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Again, if you developed pancreatic cancer or heart failure after taking Onglyza, you should contact our law firm immediately for a free case review. You may be entitled to compensation by filing a suit for legal fees and our defective drug lawyers can help with a free case evaluation.