Onglyza Legal Information and FAQ

Onglyza is a type 2 diabetes drug manufactured by AstraZeneca Pharmaceuticals LP. The U.S. Food and Drug Administration FDA approved the drug, also known as saxagliptin, in 2009. The drug has become a popular diabetes medication, but it also causes serious health complications. For example, studies show the drug causes an increased risk of heart failure, pancreatitis, and pancreatic cancer.

As a result, diabetes patients have filed hundreds of Onglyza lawsuits nationwide. Most plaintiffs argue that the drugmaker failed to warn them of the drug’s dangerous side effects. Many others filed wrongful death lawsuits against AstraZeneca after their loved ones died.

This article discusses Onglyza’s side effects and heart failure and pancreatic cancer litigation. It also answers several common questions about the drug’s association with heart failure. If you have been harmed by Onglyza or another pharmaceutical, contact a product liability attorney near you for personalized legal advice.

What Is Onglyza?

Onglyza is a DPP-4 inhibitor used to help regulate blood sugar levels/blood glucose levels. It’s not the only medication that works this way. Other drugs like alogliptin, metformin, and Kombiglyze XR also treat type 2 diabetes. The difference is that these other drugs do not pose the severe side effects Onglyza poses.

Since its FDA approval in 2009, Onglyza has become a critical product for AstraZeneca.

Doctors grew concerned after the FDA’s SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) study found that patients who took Onglyza had a 27% greater risk of developing congestive heart failure and other cardiovascular diseases.

In April 2015, the FDA recommended that drugmakers include a warning label indicating an increased risk for heart failure. The drug company ignored this advice.

Onglyza Lawsuits: Heart Failure

Researchers published the results of the SAVOR study in the New England Journal of Medicine in 2013. By 2015, the FDA issued warnings about Onglyza’s increased risk of heart failure. The FDA issued a drug safety communication recommending that the drugmakers add a warning about this risk to their packaging. AstraZeneca and Bristol-Myers Squibb failed to take this advice.

Both drug companies continued to market Onglyza without the warnings. As a result, hundreds of patients sued the drug companies. The courts consolidated the cases, and Kentucky Judge Karen Caldwell oversaw the litigation.

The courts formed a second multi-district litigation (MDL) case before Judge Anna-Christine Massullo in a California district court. In both MDLs, the judges granted summary judgment in favor of the defendant drugmakers.

The plaintiffs only had one expert witness, who relied on just one clinical trial in their testimony. The judges held this was insufficient and excluded the expert from testifying at trial.

The defendants filed motions for summary judgment, which the judges granted. Thus, the MDL in both states is essentially dead.

In addition to the multi-district litigation in Kentucky and California, hundreds of plaintiffs filed suits in state courts. None of these class action lawsuits have settled as of 2023.

Onglyza Lawsuits: Pancreatic Cancer

In addition to heart failure, people who took other dipeptidyl-peptidase 4 (DPP-4) inhibitors similar to Onglyza also claim they developed pancreatitis and pancreatic cancer after taking these drugs.

Plaintiffs who believe their pancreatic cancer was due to taking Onglyza and other incretin mimetic drugs saw the courts consolidate their lawsuits into a California MDL. The plaintiffs’ counsel named several drug manufacturers in the lawsuits.

The California judge overseeing the pancreatic cancer MDL granted a motion for summary judgment in favor of the drugmakers. The judge dismissed the litigation for the same reasons the Kentucky judge did. The judge found that there was a lack of expert evidence.

Onglyza and Heart Failure: FAQ

Below, you’ll find answers to questions about Onglyza, the risk of heart failure, and your legal options if this drug hurts you.

• What are DPP-4 Inhibitors?
• Which drugs are DPP-4 inhibitors?
• Is Onglyza safe for people with heart failure?
• What is heart failure, and what are the most common symptoms?
• Does Onglyza have other side effects?
• What do I do if I develop heart failure after taking Onglyza?
• Are there any lawsuits against AstraZeneca?

What are DPP-4 inhibitors?

Patients take DPP-4 inhibitors (dipeptidyl peptidase-4) to treat type 2 diabetes. The medications help lower your blood sugar. Our bodies naturally produce DPP-4. It’s an enzyme that breaks down a hormone called incretin. Incretin allows your body to produce insulin and reduce glucose. DPP-4 interferes with patients’ blood sugar levels by breaking down this hormone.

DPP-4 inhibitors like saxagliptin and alogliptin allow people with type 2 diabetes to maintain lower blood sugar levels by inhibiting DPP-4s from doing their job.

Which drugs are DPP-4 inhibitors?

Saxagliptin and alogliptin comprise the family of drugs called DPP-4 inhibitors. Onglyza is not the only DPP-4 inhibitor. There are several of these on the market. Different pharmaceutical companies have versions of the medication.

The DPP-4 inhibitors that AstraZeneca sold until 2023 were Onglyza and a time-release version of the drug called Kombiglyze XR.

Some of the other DPP-4 inhibitors include:

• Sitagliptin
• Saxagliptin
• Linagliptin
• Alogliptin

Most patients take these drugs in combination with another diabetes medication, such as metformin.

As briefly stated, AstraZeneca officially removed Onglyza and Kombiglyze XR from the market in 2023. The drug company indicated that it did this for business reasons and not because of the lawsuits alleging that its drug causes heart failure.

Is Onglyza safe for people with heart failure?

People with a history of heart failure should not take Onglyza. Several studies showed a possible link between the drug and various cardiovascular issues. For example, the FDA evaluated two drug clinical trials in 2015. It found that there was a slight increase in hospitalization due to heart failure compared with those who took a placebo.

Following the evaluation of these clinical trials, the FDA added warnings about the increased risk of heart failure in patients taking Onglyza and other drugs containing saxagliptin and alogliptin. The risk is exceptionally high among patients with a history of heart or kidney disease.

Two years earlier, cardiologist Dr. Anthony DeMaria, editor-in-chief of the Journal of the American College of Cardiology, suggested that patients at high risk of heart failure should avoid DPP-4 inhibitors (including Onglyza). A study published in 2014 by the New England Journal of Medicine raised similar concerns about saxagliptin and heart failure.

What is heart failure, and what are the most common symptoms?

Heart failure is the inability of the heart to pump enough blood to meet the body’s needs. Diabetes, coronary heart disease, and hypertension are the main risk factors for developing congestive heart failure.

Symptoms of heart failure include the following:

• Acute shortness of breath during normal (not necessarily strenuous) activities
• Difficulty breathing while lying down
• Fatigue, weakness
• Dizziness
• Rapid or irregular heartbeat
• Weight gain and swelling in the stomach or lower body

The plaintiffs who sued AstraZeneca complained of these symptoms. That’s how their doctors diagnosed their heart failure.

If you experienced the same thing, you should immediately talk to a product liability lawyer. If your loved one died from heart failure after taking Onglyza, you may be able to file a wrongful death claim.

Does Onglyza have other side effects?

Onglyza had other side effects aside from the cardiovascular risks. This is the case for most prescription medications.

Some of the common side effects of Onglyza and Kombiglyze XR (Oglyza extended release) include the following:

• Rash
• Hives
• Itching skin
• Hoarse voice
• Loss of appetite

The FDA and medical experts have linked Onglyza (saxagliptin) to an increased risk of pancreatitis and pancreatic cancer. But most Onglyza lawsuits involve heart failure, not pancreas conditions.

What do I do if I develop heart failure after taking Onglyza?

If you experienced any of the symptoms associated with heart failure while taking Onglyza or any DPP-4 inhibitor, talk to your healthcare provider. Depending on the severity of the condition, your doctor may recommend oxygen therapy. They may also prescribe cardiac medication.

If particularly severe or left untreated, heart failure may need hospitalization. Some patients also need surgery to prevent a heart attack or other serious complications. If you prove your medical issues are due to taking Onglyza, you may have a legal claim against AstraZeneca for failing to warn about the health risks.

Are there any lawsuits against AstraZeneca?

There are still about 250 Onglyza lawsuits pending an appeal. In August 2022, District Judge Karen Caldwell excluded the plaintiff’s expert witness in the multi-district litigation. Attorneys for AstraZeneca and the other defendants, Bristol Myers Squibb and their distributor McKesson, filed a motion asking that the judge exclude the plaintiffs’ expert witness.

The judge granted their motions, finding that the epidemiologist’s methodologies were unreliable. This expert’s testimony was the plaintiffs’ only big weapon to support their case. The plaintiffs appealed the exclusion of their expert. The oral argument in this appeal is in late 2023. The U.S. Court of Appeals for the Sixth Circuit has not yet decided. Things don’t look promising for the remaining plaintiffs.

In 2023, a state court Onglyza action that consolidated 13 Onglyza cases concluded. The appellate court affirmed the trial court’s exclusion of the plaintiffs’ expert general causation witness. Without an expert opinion on causation, summary judgment dismissing the case followed, ending the litigation for the plaintiffs in the state court cases.

The manufacturer removed the drug from the market at the beginning of 2023. This means the likelihood of new plaintiffs filing claims is low.

Harmed by Onglyza? Get Legal Help

You may be eligible for damages if you or a loved one suffered adverse side effects after using Onglyza. Depending on the facts of your case, you may need to file a product liability or wrongful death lawsuit against the drugmakers, AstraZeneca and BMS.

An excellent first step is to contact an experienced dangerous drug attorney familiar with this issue and schedule your free case review. Whether you file a heart failure lawsuit or one for cancer of the pancreas, you will want a skilled injury lawyer by your side.

Most attorneys offer new clients a free case evaluation. This allows you to have an expert review your claim and help determine how best to proceed. FindLaw’s directory of personal injury attorneys can get you started. Select your state or city to review contact and ratings information for local experts.