Onglyza Heart Failure FAQs

Onglyza is a drug used to treat type 2 diabetes. Experts and the FDA have linked the drug to severe health risks. The medical community heralded the drug as a "promising new treatment option." Many experts saw it as one of the most critical advancements in diabetes treatment since insulin.

Many argue that Onglyza causes an increased risk of heart failure. In 2023, the manufacturer took the drug off the market. Still, the company that sells Onglyza, AstraZeneca, has been the target of legal action for failing to warn the public about these risks.

Here, we will answer frequently asked 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?
• Onglyza, Heart Failure, and Your Options: Contact an Attorney

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.

Onglyza, Heart Failure, and Your Options: Contact an Attorney

If you took Onglyza or other diabetes medication for the treatment of type 2 diabetes and developed heart disease, contact a personal injury attorney. The last thing you want to deal with is another health condition.

If you believe the drug contributed to your heart failure, you may be able to file a claim for damages.