Onglyza and others in a class of drugs used to treat type 2 diabetes have been linked to serious health risks. Active ingredient saxagliptin and other dipeptidyl peptidase-4 (DPP-4) inhibitor drugs (also called gliptins) once were heralded as a "promising new treatment option" and one of the most important advancements in diabetes treatment since insulin. But now, Onglyza and other brands of medications containing DPP-4 inhibitors have been blamed for an increased risk of heart failure. The company that sells Onglyza, AstraZeneca, has been the target of legal action for failing to warn the public about these risks.
The following are answers to some of the most frequently asked questions about Onglyza, heart failure, and legal options for those injured by this drug. Get immediate medical attention if you take Onglyza or any other DPP-4 inhibitor and have suffered symptoms linked to its health risks.
Q: What are DPP-4 inhibitors and how are they used to treat type 2 diabetes patients?
DPP-4 inhibitors -- which include saxagliptin and alogliptin -- are used (along with exercise and a healthy diet) to lower blood sugar in those with type 2 diabetes. DPP-4 is a naturally occurring enzyme that breaks down the hormone incretin. Since incretin helps the body produce insulin or reduce glucose (as needed) -- processes that are deficient in those with type 2 diabetes -- DPP-4 inhibitors have the effect of lowering blood sugar.
Q: Which drugs are categorized as DPP-4 inhibitors?
Saxagliptin and alogliptin make up the family of drugs referred to as DPP-4 inhibitors. In addition to Onglyza, AstraZeneca also sells a time-released version of the drug under the name Kombiglyze XR. A similar drug using the DPP-4 inhibitor algoliptin is sold in Europe by Takeda UK Ltd.
Q: What do we know about Onglyza's heart failure risk?
As early as 2013, cardiologist Dr. Anthony DeMaria, editor-in-chief of the Journal of the American College of Cardiology, suggested that DPP-4 inhibitors (including Onglyza) were probably best avoided by patients at high risk of heart failure.
In 2015, the Food and Drug Administration (FDA) evaluated two clinical trials of Onglyza in type 2 diabetes patients with a history of heart disease, which showed a slight increase in hospitalization due to heart failure when compared to those who were given a placebo. The data showed that 2.8 percent of the patients given a placebo developed heart failure, compared to 3.5 percent of patients given saxagliptin (the active ingredient in Onglyza). The FDA requested this data in February 2014 after a study published by the New England Journal of Medicine raised similar concerns about saxagliptin and heart failure.
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 particularly high among patients with a history of heart or kidney disease.
Q: What is heart failure, and what are the most common symptoms?
Heart failure is defined as the inability of the heart to pump enough blood to meet the body's needs, either because it can't fill with enough blood or lacks the ability to pump blood with adequate force. This is different from cardiac arrest, in which the heart stops working. Diabetes, along with coronary heart disease and hypertension, are the main risk factors for developing heart failure.
The symptoms of heart failure include the following:
Q: Has Onglyza (and DPP-4 inhibiting drugs in general) been associated with other notable side effects?
Yes. Onglyza (saxagliptin, specifically) also has been linked to an increased risk of pancreatitis and pancreatic cancer. Other, less-severe side effects may include rash, hives, itching skin, hoarseness, and loss of appetite.
Q: What should I do if I suspect I'm developing heart failure after taking Onglyza?
If you have experienced any of the symptoms associated with heart failure, do not stop taking the drug but seek immediate medical attention. Depending on the severity of the condition, your doctor may recommend oxygen therapy and a change in medication. If particularly severe or left untreated, heart failure may require hospitalization or even surgery in order to prevent a heart attack or other serious complications. You also may have a legal claim against Onglyza manufacturer AstraZeneca for failing to warn consumers about these risks.
Onglyza, Heart Failure, and Your Options: Contact an Attorney
If you are taking Onglyza or similar medications for the treatment of type 2 diabetes, the last thing you want to deal with is another health condition. But if you believe use of the drug contributed to your heart failure, you may be able to file a claim for your injuries. Contact an injury law attorney familiar with this issue right away to hear about your options.
Contact a qualified product liability attorney to make sure your rights are protected.