Onglyza (generic name saxagliptin) is a prescription medication used to lower blood sugar in patients with type 2 diabetes. AstraZeneca manufactures Onglyza, which the U.S. Food and Drug Administration (FDA) classifies as a DPP-4 inhibitor. This class of drugs assists the pancreas with insulin secretion and stops the liver from producing excess sugar.
But the drug may be associated with serious complications including heart failure and pancreatic cancer. This has led some patients and their families to file lawsuits against the manufacturer alleging improper testing and deceptive marketing practices, which they say contributed to their medical conditions.
The FDA approved Onglyza for the treatment of type 2 diabetes in adults. When used in combination with proper diet and exercise, Onglyza may help lower blood sugar in diabetic patients. Patients must still monitor their blood sugar levels while taking the drug. Onglyza is not for people with type 1 diabetes or diabetic ketoacidosis.
Onglyza and the Risk of Heart Failure
In April 2015, the FDA required Onglyza to carry a warning about the risk of heart failure. The SAVOR study found that of the nearly 16,500 patients in the study, those who took Onglyza had a 27 percent greater risk of hospitalization for heart failure than the control group.
While heart failure is not always fatal, it does reduce quality of life and puts the patient at risk for more cardiovascular complications. Symptoms of heart failure include:
- Difficulty breathing
- Swelling of hands, feet, or ankles
- Irregular heart rate
- Persistent cough or wheezing
Onglyza and the Risk of Pancreatic Complications
In November 2011, the FDA added a warning to Onglyza regarding the risk of pancreatitis. This condition causes the pancreas to become inflamed and serious cases can require hospitalization or result in death. Symptoms of pancreatitis may include:
- Upper abdominal pain
- Abdominal pain that radiates to your back or worsens after eating
- Rapid pulse
- Nausea and vomiting
- Abdominal tenderness
The FDA warning instructs doctors to discontinue Onglyza in their patients if they suspect or diagnose pancreatitis. Pancreatitis can increase the risk of pancreatic cancer, which has become another concern with the drug.
In a 2013 study, researchers autopsied the pancreases of deceased patients who took drugs similar to Onglyza. Many of these patients had pre-cancerous cells in their pancreas. The study found that DPP-4 drugs like Onglyza can increase the number and size of beta cells in the pancreas. These cells may become abnormal and may form small, benign tumors that can become malignant.
Other Onglyza Side Effects and Complications
Onglyza lists common side effects such as:
- Upper respiratory tract infections
- Urinary tract infections
- Nausea, vomiting, diarrhea
- Stuffy or runny nose
- Sore throat
Side effects related to allergic reactions may include:
- Swelling of the face, lips, or throat
- Difficulty swallowing or breathing
- Swelling of the skin
- Hives, rash, itching, or flaking or peeling skin
Furthermore, there are possible complications associated with Onglyza use with other medications. Patients taking another medication to treat diabetes might experience low blood sugar. Patients taking a thiazolidinedione (TZD) medication such as pioglitazone may experience swelling or fluid retention in the hands, feet, or ankles. Even vitamins or supplements may affect prescription drugs like Onglyza, so patients should inform their doctor of all medications they are taking.
Patients who experience side effects or complications while taking the drug should inform their doctor immediately.
The Connection Between Onglyza and Kombiglyze XR
Kombiglyze XR is a combination drug containing Onglyza and Metformin, another popular diabetic medication. Because Kombiglyze XR contains Onglyza, patients taking this medication should be aware of the same risks as patients who take Onglyza alone.
Diabetic Drugs and Cardiovascular Risks
In 2008, the FDA released new recommendations for evaluating cardiovascular risks associated with new type 2 diabetes drugs, like Onglyza. Some drugs like Onglyza met the basic criteria for low incidence of heart attacks, but the FDA called those initial tests into question.
Onglyza’s manufacturer, AstraZeneca, claimed the drug decreased the risk of cardiovascular events and wanted to include this in the drug’s prescribing information. However, the FDA denied the request, citing lack of supporting data. Only after pressure from the FDA did AstraZeneca perform more extensive post-marketing testing which revealed the increased risk of heart failure. This new data led the FDA to require the warning of heart failure on Onglyza materials.
If You Suffered Complications from Onglyza, You Might Have a Legal Case
Several patients and their families have filed lawsuits against Onglyza’s manufacturer, AstraZeneca. These lawsuits claim AstraZeneca deceptively marketed Onglyza and did not sufficiently test it before gaining approval and marketing the drug, thus failing to recognize many potential risks such as heart failure.
If you are a patient who is taking or has taken Onglyza and suffer from any of these conditions, you might be eligible to file a claim for damages. Additionally, if you have a family member who took Onglyza and died from one of these conditions, you might be eligible for compensation.
If successful, your claim may allow you to recover damages such as:
- Medical costs
- Lost earning potential and wages
- Pain and suffering
Some plaintiffs are seeking punitive damages from the manufacturer, which aim to punish the defendant and discourage future similar behavior. Punitive damages are recoverable in cases of gross negligence, which some allege is the case with AstraZeneca’s failure to property test Onglyza to identify complications like heart failure.
To learn more about your right to file a claim, speak with a lawyer. Call 1-800-DRUG-411 for help finding a lawyer who can answer your questions and help you file a claim against the manufacturer for your damages.