About Onglyza

People with type 2 diabetes generally have a higher risk of experiencing cardiovascular problems like heart attack and heart disease due to common diabetes-related complications like high cholesterol, obesity and high blood pressure. Diabetes drugs like Onglyza are often prescribed to type 2 diabetes patients to help keep their blood glucose levels under control, which can lower these cardiovascular risks. However, research has shown that many popular type 2 diabetes drugs, Onglyza included, may actually increase the risk of congestive heart failure, a type of heart disease, and other cardiovascular problems in users. Heart disease, which encompasses a wide range of heart problems, is the leading cause of death for men and women in the United States. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 655,000 Americans die from heart disease every year.

What is Onglyza?

Onglyza (saxagliptin) belongs to a class of diabetes drugs called dipeptidyl peptidase-4 (DDP-4) inhibitors, also known as incretin mimetics. These medications are designed to be used in combination with diet and exercise to lower blood sugar levels in adults with type 2 diabetes. Onglyza does this by increasing the amount of insulin released by the pancreas, which can help keep glucose levels within the normal range. Onglyza is made and sold by AstraZeneca and Bristol-Myers Squibb and the drug has been on the market in the United States since 2009, when it was approved by the FDA for the treatment of type 2 diabetes. While some people have had success treating their diabetes with Onglyza, others have experienced congestive heart failure and other potentially life-threatening cardiovascular problems after using the drug.

Heart Failure Linked to Onglyza

Congestive heart failure is a chronic, progressive condition in which the heart muscle does not pump blood well enough to meet the body’s needs. A healthy heart continuously pumps blood to all parts of the body, making sure it gets the blood and oxygen it needs to function properly. In people with congestive heart failure, the flow of blood slows down as it leaves the heart and as it returns, which can cause blood to back up in the veins. This can result in kidney damage, kidney failure, heart valve problems, heart rhythm problems and liver damage, among other serious complications. In addition to a possible increased risk of congestive heart failure, research has found that diabetes patients taking Onglyza may also be more likely to develop pancreatitis and pancreatic cancer.

FDA Warnings About Possible Onglyza Side Effects

In February 2014, the FDA issued a drug safety communication explaining the agency’s plan to review the potential risk of heart failure associated with saxagliptin (Onglyza). In the safety announcement, the FDA reported that it had requested clinical trial data from the manufacturer of saxagliptin, “to investigate a possible association between use of the type 2 diabetes drug and heart failure.” The FDA’s request came on the heels of a study published in the New England Journal of Medicine, which found a 27% increased rate of hospitalization for heart failure among patients taking Onglyza, compared to an inactive treatment.

Due to growing concerns about the possibility of patients taking Onglyza facing a greater risk of heart failure, an FDA advisory committee recommended in 2015 that the Onglyza drug label include clear warnings about this serious health risk. This recommendation was based on the results of the SAVOR clinical trial, which showed that Onglyza treatment was associated with a significantly increased risk of heart failure. Of the 15 advisory panel members, 14 recommended that the FDA add new safety information to the Onglyza label regarding the increased risk of heart failure. The remaining panel member voted to remove Onglyza from the market altogether due to safety concerns.

The following year, the FDA issued new information about the Onglyza heart failure risk originally highlighted in the agency’s 2014 safety announcement. According to the updated drug safety communication, “A U.S. Food and Drug Administration (FDA) safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.” As a result of this safety issue, the FDA added new heart failure warnings to the Onglyza label.

Heart Failure Sufferers Pursuing Onglyza Injury Lawsuits

Type 2 diabetes patients who have suffered congestive heart failure or were hospitalized for cardiovascular problems during or after Onglyza treatment are pursuing legal claims against manufacturers AstraZeneca and Bristol-Myers Squibb, seeking compensation for their medical care, lost wages, pain and suffering, and other damages. These product liability lawsuits allege that the drug makers manufactured a dangerous medication, improperly marketed the drug to diabetes patients despite the known safety risks, and failed to ensure that users were adequately warned about the potential heart-related side effects associated with the diabetes medication. As of December 2020, more than 250 lawsuits are pending in state and federal courts nationwide over injuries from Onglyza and Kombiglyze XR a saxagliptin and metformin extended-release medication.