Onglyza (saxagliptin), a prescription drug used to treat type-2 diabetes, has been linked to heart failure and other serious, and potentially fatal, side effects.

In April 2015, the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted by an overwhelming majority to update the warning label accompanying packages of Onglyza.

After reviewing two clinical studies, the FDA concluded that patients taking SGLT-2 inhibitor drugs in this class were 27% more likely to experience heart failure requiring hospitalization. Onglyza patients were also found to have a greater overall risk of death.

Injury lawsuits against drug manufacturers claim that Onglyza and similar medications were inadequately tested as to whether its mechanism of action would have an impact on the cardiovascular system.

About Onglyza

Onglyza (also known by the generic name saxagliptin) is a member of a class of type 2 diabetes medications known as dipeptidyl peptidase-4 inhibitors. or DPP-4 inhibitors. In simple terms, these drugs manipulate hormone levels and balances in such a way that stimulates the pancreas to secrete greater amounts of insulin. It accomplishes this by disabling the action of the protein identified as DPP-4.

When DDP-4 cannot do its job, it leads to an increase in levels of hormones known as incretins. Greater incretin levels prevent the production of a second hormone, known as glucagon, which is produced by the pancreas and normally causes blood sugar levels to rise. In the absence of glucagon, the pancreas instead releases higher amounts of insulin.

Saxagliptin-based drugs like Onglyza are used to help control diabetes, along with exercising and maintaining a healthy diet. These drugs work to target and regulate the blood sugar levels of patients by stimulating pancreatic insulin production. Other saxagliptin medications include Kombiglyze XR, Qtern, and Qternmet.

Onglyza is manufactured jointly by pharmaceutical giants Bristol-Myers Squibb and AstraZeneca (which also jointly developed Kombiglyze XR, a combination of saxagliptin and metformin) and was approved by the FDA in July of 2009. Within three years, the diabetes medication accounted for over $700 million in annual sales revenue, according to FDA reports. This rapid increase in popularity is in part due to the recall of another major diabetes drug, Avandia, after it was linked with an increased risk of cardiac death.

Like any medication, Onglyza comes with certain potential side effects, such as headache, runny or stuffy nose, sore throat, cough, mild nausea, and bloating, among others. According to the FDA’s initial approval documents, headaches were the most common adverse reactions which occurred more commonly in Onglyza patients opposed to placebo patients.

Unfortunately, saxagliptin-based drugs like Onglyza have also been linked with a number of serious and even life-threatening complications—and some patients claim that they were not adequately warned about this risk.

Heart Failure and Stroke Risk

The FDA has warned about the risk of heart failure associated with the use of saxagliptin-based type-2 diabetes drugs like Onglyza. This increased risk is particularly heightened in those who already have heart or kidney disease, the federal agency warned.

After taking one of these type-2 diabetes drugs, there are a number of signs of heart failure that patients can look out for. These include:

• Unusual shortness of breath during daily activities
• Trouble breathing when lying down
• Tiredness, weakness, or fatigue
• Weight gain with swelling in the ankles, feet, legs, or stomach

If you suspect that you may be suffering from heart failure or other serious Onglyza side effects, contact your medical professional immediately.

The danger of heart failure is only the most recent harmful side effect to be associated with Onglyza and similar medications. The 2014 FDA safety review was performed less than six months after a study in the New England Journal of Medicine found a significant increase in heart-related hospitalizations among Onglyza patients as compared to those who took a placebo. The study, known as the SAVOR study, looked at more than 16,000 type-2 diabetes patients on Onglyza and comparable drugs.

In response to this study, the FDA conducted its own safety review and released a safety communication about the risk. “A safety review has found that type 2 diabetes medications containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease,” the federal agency warned.

Filing an Onglyza Lawsuit

A growing number of patients are coming forward with allegations of serious complications such as heart failure and more. Patients claim that they were not adequately warned about Onglyza’s more serious health risks.

If you or someone you love has suffered or even died from Onglyza side effects like heart failure, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot take away the pain and suffering caused by these complications, nor can it bring a loved one back to life. However, a successful lawsuit can at least help to alleviate the financial burden experienced by medical expenses and lost wages.

Filing a lawsuit can be a daunting prospect, especially while also dealing with serious health issues, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.