Increased Saxagliptin Heart Failure Risk Possible in Onglyza, Kombiglyze XR Patients

Patients taking type-2 diabetes medications Onglyza or Kombiglyze XR might experience an increased saxagliptin heart failure risk.

Researchers indicate patients who take either of these medications might also be at an increased risk of hospitalization because of heart failure. Patients who may have suffered complications or injury may be able to join an Onglyza class action lawsuit.

Onglyza only contains saxagliptin as its active ingredient, and Kombiglyze XR contains both saxagliptin and metformin hydrochloride. Jointly manufactured by pharmaceutical giants Bristol-Myers Squibb and AstraZeneca, and FDA-approved in July 2009 and November 2010 respectively, the diabetes medications are used to help control blood sugar levels in adults who have been diagnosed with type-2 diabetes. Type-2 diabetes is a condition that prevents bodies from producing the hormone insulin properly. The drugs are meant to be used along with diet and exercise.

Both Onglyza and Kombiglyze XR belong to a relatively new class of drugs called incretin mimetics which work by stimulating the pancreas to produce insulin for blood sugar regulation.

Drugs in this class have become popular very recently, after the recall of another major diabetes drug. Avandia was the first incretin mimetic on the market, but was recalled after the type-2 diabetes medication was linked to an increased risk of cardiac death. Knowing this, the saxagliptin heart failure risk is not such a surprise.

Overview: Heart Failure

Heart failure occurs whenever the heart is unable to pump blood sufficiently. In some cases, this is caused when the heart is so weak that it pumps too slowly. Heart failure could also be caused by the heart being unable to fully fill with blood — impairing its ability to circulate blood properly. In general, heart failure is dangerous because it causes the body to lack oxygen and nutrients.

Symptoms of heart failure include:

• Shortness of breath during daily activities
• Breathing problems upon lying down
• Extreme fatigue
• Rapid or irregular heartbeat

In some cases, patients may also experience:

• Nagging cough or wheezing
• Reduced appetite
• Swollen feet and ankles

High blood pressure and coronary artery disease are chronic conditions which can weaken the heart and lead to heart failure. Patients diagnosed with heart failure often are advised to lose weight, exercise, improve their diet, reduce salt intake and effectively manage stress. Medications may also be prescribed to manage the condition or treat the underlying cause.

In some cases, when medicine and lifestyle changes are unable to help, surgery may be required. A doctor may recommend a pacemaker, an implantable cardioverter defibrillator (ICD), or a mechanical heart pump.

A last resort surgical treatment may be a heart transplant. Unfortunately, people may be on the heart transplant list for years while waiting for a matching donor – meaning they are only typically used as a life-saving measure for end-stage heart failure.

FDA Announced Saxagliptin Heart Failure Risk

The U.S. Food and Drug Administration (FDA) released an initial safety communication regarding saxagliptin heart failure risk in February 2014.

In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee examined two clinical trials of patients experiencing heart disease.

Both trials found more patients who received saxagliptin were hospitalized for heart failure compared with a control group who received an inert drug (also known as a placebo). The numbers translate to 35 out of 1,000 patients compared with 28 out of 1,000 patients.

Any patient who already suffered from impaired kidney function was more likely to experience an increased saxagliptin heart failure risk.

The study led to the FDA adding new warnings and precautions regarding the saxagliptin heart failure risk listing possible Onglyza adverse effects.

According to the FDA’s announcement, signs of Onglyza heart failure include:

• Unusual shortness of breath
• Trouble breathing while prone
• Tiredness, weakness, or fatigue
• Weight gain and swelling in the ankles, feet, legs, or stomach

Another study that was originally designed with the hope that saxagliptin provided some heart benefits also ended up indicating the medication increased the risk of heart failure and other cardiac problems.

The FDA advisory committee asked the agency to require additional information about Onglyza’s heart failure risk to the drug’s warning label. The FDA updated its safety announcement in April 2016, noting that “a 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.”

Onglyza Label Changes

In 2016, Onglyza updated their safety alert when they added new warnings to the saxagliptin products. These additional warnings help inform consumers that the drugs may increase the risk of heart failure, especially for patients who already struggle with heart disease or kidney disease.

“We urge health care professionals and patients to report side effects involving saxagliptin, alogliptin, or other medicines to the FDA MedWatch program,” the FDA said.

Although the risk of heart failure can be frightening, the FDA urges patients to speak to their doctor before they decide to stop taking the medication. Instead, the agency recommends that patients seek medication attention if they experience heart failure symptoms and disclose any heart failure or kidney problems before starting the drugs.

Another major side effect of Onglyza may be an increased risk of pancreatitis and pancreatic cancer, per a study published in the journal Diabetes Care.

Filing an Onglyza Lawsuit

A growing number of patients are coming forward and filing lawsuits against Bristol-Myers Squibb and AstraZeneca, the joint manufacturers of both Onglyza and Kombiglyze XR, over saxagliptin complications, including heart failure. Patients claim that they were not properly warned about the risks associated with Onglyza or Kombiglyze XR.

If you or someone you love has suffered from heart failure, congestive heart failure, cardiac issues or death after taking saxagliptin-based medications such as Onglyza or Kombiglyze XR, you could be eligible to join a free lawsuit investigation.

Of course, filing a lawsuit cannot take away the pain and suffering caused by these kinds of complications nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden too often incurred in these situations by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, especially while dealing with health complications or the death of a loved one, 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.