An increased risk of heart failure and saxagliptin has been linked in recent studies of the popular diabetes medication.

The FDA approved Onglyza (saxagliptin) in 2009 to help patients with type 2 diabetes bring their blood sugar under control. Kombiglyze combines saxagliptin and metformin. Both Onglyza and Kombiglyze are made by AstraZeneca.

Both medications belong to a class of drugs called incretin mimetics that stimulate the pancreas to produce insulin. This relatively new class of diabetes medications became known with the onset of Avandia, which was recalled upon being linked to a marked increase in the risk of heart-related death.

Now it appears that Onglyza and Kombiglyze are headed down a familiar road with a potential link between heart failure and saxagliptin, which the FDA announced through a safety communication issued in February 2014.

In April 2015, the FDA Endocrinologic and Metabolic Drugs Advisory Committee examined two large clinical trials of patients suffering from heart disease.

Both trials proved a higher number of patients who received saxagliptin were hospitalized for heart failure compared with a control group who received a placebo. The numbers mean 35 out of every 1,000 saxagliptin patients developed heart problems, compared with 28 of every 1,000 patients who took the placebo.

Impaired kidney function was related to an increase in the incidence of heart failure.

The study led to the FDA adding new Warnings and Precautions regarding the increased risk of heart failure to the list of possible saxagliptin side effects.

Heart Failure and Saxagliptin Link Found in 2013

A study done in 2013 to find out if saxagliptin provided any benefits to heart health surprised researchers who determined Onglyza patients showed an increased risk for heart failure.

Bristol-Myers Squibb and AstraZeneca funded their own study that found patients who took saxaglipin had an increased number of hospital admissions due to heart failure.

Heart failure is a result of the heart pumping blood at an abnormally slow pace because the heart muscle has weakened.  As a result, the body’s organs and cells don’t receive adequate amounts of oxygen and nutrients. Fluid retention eventually leads to congestive heart failure.

Signs of heart failure and saxagliptin include:

• Marked shortness of breath during daily activities
• Breathing problems upon lying down
• Tiredness, weakness, or extreme fatigue
• Gaining weight and swelling of the ankles, feet, legs or stomach
• Rapid or irregular heartbeat
• Nagging cough or wheezing with white or pink blood-colored phlegm
• Increased need to urinate in the night
• Lack of appetite, nausea
• Reduced ability to exercise

Patients with type-2 diabetes who have a history of heart failure, pancreatitis, gallstones, high triglyceride levels or a history of alcoholism should share this information with their doctors before starting on Onglyza or Kombilglyze.

If you have taken either Onglyza or Kombiglyze and believe you have suffered from heart failure and saxagliptin ill effects, you could benefit from speaking with an attorney regarding your options for legal recourse.