Kombiglyze XR, a medication for the treatment of type-2 diabetes, contains saxagliptin and metformin hydrochloride. It is part of a class of medications, like its counterpart Onglyza, known as incretin mimetics.

Bristol-Myers Squibb and AstraZeneca are the pharmaceutical companies responsible for the research, development, and promotion of these drugs.

This is a pretty recent generation of diabetes drugs that attempt to get the patient’s own pancreas to produce insulin and regulate blood sugar levels. Incretin mimetics became popular for a time, but Kombiglyze XR side effects and the side effects of other drugs in this category are currently suspected of contributing to cardiac stress or even heart failure.

The Food and Drug Administration (FDA) approved Onglyza first in July 2009. Approval of Kombiglyze XR followed a little over a year later in November 2010.

On Feb. 11, 2014, the FDA asked for clinical trial data from the maker of saxagliptin after a study published in the New England Journal of Medicine strongly indicated Onglyza and Kombiglyze XR side effects included heart failure or other heart incidents leading to hospitalizations.

Onglyza and Kombiglyze XR Side Effects

The FDA have since added a warning to the label of Kombiglyze XR, alerting patients and their doctors that heart failure may be among Kombiglyze XR side effects.

After a review of the data, a safety announcement was released on April 5, 2016 from the FDA saying that medicines containing saxagliptin and alogliptin could contribute to cardiac events.

The warning was especially amplified to patients already suffering from heart and kidney disease. With this announcement came an addition to the Onglyza and Kombiglyze XR side effects warning section as well as other drugs containing these ingredients.

How These Two Diabetic Medications Work

Sufferers from type-2 diabetes produce less GLP-1, a communicating hormone that ‘tells” the pancreas to release insulin after a person eats. Without enough insulin, sugars build up in the blood, a situation known as hyperglycemia.

The active ingredient in Onglyza and Kombiglyze XR is saxagliptin. Saxagliptin inhibits an enzyme known as DPP-4. The enzyme DPP-4 eliminates GLP-1. By controlling DPP-4, GLP-1 stays in the body, allowing for continued after-meal production of insulin.

Scientists aren’t certain just what problems arise in this process to bring on cardiac issues. These issues arise more often in patients having kidney are heart problems prior to starting treatment with Onglyza or Kombiglyze XR. Indications of this or other very serious Onglyza or Kombiglyze XR side effects may be:

• Swelling of the feet, ankles, and calves.
• Swelling of the hands and lower arms
• Swelling of the throat, face, neck
• Low blood sugar
• Joint pain
• Skin reactions
• Shortness of breath
• Pancreatitis

If you or a loved one have suffered heart or other serious difficulties after taking Onglyza or Kombiglyze XR, you may benefit from a consultation with a knowledgeable products liability lawyer.