By Paul Tassin  |  March 25, 2016

Category: Legal News

Onglyza side effectsManaging diabetes with Onglyza offers certain benefits, like improving blood sugar control without triggering weight gain. At the same time, Onglyza comes with the risk of certain side effects that patients may want to be aware of.

Onglyza is a brand name that refers to the generic drug saxagliptin. Saxagliptin is also used in the brand-name drug Kombiglyze, which combines it with the older diabetes medication metformin.

Both Onglyza and Kombiglyze are approved for diabetes management in combination with diet and exercise. They are also both members of a class of diabetes medications known as DPP-4 inhibitors.

Diabetes Management With DPP-4 Inhibitors

Also known as gliptins, DPP-4 inhibitors are a relatively new class of diabetes medications, having been first approved by the FDA in 2006.

These diabetes management drugs help keep excessive blood sugar levels under control by affecting the way the body responds to meals. When a person eats, their body releases a type of hormone known as incretins.

Incretins lower blood sugar levels in two particular ways. First, they stimulate the release of insulin, which triggers the body to remove sugar from the blood. Second, incretins inhibit the pancreas from releasing glucagon, a hormone that causes blood sugar levels to rise.

DPP-4 is a naturally-occurring enzyme that removes incretins from the body. In healthy persons, this process is normal. Persons managing diabetes, however, can benefit from prolonging the action of incretin hormones.

And that’s what DPP-4 inhibitors like Onglyza and Kombiglyze do. These drugs prevent DPP-4 from removing incretin hormones, allowing them to continue keeping blood sugar levels lower than they would be otherwise. Kombiglyze can offer an even broader spectrum of diabetes management by combining the effect of saxagliptin with the different mechanism of action used by metformin.

Side Effects of DPP-4 Inhibitors

Like a lot of drugs, Onglyza and Kombiglyze may cause certain side effects. The more common side effects of Onglyza include headaches, skin rashes, swelling of the face, and infections of the urinary tract or upper respiratory tract.

Other possible side effects from these diabetes managing drugs, though not as common, can be much more serious. In April 2015, a panel of FDA experts recommended adding a warning to the label for Onglyza addressing a possible risk of heart failure.

The panel based their recommendation on the results of two studies, the SAVOR-TIMI 53 study and the EXAMINE study. Panelists noted a 27 percent increase in first-time hospitalizations for heart failure, which they felt was significant enough to warrant an update to the diabetes drug’s warning label.

Some studies have also suggested a possible link between Onglyza and certain pancreatic conditions, including pancreatic cancer. In one study from 2013, researchers found precancerous cells in the pancreases of patients who had taken incretin-based medications. They also found some small tumors called adenomas that could possibly have become malignant.

Pancreatitis is another possible side effect of Onglyza, one that may in some cases be a precursor to pancreatic cancer. In November 2011, the FDA added a warning to Onglyza’s label about reports of pancreatitis associated with Onglyza diabetes management.

In general, Onglyza lawsuits are filed individually by each plaintiff and are not class actions.

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