Onglyza and Kombiglyze XR Linked to Serious Side-Effects

After Onglyza and Kombiglyze XR were released onto the market in 2009 and 2010 (respectively), researchers hailed the new drugs as the next major innovation in diabetes treatment after the invention of insulin a century prior. However it needs to be stressed that DPP-4 inhibitors may be linked to some pretty nasty side-effects.

How the Drugs Work

Both drugs use saxagliptin as their active ingredient. Saxagliptin is a DPP-4 inhibitor, which means it reduces the generation of an enzyme known as DPP-4. That enzyme is meant to break down GLP-1 – a hormone released into the body after the ingestion of food – in order to promote the production of insulin in the pancreas. Thus, by inhibiting the creation of DPP-4, GLP-1 is allowed to flourish, encouraging the production of more insulin in the type 2 diabetes patient. This is important since type 2 diabetes patients suffer from a deficit of insulin, which is required to regulate the generation of (glucose) sugar in the body and thereby control blood-sugar levels.

Side Effects

However, Onglyza and Kombiglyze XR – and other DPP-4 inhibitors – have been linked to health issues like heart failure, pancreatitis and severe joint pain. Pancreatitis and heart failure are of particular concern, since they can sometimes lead to death. It should also be noted that Kombiglyze XR mixes saxagliptin with metformin in a long-release capsule, so this drug may lead to its own particular set of side effects, including:

• Upper respiratory tract infection
• Sore throat
• Vomiting
• Diarrhea
• Stomach pain
• Headache

Those are just a few of the potential side-effects of Kombiglyze XR, so be sure to ask your doctor about the risks before taking this drug.

FDA

Onglyza and Kombiglyze XR, manufactured by Bristol-Myers Squibb and AstraZeneca, were approved by the FDA in 2009 and 2010, respectively. That was well before the FDA issued a notice in 2016 warning consumers of an increased risk of heart failure or kidney disease. According to the notice, “Patients taking these medicines should contact their health care professionals right away” if they notice any of the following issues:

• shortness of breath
• breathing issues when lying down
• fatigue or weakness
• swelling or weight gain

Studies

The FDA referenced two major studies pertaining to the adverse effects of saxagliptin and alogliptin (used in other similar drugs). In one of those studies, published in The New England Journal of Medicine, 3.5 percent of those taking saxagliptin were hospitalized for heart failure – compared to 2.8 percent of patients taking placebos. Patients with a history of heart failure or kidney impairment are more susceptible to these extreme side-effects. The study followed 16,492 type 2 diabetes patients over the course of 2.1 years. The patients all had some history of “or were at risk for cardiovascular events.”

Side Effects Explained

Heart failure happens when the heart can no longer pump blood, and it is usually linked to high blood pressure or disease in the coronary artery. Patients who suffer from this affliction would do well to radically change their lifestyle by increasing their exercise, decreasing stress level and developing a healthier diet. This may require the input of a seasoned health professional or nutritionist.

Similarly, pancreatitis, or inflammation of the pancreas, is a very serious condition that could lead to pancreas cancer or even death. According to the FDA, doctors who suspect that a patient is at risk of pancreatitis should stop prescribing Onglyza and Kombiglyze XR immediately.

Finally, anyone taking a drug with saxagliptin should not rely solely on the drug. According to researchers, “Although saxagliptin improves glycemic control, other approaches are necessary to reduce cardiovascular risk in patients with diabetes.” Generally speaking, these drugs are prescribed in combination with an exercise regimen. Be sure to have a thorough conversation with your physician about the risks of these drugs.

Compensation

So far, a few lawsuits have been filed, alleging that these drugs can cause injury to the heart. Though no settlements or verdicts have been announced, there may be a chance for those who have suffered at the hands of saxagliptin to obtain compensation for expenses associated with their injuries. If you have been injured after taking Onglyza and Kombiglyze XR, you may want to contact a defective medication attorney who is familiar with the drugs in question.