Type 2 diabetes is often treated with a combination of medication and lifestyle changes. One of the newest drugs used for this condition is called Glyxambi, made by Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Co. The U.S. Food and Drug Administration approved Glyxambi for use in treating type 2 diabetes in 2015. It is the first drug in a new class that combines two previous medications.

As a combination of two medications, Glyxambi is supposed to give patients better control over blood glucose levels. However, the drug does come with some serious risks, which may lead to lawsuits in the future. These risks include pancreatitis and pancreatic cancer. It remains to be seen with more long-term use of this new drug, if there will be other issues and safety concerns.

What is Glyxambi?

Glyxambi is a new medication, the first of its kind to combine two previously used drugs to make one more effective treatment for type 2 diabetes. The two drugs combined in Glyxambi are empagliflozin, brand name Jardiance, and linagliptin, brand name Tradjenta. Both medications are products of Boehringer Ingelheim and Eli Lilly and were approved by the FDA in 2011 and 2014.

Both drugs, and together as Glyxambi, are used to treat type 2 diabetes, a condition in which blood glucose levels get too high because of a lack of sensitivity to the hormone insulin. The pancreas excretes insulin in response to high blood sugar levels. In a person with type 2 diabetes, the body doesn’t react normally to insulin or doesn’t produce enough insulin and blood sugar levels remain too high, which can lead to serious complications. Medications like Glyxambi lower the level of glucose in the blood, but making lifestyle changes like losing weight, eating a healthy diet, and exercising also help get blood glucose levels under control.

How it Works

Each of the two drugs in Glyxambi works in a unique to control blood sugar. This combination is hoped to be more effective at maintaining healthy glucose levels because it attacks the problem in two different ways. Linagliptin belongs to a class of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors. DPP-4 is an enzyme that breaks down hormones responsible for insulin secretion. By inhibiting this enzyme, linagliptin promotes a greater release of insulin, which brings down blood sugar levels.

Empagliflozin is a sodium glucose cotransporter-2 (SGLT-2) inhibitor. SGLT-2 is a protein found in the kidneys and is responsible for filtering glucose out of urine and sending it back into the bloodstream. Empagliflozin acts to inhibit this process so that this excess glucose is secreted in the urine and not reabsorbed into the blood. Together these two medications work on lowering glucose levels on two totally separate fronts. Separately they have been found to be effective at lowering blood sugar, so together they are even more effective.

Side Effects

The most common side effects of Glyxambi are infections. These may be urinary tract infections, yeast infections, upper respiratory tract infections, or nasopharyngitis. If you experience an infection, you need to tell your doctor so you can be treated for it. Other possible side effects include raised cholesterol levels, dehydration and hypoglycemia. Hypoglycemia is dangerously low blood sugar. Signs of this include drowsiness, weakness, confusion, hunger, headaches, a fast heart rate, irritability, sweating, and jitteriness.

Allergic reactions may also be possible with Glyxambi and can be very serious. Signs of an allergic reaction include swelling in the face and mouth, skin rashes, itching, and hives, peeling or flaking skin, and difficulty breathing or swallowing. These symptoms should be treated immediately as an allergic reaction can be life-threatening.

Pancreatitis and Pancreatic Cancer

Because the two drugs that make up Glyxambi were already on the market and tested, there are some known risks of taking this combination drug that are not common, but very serious. One of these is an increased risk of pancreatitis, an inflammation of the pancreas, and pancreatic cancer, both of which may be life-threatening. Linagliptin, in particular, has been reported to cause acute and fatal cases of pancreatitis.

Patients who have previously had pancreatitis, had gallstones, have had high blood triglyceride levels, or who have a history of alcohol abuse are especially at risk for developing pancreatitis while on Glyxambi. If you take this medication, you should be aware of the signs of acute pancreatitis, and get medical help right away if you experience them. They include severe abdominal and back pain that won’t go away, either with or without vomiting.

In 2013 the FDA reported that it would investigate the increased number of pancreatitis and pancreatic cancer in patients taking linagliptin. The investigation as triggered by unpublished academic research that found a connection between the pancreatic damage and patients who died while taking linagliptin and other type 2 diabetes drugs. If the drug companies are found to have known about the risks earlier, they could face serious fines and settlements in lawsuits.

Diabetic Ketoacidosis

Patients taking empagliflozin have reported cases of ketoacidosis, another serious and life-threatening condition that requires immediate medical treatment. It is caused by a lack of glucose, which causes the body to burn fat for energy. This causes a buildup of ketones in the blood, which makes it acidic. If not treated, this can be fatal. Watch for early signs of ketoacidosis, which include dry mouth and thirst, frequent urination, and high blood sugar levels. Later signs include fatigue, dry and flushed skin, nausea, vomiting, abdominal pain, fruity breath, confusion, and trouble breathing.

Kidney Failure

Kidney problems may be triggered by Glyxambi, especially in anyone who already has kidney disease or damage or in patients 75 years old and older. Glyxambi is not supposed to be used in patients with severe kidney problems or who are on dialysis. Empaglifozin is the component that can lead to kidney damage because of how it acts on SGLT-2 in the kidneys.

Lawsuits

Glyxambi is still a new drug, but lawsuits may eventually be filed if patients feel they were not adequately warned of the risks of taking the medication and then suffer serious side effects. Suits have already been filed against Boehringer Ingelheim and Eli Lilly because of damage caused by Jardiance (empagliflozin) and Tradjenta (linagliptin). Tradjenta, in particular, has been the subject of lawsuits because of the patients who have suffered pancreatitis and pancreatic cancer after taking it. Glyxambi may suffer the same consequences if more patients develop these conditions.  

If you have taken Glyxambi and are concerned about its safety, talk to your doctor about the risks. If you have already suffered some of these serious side effects, you may have a case against the drug companies. A lawyer can help you decide what steps to take next. Compensation from a lawsuit or settlement could help you pay your medical bills and restore any lost income from not being able to go to work.