As treatment for type 2 diabetes, Onglyza and Kombiglyze lower blood sugar along with changes in lifestyle like eating a better diet and exercising more. Onglyza is the generic medication saxagliptin, while Kombiglize is a combination of saxagliptin and metformin. These two drugs were created, produced, and are manufactured jointly by AstraZeneca and Bristol Myers Squibb.
Although these drugs have been found to be effective in controlling blood sugar in adults with type 2 diabetes, they have also been found to increase the risk of developing certain serious conditions. These include pancreatitis, heart failure, and a life-threatening condition called lactic acidosis. Patients using these medications may even be at risk for certain types of cancer. Lawsuits have been filed against the drug companies and you may choose to be a part of the fight against them to win monetary damages if you were harmed by these drugs.
What Are Onglyza and Kombiglyze?
Onglyza was created and developed by AstraZeneca and Bristol Myers Squibb to treat type 2 diabetes. The generic name of this drug is saxagliptin and it was approved for use in adults by the U.S. Food and Drug Administration (FDA) in 2009. The FDA then approved Kombiglyze, which is a combination of saxagliptin and metformin, in 2010. The combination of the newer medication with metformin is designed to give patients extra control over blood sugar.
How They Treat Type 2 Diabetes
Type 2 diabetes is not the same as type 1 diabetes. Onglyza and Kombiglyze are only indicated for the treatment of type 2 diabetes in adults. This condition is characterized by chronically high blood glucose, or blood sugar, levels. This happens when something goes wrong with insulin, the hormone that is excreted by the pancreas to lower the level of sugar in the blood. Either the body has become less sensitive to insulin or the pancreas is not producing enough.
Without treatment, type 2 diabetes can lead to serious complications including heart disease, permanent nerve damage, eye damage, and even blindness and eventually death. With changes in diet and exercise, and with a medication that controls blood sugar, people with type 2 diabetes can avoid these complications and even reverse the course of the disease.
Saxagliptin is a member of a class of drugs called DPP-4 inhibitors. DPP-4 is an enzyme that breaks down the hormones needed to control blood sugar levels. By inhibiting this enzyme, saxagliptin has the effect of increasing the amount of hormones. This in turn leads to an increase in insulin, especially after eating, and a reduction in the amount of glucose produced in the liver. The metformin in Kombiglyze adds to these effects. As a biguanide drug it acts to decrease the amount of glucose absorbed by food and made in the liver.
The most-often reported side effects from Onaglyze include upper respiratory infections, along with cold-like symptoms like congestion and sore throat. Also common are urinary tract infections, joint pain, and headaches. Because it contains metformin, Kombiglyze may also cause gastrointestinal side effects like constipation, gas, or diarrhea, as well as muscle pain, flushing, and heartburn.
DPP-4 inhibitors like Onglyza have been shown to increase the risk of developing pancreatitis and pancreatic cancer. Acute pancreatitis is particularly dangerous because it develops quickly and can be fatal if not treated right away. Signs of pancreatitis include pain in the abdomen that may wrap around to the back. This pain usually intensifies after eating and only gets worse with time. It may be accompanied by nausea and vomiting.
Also troubling is that saxagliptin may cause cancer cells to form in the pancreas. One study found pre-cancerous cells in the pancreases of several deceased people who had been taking Onglyza. Saxagliptin increases the number of cells in the pancreas that produce insulin, but the researchers found that these newly-created cells were often abnormal and showed signs of developing into tumors. These same results were not seen in type 2 diabetes patients taking certain other medications. The FDA has not issued a warning about pancreatic cancer, citing not enough evidence.
In 2014 the FDA issued a warning that there may be an increased risk of developing or having worsening congestive heart failure from taking Onglyza or Kombiglyze. This warning came after a study found that taking these drugs increased the number of hospitalizations for heart failure. The problem is that DPP-4 inhibitors cause fluid retention, which causes edema, or swelling. This impacts the heart and can make it more difficult for the heart to pump bloods. When the heart cannot pump bloods as well as it should, it is called congestive heart failure.
Because of these risks, the FDA issued a warning to doctors and patients and recommended that patients talk to their doctors about whether or not they should be taking Onglyza or Kombiglyze. Patients who already have congestive heart failure or who have other risk factors for it may need to reconsider using these medications.
Metformin, one of the drugs in Kombiglyze, is also known to put patients at risk for lactic acidosis. This is a dangerous condition in which lactic acid builds up in the blood. Lactic acidosis is life-threatening and is considered a medical emergency. Those patients taking Kombiglyze are at additional risk if they also drink a lot of alcohol, have an infection, are dehydrated, have liver or kidney damage, or are having surgery or being injected with dye for X-rays.
Signs of lactic acidosis should be recognized early and treated immediately, otherwise this can be fatal. Signs are weakness, fatigue, muscle pain, sleepiness, nausea, vomiting, or diarrhea, a cold feeling in the limbs, lightheadedness, difficulty breathing, and a slow or irregular heartbeat.
Many lawsuits have been filed against companies that have produced these newer type 2 diabetes drugs that are causing serious conditions like pancreatitis and cancer. Onglyza has been targeted specifically, namely in one lawsuit brought by an individual whose mother died from heart failure after taking the medication. How these lawsuits will turn out remains to be seen, but if plaintiffs can show that AstraZeneca and Bristol Myers Squibb new about some of these risks and misrepresented them, the victims may be seeing monetary damages.
If you have suffered from pancreatitis, heart failure, cancer, lactic acidosis, or any of the other serious conditions associated with Onglyza or Kombiglyze, you may want to contact a lawyer to help you put together a suit. To get money damages won’t turn back the clock and prevent you from getting sick, but it can go a long way toward getting you back on your feet.