If you have received treatment for Type 2 diabetes, there’s a good chance your doctor has prescribed you a medication called Kombiglyze. Kombiglyze is a combination of two different drugs, saxagliptin and metformin. This combination has only been offered for a few short years, but already it has led to widespread concern among doctors and patients, and triggered a warning from the FDA. It now appears that Kombiglyze may cause pancreatitis, cancer or pre-cancerous tumors, heart failure and even death.
If you have taken Kombiglyze and experienced health complications, or if anyone close to you has, you should contact our attorneys immediately for a free consultation. You are not the only patient who has seen severe health problems after taking this drug. At John Foy & Associates, we have over 20 years of experience handling drug injury cases. Call us at 404-400-4000 and get your free consultation today.
What is Kombiglyze?
Kombiglyze is what’s known as an incretin mimetic drug. That means it imitates incretins, a type of natural gut hormone that the body releases whenever you eat food. Incretins play many roles in the body, but one important job is to trigger the production of insulin to help your body absorb blood sugar (glucose) from your meal. People with Type 2 diabetes cannot efficiently use the insulin their bodies produce, so the extra insulin production helps them keep their blood sugar levels stable.
By simulating incretin, Kombiglyze can be highly effective for diabetics. However, it runs into the same problems that we have seen with one diabetes drug after another: imitating hormones, or forcing the body to over-produce insulin, can take a tremendous toll on the body and lead to serious health complications. This appears to be particularly true with Kombiglyze, which has now been linked to some of the most serious problems caused by diabetes drugs:
- Heart failure
- Pancreatitis (inflammation in the pancreas)
- Pancreatic cancer
- Thyroid cancer
- Kidney disease
Any of these conditions can be fatal, and it is possible that Kombiglyze is putting patients’ lives at risk.
Why is Kombiglyze so dangerous?
The full extent of the risks of Kombiglyze are not yet known. It has only been on the market since 2010, but it is made of two constituent drugs that both carry health risks of their own:
- Saxagliptin, sold under the brand name Onglyza, is implicated in numerous lawsuits. It has been linked to respiratory infection, dangerously low blood sugar, and congestive heart failure. In fact, according to a 2013 study published in the New England Journal of Medicine, patients on Onglyza have a 27% higher risk of heart failure.
- Metformin, the other key ingredient of Kombiglyze, has been around much longer and is a widely accepted drug. However, like all diabetes drugs it has its own pros and cons and other Metformin combinations have been shown to be particularly dangerous.
Does Kombiglyze cause heart failure?
The FDA is currently investigating a possible link between Kombiglyze and heart failure. This link seems likely because saxagliptin, one of the two active ingredients in Kombiglyze, has already been shown to correlate with a higher risk of heart failure. Regulators have issued a public safety communication stating that they have requested more data from AstraZeneca, the maker of both drugs. Unfortunately it could take years of additional research to gather this information. Every patient who experiences heart failure in the meantime has a right to come forward and make a claim.
What is the link between Kombiglyze and cancer?
There is increasing concern over a possible link with cancer. In fact, experts have urged caution about the entire class of incretin mimetic drugs that Kombiglyze belongs to. In the Journal Diabetes Care, researchers argued that there has been far too much enthusiasm for these drugs when too little safety data is available. Specifically, the researchers said:
“Of perhaps greatest concern… is preliminary evidence to suggest the potential risks of asymptomatic chronic pancreatitis and, with time, pancreatic cancer.”
There is preliminary evidence to back up this concern. It has long been known that saxagliptin is linked with higher risk of pancreatitis, and pancreatitis itself can lead to pancreatic cancer. Indeed, researchers have found pre-cancerous growths in tissue samples from the pancreases of diabetes patients who used incretin mimetics. Tragically, these tissue samples were taken from patients who had died for seemingly unknown reasons. The FDA is now officially investigating this link.
Pancreatic cancer is not the only kind of cancer that may be linked to Kombiglyze. The FDA is also investigating another drug, Victoza, which has been found to cause malignant thyroid tumors. Victoza is in the same family of drugs and works very similarly to Kombiglyze, raising concern for Kombiglyze patients.
Who is liable for harm caused by Kombiglyze?
Kombiglyze is manufactured by a pharmaceutical company called AstraZeneca. The law says that drug manufacturers like AstraZeneca are responsible for any harm their products cause, if doctors and patients were not warned about the risk. At John Foy & Associates, it is our belief that doctors would not have prescribed Kombiglyze so widely if they had been properly warned that it may cause heart failure, cancer or pre-cancerous growths. We believe that many, perhaps even millions of individual patients have been put at unnecessary risk.
How do I know if I have a Kombiglyze claim? What costs can I recover?
The only way to know if you have a claim is to speak to a legal professional. That’s why we offer a free, in-depth consultation to go over your case. Anyone who suffered heart failure, pancreatitis, pancreatic cancer, kidney disease or thyroid cancer after taking Kombiglyze may have a claim.
Patients who have been harmed by Kombiglyze, or their families, may be eligible to recover all of their costs, including:
- Medical bills and the cost of medication
- Costs of ongoing care or rehabilitation
- Lost wages or missed work time due to your condition
- Additional money to offset pain, suffering, trauma or the loss of a loved one
No financial award, no matter how big, can ever undo a serious medical condition or bring back a loved one. But this money can help you and your family avoid a lifetime of medical debt for an injury that wasn’t your fault. We urge you to speak to a lawyer.
John Foy & Associates can help. We have the experience, knowledge and expertise necessary to take on a major pharmaceutical company and win—and we charge nothing unless we get you a financial recovery. Call 404-400-4000 and get your FREE consultation today.