Kombiglyze – Emerging Litigation

Kombiglyze XR is a new drug for type-2 diabetes that combines saxagliptin with metformin. Although it has only been on the market since 2010, it has already sparked a warning from the FDA regarding pre-cancerous pancreatic tumors, hospitalization for heart failure, and death.

What is Kombiglyze?
Kombiglyze is a new type of oral drug that is used to help improve blood-sugar control in people with type-2 diabetes. Kombiglyze combines two diabetes drugs: saxagliptin (approved in 2009) and metformin (approved in 1994). Kombiglyze XR is marketed by Bristol-Myers Squibb and AstraZeneca and was approved in 2010.
Kombiglyze is an incretin mimetic drug. This means it works by mimicking incretins (metabolic hormones). Kombiglyze inhibits the enzyme DPP-4, which normally breaks down a hormone called GLP-1. This results in higher levels of GLP-1, which stimulates the pancreas to secrete extra insulin. People with diabetes are resistant to their own insulin. The extra insulin helps reduce blood-sugar levels.

Study Links Kombiglyze and 27% Increased Risk of Heart Failure
In February 2014, the FDA published a Safety Communication and launched an investigation after the New England Journal of Medicine publishes a study linking Kombiglyze and a 27% increased risk of hospitalization for heart failure. Click here to read more.

Does Kombiglyze Cause Cancer?
No one knows whether Kombiglyze causes cancer. However, there are some early warning signs for the entire incretin mimetic class of diabetes drugs, including Kombiglyze. Experts will not know whether Kombiglyze causes cancer until more people take Kombiglyze, get sick, and researchers publish studies.
In the meantime, some experts are recommending caution for the entire incretin mimetic class. In 2010, Diabetes Care published a study of incretin mimetics and cancer with this warning:

“History has taught us that enthusiasm for new classes of drugs, heavily promoted by the pharmaceutical companies that market them, can obscure the caution that should be exercised when the long-term consequences are unknown.”

FDA Warning for Kombiglyze and Cancer Risk
The U.S. Food and Drug Administration (FDA) published a Safety Communication in March 2013 to warn about potential risks associated with Kombiglyze. They were investigating data from researchers who looked at the pancreases of deceased people who were using incretin mimetics. That study found an “increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia.”

Kombiglyze and Pancreatic Cancer
Kombiglyze treats diabetes by stimulating the pancreas to produce more insulin, and in some patients, this may lead topancreatitis (inflammation of the pancreas that can be chronic or acute). Pancreatitis is a major risk-factor for pancreatic cancer, due to cellular DNA mutations that can occur due to increased cell turnover. Studies of animals given incretin mimetic drugs have found evidence of silent, low-level chronic pancreatitis.

Kombiglyze and Thyroid Cancer
The link between Kombiglyze and thyroid cancer will likely be under investigation for many years, because thyroid cancer is a very rare disease. However, the FDA has already issued a Safety Communication about the link between Victoza (liraglutide) and thyroid cancer after the drug was found to cause malignant thyroid tumors at dosages that were clinically relevant for humans. Victoza and Kombigylze both belong to the same class of drugs and treat diabetes in a similar way, which raises concern about a potential link between Kombiglyze and thyroid cancer.

Kombiglyze Class Action
Our lawyers are not filing a Kombiglyze class action against AstraZeneca. Instead, we are filing individual lawsuits on behalf of people who were severely injured by side effects, such as:
• Hospitalization for heart failure
• Pancreatitis (inflammation in the pancreas)
• Thyroid cancer
• Pancreatic cancer
• Kidney disease
• Death