Kazano is a new diabetes drug that works by influencing hormones that regulate blood-sugar levels. The FDA is investigating long-term side effects like pancreatitis and pancreatic cancer. The label has been updated to warn that Kazano may increase the risk of heart failure.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Kazano induced injury cases in all 50 states. If you or somebody you know was diagnosed with pancreatic cancer or heart failure, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
Kazano and Heart Failure
April 5, 2016 — The FDA is warning that Kazano increases the risk of heart failure, especially for patients who already have heart disease or kidney problems. The warning was prompted by results of two clinical trials linking DPP-4 inhibitors with heart failure. The label on Kazano was updated with the following warning:
“In the EXAMINE trial which enrolled patients with type 2 diabetes and recent acute coronary syndrome, 106 (3.9%) of patients treated with alogliptin and 89 (3.3%) of patients treated with placebo were hospitalized for congestive heart failure.”
Other FDA Safety Warnings for Kazano
- August 28, 2015 — The FDA is warning that Kazano may cause severe, disabling joint pain. The warning was issued after an FDA review of adverse events found 33 reports of joint pain associated with DPP-4 inhibitors since October 2006. Click here to read more.
- March 13, 2013 — Kazano has been named in a new Drug Safety Communication from the FDA in response to reports of a possible increased risk of pancreatitis and pancreatic cancer. Click here to read more.
What is Kazano?
Kazano (metformin and alogliptin) is a new oral medication for type-2 diabetes manufactured by Takeda Pharmaceuticals. When Kazano is used along with diet and exercise, it helps diabetics improve glycemic control after a meal.
Kazano contains a combination of two anti-diabetes drugs: metformin, which has been used to treat diabetes for decades, and alogliptin. Alogliptin is a new drug that was approved by the FDA in January 2013. It treats diabetes by preventing the enzyme dipeptidyl peptidase-4 (DPP-4) from destroying digestive hormones (called incretins). The result is higher levels of incretins, which stimulate the pancreas to produce more insulin, which lowers blood-sugar levels.
What is the problem with Kazano?
The alogliptin in Kazano belongs to a class of drugs called “incretin mimetics,” which all treat diabetes in essentially the same way. Unfortunately, because these drugs have only been on the market since 2006 (and Kazano is even newer), there is no information regarding long-term side effects. Although signals of pancreatitis were identified in clinical trials, complete risk information may not be fully understood for several more years.
According to the Prescribing Information for Kazano, it has already been associated with post-marketing reports of pancreatitis, which is a risk-factor for pancreatic cancer. There is also concerning evidence linking other incretin mimetic drugs to pancreatic cancer.
Study of Kazano and Pancreatic Cancer
In March 2013, the American Diabetes Association’s journal Diabetes published a study conducted by researchers who autopsied the pancreases of eight patients who were taking incretin mimetic drugs. The researchers wanted to see what effect incretin mimetic drugs have on the pancreas. Unfortunately, they found alarming evidence of pancreatitis (chronic inflammation) and pre-cancerous cellular changes.
They found that incretin mimetic drugs cause excessive growth of beta-cells in the pancreas — the pancreases of the incretin mimetic patients were 40% larger than normal and had 6-times more beta-cells. However, many of the cells were “eccentrically shaped,” and three patients had pre-cancerous adenomas. Adenomas are benign tumors that can become cancerous. According to the researchers:
“Since the standard of care of a pancreatic neuroendocrine tumor, because of the risk of conversion to malignancy, even if benign, is surgical resection [i.e. removal], patients exposed to incretin therapy would seem to be at increased risk of requiring pancreatic surgery.”
Patients who have surgery to remove pancreatic tissue due to an adenoma will likely require insulin injections for the rest of their life. Furthermore, there is a higher chance that the patient will develop life-threatening pancreatic cancer.
Kazano Class Action Lawsuit
Our attorneys are not filing a Kazano class action. Instead, we are filing individual lawsuits and only accepting cases involving severe side effect like pancreatic cancer. Over 750 individual lawsuits involving side effects of incretin mimetic diabetes drugs have been centralized into one federal court in California, Multi-District Litigation (MDL No. 2452).
Do I have a Kazano Lawsuit?
The Schmidt Firm, PLLC is currently accepting Kazano induced injury cases in all 50 states. If you or somebody you know was injured by pancreatic cancer after taking Kazano, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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