Update: FDA Warning on Rhabdomyolysis Risk with Kazano
December 1, 2017 – The U.S. Food & Drug Administration has recently obtained data indicating that Kazano and other DPP-4 inhibitors may increase the risk for rhabdomyolysis, a severe muscular disease characterized by the breakdown of skeletal muscle. If after further evaluation the agency determines that these medicines are indeed associated with the risk, it may take a variety of actions, including requiring changes to the labeling of the drugs, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.
What is Kazano?
Kazano is a combination alogliptin and metformin, diabetes medications that help control blood sugar levels. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines, while alogliptin works by regulating levels of insulin the body produces after eating. Kazano is made by Takeda Pharmaceuticals, and was approved by the U.S. Food & Drug Administration (FDA) in January 2013.
Incretin Mimetics and Pancreatic Cancer
A study published in the March 22, 2013 online edition of Diabetes looked at the effect of incretin mimetic diabetes drugs on the pancreas. The researchers autopsied the pancreases of 8 incretin mimetic users, and found evidence of pancreatitis (chronic inflammation) and pre-cancerous cellular changes.
They further determined that the drugs caused excessive growth of beta cells in the pancreas – the pancreases of patients treated with incretin mimetics were 40% larger than normal and had 6x more beta cells. Additionally, many of the cells were ‘eccentrically shaped,’ and 3 patients had pre-cancerous adenomas (benign tumors that have the potential to become cancerous).
Patients who have surgery to remove pancreatic tissue due to an adenoma will likely require insulin injections for the rest of their lives. Furthermore, there is an increased risk that the patient will go on to develop pancreatic cancer.
Pancreatic Cancer Symptoms
- Yellow skin and eyes (jaundice)
- Darkening of the urine
- Clay-colored stool
- Pain in upper abdomen or upper back
- Swelling of the arms or back
- Burning feeling in stomach / bloating
- Loss of appetite
- Unexplained weight loss
DPP-4 Inhibitors Linked to Severe Skin Disorder
Diabetes medications from the DPP-4 inhibitor class have been known to cause a rare skin disease known as bullous pemphigoid (BP). The condition causes symptoms of blistering on the arms, legs, abdomen, and mucous membranes. Hives and itching are also common signs of the condition. In October 2016, FDA asked DPP-4 manufacturers to include a pemphigoid warning to their medication’s labeling. All manufacturers complied by January 2017, according to the FDA.
Kazano Side Effects
- Acute pancreatitis (pancreas inflammation)
- Pancreatic cancer
- Thyroid cancer
- Heart failure
- Lactic acidosis
- Impaired liver function
- Kidney problems
Has the Drug Been Recalled?
Despite growing evidence linking Kazano to pancreatic cancer and other serious side effects, no recall has been issued for the drug and it continues to be prescribed to diabetes patients around the country. However, in the absence of a Kazano recall, former users who were diagnosed with pancreatic cancer may be able to file a product liability claim against the manufacturer.
Do I Have a Kazano Class Action Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Kazano lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by the side effects of Kazano, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.