The FDA is warning about heart failure risks from the diabetes drug Kazano after a study in patients with pre-existing heart disease found that 3.9% were hospitalized with 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 has been diagnosed with heart failure or pancreatic cancer, 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 toll free 24 hours a day at (866) 920-0753.
What is Kazano?
Kazano is a diabetes drug that combines alogliptin and metformin. These medications work in different ways to control blood-sugar levels. Alogliptin is a member of the DPP-4 inhibitor class of drugs and it works by increasing insulin levels.
FDA Warning for Kazano Heart Failure Risk
In April 2016, the FDA issued a Safety Communicationabout the risk of heart failure from all DPP-4 inhibitors, including Kazano. The agency warned that the drugs may increase the risk of heart failure, especially in people who already have problems with their heart or kidneys.
What Studies Link Kazano and Heart Failure?
The FDA warning was prompted by concerning data from two large clinical trials — one involving alogliptin and the other involving saxagliptin (Ongylza), another DPP-4 inhibitor. These studies include:
- EXAMINE: Study involving nearly 5,500 diabetic adults with pre-existing coronary heart disease. Patients were followed for an average of 1.5 years. Researchers found that 109 patients (3.9%) were hospitalized with heart failure, vs. 89 patients (3.3%) on a placebo.
- SAVOR-TIMI: Study involving 16,500 patients linked saxagliptin with a 27% increased risk of hospitalization for heart failure (3.5% vs. 2.8% of patients on a placebo).
Diabetes and Heart Failure
The American Heart Association warns that heart disease kills 68% of people with diabetes over the age of 65. Furthermore, people with diabetes are two- to four-times more likely to have heart disease or a stroke. Any medications that further increase these risks are concerning.
Kazano Label Updated With Heart Failure Warnings
The Prescribing Information (PDF) on Kazano has a “Black Box” warning about lactic acidosis, which is a side effect of metformin that is more likely to occur in patients with heart failure. The label also warns that alogliptin may increase the risk:
“Consider the risks and benefits of KAZANO prior to initiating treatment in patients at risk for heart failure, such as those with a prior history of heart failure and a history of renal impairment, and observe these patients for signs and symptoms of heart failure during therapy. Patients should be advised of the characteristic symptoms of heart failure and should be instructed to immediately report such symptoms. If heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of KAZANO.”
Warning Signs & Symptoms of Heart Failure
Heart failure is when the heart is not providing the body with enough blood. “Congestive” heart failure (CHF) occurs along with edema, which is when fluid builds up in the longs and body. According to the FDA, Kazano patients should be aware of the warning signs of heart failure and seek emergency medical attention. These symptoms include:
- Unusual shortness of breath during daily activities
- Trouble breathing when lying down
- Tiredness, weakness, or fatigue
- Weight gain with swelling in the ankles, feet, legs, or stomach
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 has been diagnosed with heart failure or pancreatic cancer, 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 toll free 24 hours a day at (866) 920-0753.
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