A recent study has found that 3.9% of patients on the diabetes drug Kazano were hospitalized with heart failure. The FDA has updated the label to include this risk information.
Need a Texas Kazano Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with heart failure or cancer, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
What is Kazano?
Kazano is a medication that treats type-2 diabetes with a combination of alogliptin and metformin. The alogliptin belongs to a class of drugs known as DPP-4 inhibitors and it helps control blood-sugar levels by increasing insulin.
Kazano and Heart Failure
April 4, 2016 — The FDA has issued a Safety Communication to warn that Kazano may increase the risk of heart failure, particularly in patients with kidney disease or pre-existing heart problems.
Studies Linking Kazano and Heart Failure
Kazano and other DPP-4 inhibitors were associated with heart failure in two large clinical trials:
- EXAMINE: Clinical trial involving 5,380 patients with type-2 diabetes and pre-existing heart disease. Patients were followed for 1.5 years on average. More patients on alogliptin (106 patients; 3.9%) were hospitalized with heart failure than patents on a placebo (89 patients; 3.3%).
- SAVOR-TIMI: Saxagliptin associated with a 27% increased risk of heart failure. Conclusions were based on data from 16,500 patients on saxagliptin or a placebo. After two years, 3.5% of patients on saxagliptin were hospitalized with heart failure vs. 2.8% of patients on a placebo.
Diabetes and Heart Failure
Studies linking diabetes medications and heart problems are concerning because people with type-2 diabetes are up to 4X more likely to develop heart disease or a stroke. About 68% of diabetics over 65 years old die from some form of heart disease, according to the American Heart Association.
The Prescribing Information (PDF) for Kazano includes a “Black Box” warning about lactic acidosis, a side effect of metformin that is more likely to occur in patients with congestive heart failure. The label also warns that alogliptin may increase the risk of heart failure:
“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.”
What is Heart Failure?
Heart failure occurs when the heart is not pumping enough blood into the body. It is not the same as a heart attack and it does not mean the heart has stopped working. However, it is very serious and can become life-threatening.
The term “congestive” heart failure (CHF) refers to the buildup of fluid in the body (edema) and in the lungs. Symptoms may include:
- Shortness of breath during daily activities or when lying down
- Lack of appetite
- General tiredness or weakness
- Swelling of the legs, feet, ankles, or abdomen
- Rapid or irregular heartbeat
- Rapid weight-gain due to fluid build up
Need a Kazano Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Kazano lawyers for a free lawsuit review.