The label on the diabetes drug Nesina has been updated to warn about a recent study in which 3.9% of patients were hospitalized with congestive heart failure.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Nesina induced injury cases in all 50 states. If you or somebody you know has been diagnosed with heart failure or 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.
Overview
Takeda Pharmaceuticals manufactures the type-2 diabetes drug Nesina (alogliptin). It belongs to the dipeptidyl peptidase-4 (DPP-4) inhibitor class of medications, which helps increase insulin levels and decrease blood-sugar.
FDA Issues Nesina Heart Failure Warning
In April 2016, the FDA published a Safety Communication about the risk of heart failure from Nesina, especially in patients with pre-existing heart disease or kidney problems. The agency issued the warning after two large clinical trials linked alogliptin and another DPP-4 inhibitor called saxagliptin with higher rates of hospitalization for heart failure.
Studies Linking Nesina and Heart Failure
- EXAMINE: Clinical trial enrolled 5,380 patients with type-2 diabetes and recent acute coronary syndrome. Patients were given alogliptin or a placebo. Researchers found that 106 patients (3.9%) were hospitalized with congestive heart failure vs. 89 patients (3.3%) on a placebo.
- SAVOR-TIMI: Clinical trial enrolled 16,500 patients on saxagliptin (Onglyza) or a placebo. Researchers found a 27% increased risk of heart failure — 3.5% of saxagliptin patients were hospitalized with heart failure vs. 2.8% on a placebo.
Diabetes and Heart Failure
People with diabetes are at least twice as likely to develop heart disease. At least 68% of people age 65 or older with diabetes die from some form of heart disease. This is why some experts are concerned about evidence linking diabetes medications with even higher rates of heart problems.
Nesina Label Updated With Heart Failure Warnings
The FDA has been investigating evidence linking DPP-4 inhibitors and heart failure for several years. After studies confirmed an increased risk, the agency updated the Prescribing Information (PDF) for Nesina with the following recommendation:
“Consider the risks and benefits of NESINA 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 NESINA.”
What is Heart Failure?
Heart failure is a medical condition in which the heart is not pumping enough blood into the body. It does not mean that the heart has stopped working. “Congestive” heart failure (CHF) occurs when fluid builds up in the body because the heart isn’t pumping properly. Symptoms may include:
- Unusual shortness of breath during daily activities
- Fatigue, tiring easily
- Breathing problems when lying down
- Weight gain with swelling in the ankles, feet, legs, or stomach
- Weakness
Do I have a Nesina Lawsuit?
The Schmidt Firm, PLLC is currently accepting Nesina induced injury cases in all 50 states. If you or somebody you know has been diagnosed with 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 toll free 24 hours a day at (866) 920-0753.
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