The diabetes drug Nesina has been linked to an increased risk of heart failure. The FDA updated the label after a study found that 3.9% of patients on Nesina were hospitalized with congestive heart failure.
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Nesina and Heart Failure
Nesina (alogliptin) is a type-2 diabetes drug made by Takeda Pharmaceuticals. In April 2016, the FDA issued a Safety Communication to warn that it may increase the risk of heart failure, especially in patients with pre-existing heart problems or kidney disease.
The warnings came after the FDA reviewed two large clinical trials involving saxagliptin and alogliptin. These drugs are part of the class of dipeptidyl peptidase-4 (DPP-4) inhibitors, which help lower blood-sugar levels by increasing insulin levels.
Study Links Nesina and Heart Failure
The EXAMINE clinical trial included 5,380 patients on alogliptin and found that 3.9% (109 patients) were hospitalized with heart failure vs. 3.3% (89 patients) on a placebo. The difference was not statistically significant, but the study was not designed to investigate the risk of heart failure.
The SAVOR clinical trial involved nearly 16,500 patients on saxagliptin or a placebo and found a 27% increased rate of hospitalization for heart failure (3.5% vs. 2.8% on a placebo). The study also found a possible increase in the risk of all-cause mortality.
Nesina Heart Failure Warning Label
The FDA determined that the potential heart risks of Nesina were not serious enough to justify a recall or restrictions, but they did recommend stronger warnings. The Prescribing Information (PDF) has been updated with the following warning:
“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 occurs when the heart is unable to pump enough blood into the body. Patients on Nesina should seek emergency medical attention if they develop signs and symptoms of heart failure, such as:
- 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
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