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Nesina Heart Failure

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Concerns about a possible link between Nesina and heart failure arose in April 2015, after a U.S. Food & Drug Administration (FDA) panel recommended new label warnings for the Type 2 diabetes drug.

Nesina Legal Review

Bernstein Liebhard LLP is investigating legal claims involving Nesina and heart failure. If you would like to learn more about filing a Nesina lawsuit, please call (888) 994-5118 to speak with a member of our legal team today.

FDA Panel Recommends Nesina Heart Failure Warning

Nesina (alogliptin) is an incretin mimetic sold by Takeda Pharmaceuticals for the treatment of people with Type 2 diabetes. In April 2015, the FDA’s Endocrinology and Metabolic Drugs Advisory Committee (EMDAC) voted 13-3 to recommend that a new heart failure warning be included on the drug’s label. The Panel’s recommendation was based on a review of the EXAMINE trial, which found an increase in the rate of hospitalization for heart failure in patients who were taking Nesina.

The EXAMINE study analyzed data from 5,400 patients with Type 2 diabetes who also had an established history of cardiovascular disease, all of whom were treated with either Nesina or a placebo. During the 18-month study, 106 patients assigned alogliptin experienced at least one hospitalization for heart failure vs. 89 patients assigned placebo.

As of March 2016, the FDA had not acted on the advisory panel’s recommendation. While the agency is not required to abide by the advice of its panels, it usually does so.

What is Heart Failure?

About 5.7 million people in the United States have heart failure. The condition occurs when the heart is unable to pump enough blood to meet the body’s needs. Most cases of heart failure affect both sides of the heart. But if only the right side is impacted, the heart won’t be able to pump enough blood to the lungs to pick up oxygen. If the left side is affected, the heart can’t pump enough oxygen-rich blood to the rest of the body.

Heart failure can result from any disease that damages the heart, such as coronary heart disease (CHD), high blood pressure, and diabetes.

Signs and symptom of heart failure include:

• Shortness of breath or trouble breathing
• Fatigue (tiredness)
• Swelling in the ankles, feet, legs, abdomen, and veins in the neck
• Pulmonary edema (fluid in the lungs)
• Pleural effusion (fluid around the lungs)
• Coughing that gets worse at night

Filing a Nesina Lawsuit Can Help

If you or loved one were hospitalized for heart failure while taking Nesina, the attorneys at Bernstein Liebhard LLP are ready to help. To arrange for your free legal review, please call (888) 994-5118