Oseni combines two diabetes medications, both of which may cause or worsen heart failure. In one clinical trial, 3.9% of patients with diabetes and heart problems were hospitalized with congestive heart failure.
Need a Texas Oseni 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, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
What is the problem?
Oseni “Black Box” Warning for Heart Failure
The Prescribing Information (PDF) has a “Black Box” warning that Oseni can cause or exacerbate heart failure. Pioglitazone can cause the body to keep extra fluid, which can lead to swelling (edema) and weight-gain. Extra body fluid can worsen some heart problems or cause heart failure.
FDA Heart Failure Warnings for Oseni
In February 2014, the FDA began investigating the risk of heart failure from alogliptin, another ingredient in Oseni. In April 2016, the agency concluded that it may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.
The FDA evaluated the EXAMINE clinical trial, which tracked 5,380 patients for an average of 1.5 years. All of the patients had type-2 diabetes, pre-existing cardiovascular disease, and a recent heart attack or severe chest pain that required hospitalization. After alogliptin was linked to higher rates of heart failure, the label on Oseni was updated with the following warning:
“In the EXAMINE trial which enrolled patients with type-2 diabetes and recent acute coronary syndrome, 106 (3.9%) of patients treated with alogliptin and 89 (3.3%) of patients treated with placebo were hospitalized for congestive heart failure.”
Recommendation for Patients
According to the FDA, patients on Oseni should call their doctor right away if they develop signs and symptoms of heart failure, such as:
- Swelling or fluid retention, especially in the ankles, feet, legs, or stomach
- Unusual shortness of breath during daily activities
- Trouble breathing, especially when lying down
- Unusually fast weight-gain (may be due to fluid)
- Weakness, fatigue, or tiredness
What is Heart Failure?
Congestive heart failure is a chronic condition in which the heart does not work as well as it should. It occurs when the heart cannot adequately pump blood (systolic) or fill with blood (diastolic). As heart failure worsens, the kidneys stop removing excess fluids and salts from the body in urine. This causes fluid to accumulate around the heart and lungs, which makes it harder for the heart to pump blood.
Diabetes and Heart Failure
Diabetes is one of the most common causes of heart failure. In fact, about 68% of people with diabetes die from heart disease or a stroke. The risks and benefits of any diabetes drugs that further increase the chance of heart problems must be carefully considered.
Need an Oseni Lawyer in Texas?
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