Both of the active ingredients in Oseni can cause or exacerbate heart failure, according to the FDA. The label was updated with new warnings after a study found that 3.9% of patients with pre-existing heart problems were hospitalized with heart failure.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Oseni 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.
What is the problem?
Oseni is a type-2 diabetes medication made by Takeda Pharmaceuticals that combines alogliptin and pioglitazone. These drugs work in different ways to control blood-sugar, and they are both associated with heart failure.
Oseni Label Has “Black Box” Warning for Heart Failure
Oseni has a “Black Box” warning label about the risk of heart failure, which is the strongest warning the FDA can require on a medication. The ingredient pioglitazone can cause or worsen heart failure, according to the Prescribing Information (PDF):
“Oseni can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough.”
FDA Issues Warning for Oseni and Heart Failure
The FDA has been investigating the risk of heart failure from alogliptin since February 2014. In April 2016, the agency issued a Safety Communication to warn that it may increase the risk of heart failure, especially in people who have pre-existing heart disease or kidney problems.
The warnings were issued after the FDA evaluated data from the EXAMINE clinical trial involving 5,380 adults with diabetes and a recent history of heart problems (heart attack or hospitalization for severe chest pain). The patients were tracked for 1.5 years on average, and up to 3.4 years. Researchers linked alogliptin with an increased risk of heart failure and updated the label on Oseni to warn:
“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.”
Warning Signs & Symptoms of Heart Failure
The FDA recommends that patients on Oseni should seek emergency medical attention if they develop symptoms of heart failure, such as:
- Rapid weight-gain due to fluid retention
- Swelling in the ankles, feet, legs, or stomach
- Shortness of breath during normal activities
- Breathing problems, especially when lying down
- Weakness, fatigue, or tiredness
What is Congestive Heart Failure?
Heart failure means that the heart is not working as well as it should, either because it is not pumping enough blood into the body (systolic) or because it is not filling with blood (diastolic). The term “congestive” refers to fluid buildup around the heart, lungs, and the rest of the body. As heart failure progresses, the kidneys do not remove enough fluid and salt in urine. This causes swelling (edema) and makes it harder for the heart to do its job.
Type-2 Diabetes and Heart Failure
Having diabetes is a major risk-factor for heart failure, and the risk-benefit profile of any medications linked to cardiovascular problems must be carefully considered with a healthcare professional. About 68% of people with diabetes die from heart disease or a stroke and they are at least twice as likely to develop heart problems.
Do I have an Oseni Lawsuit?
The Schmidt Firm, PLLC is currently accepting Oseni 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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