The FDA is investigating evidence linking the diabetes drug Oseni (alogliptin + pioglitazone) with pancreatitis, pancreatic cancer, heart failure, rhabdomyolysis, and more.
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 was diagnosed with pancreatic cancer or 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 us toll-free 24 hours a day at (866) 920-0753.
FDA Evaluating Rhabdomyolysis Risk
The FDA is evaluating a potential signals of a serious risk and new safety information linking DPP4 diabetes drugs and rhabdomyolysis. This potentially life-threatening kidney side effect was identified by the FDA Adverse Event Reporting System (FAERS) between April and June 2017.
What is Oseni?
In January 2013, the FDA approved Oseni, an oral medication for treating type-2 diabetes that is manufactured by Takeda Pharmaceuticals. Oseni combines two drugs:
- Alogliptin (Nesina): This drug treats diabetes by inhibiting dipeptidyl peptidase-4 (DPP-4), which increases levels of metabolic hormones called incretins that lower blood-sugar levels.
- Pioglitazone (Actos): This is a type of drug called a thiazolidinedione (TZD). Unfortunately, Takeda is facing more than 3,000 lawsuits from people who used pioglitazone and developed bladder cancer or congestive heart failure.
What is the problem?
Oseni has been linked to many severe, life-threatening side effects, including bladder cancer, pancreatic cancer, congestive heart failure, pancreatitis, and more. Because it is a new drug that has only been on the market since 2013, it could be many years until researchers fully understand long-term risks like cancer. However, there is already concerning evidence linking Oseni to cancers and serious heart problems.
FDA Safety Warnings for Oseni
- April 2016 — The FDA is warning that Oseni may increase the risk of heart failure, especially for patients who already have heart disease or kidney problems. Click here to read more.
- August 2015 — The FDA is warning that Oseni may cause severe, disabling joint pain. Click here to read more.
- March 2013 — The FDA is investigating evidence linking Oseni to higher rates of pancreatic cancer and pancreatitis. Click here to read more.
Oseni and Heart Failure
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 more patients on alogliptin were hospitalized with heart failure than patients on a placebo. The Prescribing Information (PDF) has the following “Black Box” warning about heart failure:
“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.”
The warnings were issued after the FDA reviewed data from the EXAMINE clinical trial. The study enrolled over 5,300 patients with type-2 diabetes and a recent history of heart attack or hospitalization for severe chest pain. After tracking the patients for an average of 1.5 years, researchers found that 106 (3.9%) of patients treated with alogliptin and 89 (3.3%) of patients treated with placebo were hospitalized for congestive heart failure. This information was added to the label
According to the FDA Safety Communication, patients taking Oseni should contact their health care professionals right away 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
Study of Oseni and Pancreatic Cancer
One of the most concerning studies of incretin mimetic drugs like Oseni and their link to pancreatitis and pancreatic cancer was published in March 2013 in Diabetes. Researchers performed autopsies on pancreases from patients who used an incretin mimetic and they found alarming evidence of pancreatitis and pre-cancerous cellular growths.
The researchers found that the patients’ pancreases were 40% larger than normal and contained “eccentric” cell growth. Three pancreases had adenomas, which are benign, pre-cancerous growths of glandular tissue that can become malignant. There was no evidence of pre-cancerous cells in pancreases from patients who did not take an incretin mimetic drug.
In conclusion, the researchers warned about the increased risk of pancreatic cancer and surgery:
“Since the standard of care of a pancreatic neuroendocrine tumor, because of the risk of conversion to malignancy, even if benign, is surgical resection [i.e. removal], patients exposed to incretin therapy would seem to be at increased risk of requiring pancreatic surgery.”
Oseni Class Action Lawsuit
The Schmidt Firm, PLLC is nationally recognized as a class action law firm, we are not filing an Oseni class action. Instead, we are filing individual lawsuits and only accepting cases involving severe side effects, such as pancreatic cancer and heart failure.
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 was injured by pancreatic cancer or 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 us toll-free 24 hours a day at (866) 920-0753.
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