Oseni is a diabetes drug that is linked to severe side effects like pancreatitis, pancreatic cancer, rhabdomyolysis, and more.
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 injured by Oseni, you should contact our lawyers immediately. You may be entitled to compensation by filing an Oseni lawsuit in Texas.
Oseni Side Effects
- Bile duct disease
- Bullous pemphigoid
- Gallbladder disease
- Heart failure
- Joint pain
- Pancreatic cancer
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.
FDA Warnings for Oseni
The FDA has issued several warnings about side effects of Oseni:
- April 2016 — Safety Communication 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 28, 2015 — Safety Communication about the risk of severe, disabling joint pain from Oseni. Click here to read more.
- March 2013 — Safety Communication to announce that they are investigating a study published in March 2013 that suggests a potential risk of pancreatitis and pancreatic cancer from incretin mimetic drugs, including Oseni. Click here for more information.
What is Oseni?
Takeda Pharmaceuticals received approval for Oseni (alogliptin and pioglitazone) in January 2013. The alogliptin in Oseni is one of the newest drugs in a class of anti-diabetes medications called “incretin mimetics,” which are used to improve glycemic control (blood-sugar) levels in adults with type-2 diabetes.
Oseni combines the following medications:
- Alogliptin: Sold alone under the brand-name Nesina, alogliptin treats diabetes by inhibiting dipeptidyl peptidase-4 (DPP-4), which increases digestive hormones called incretins that regulate insulin and blood-sugar levels.
- Pioglitazone: Sold under the brand-name Actos, pioglitazone is a type of anti-diabetes drug called a thiazolidinedione (TZD). Unfortunately, clinical trials and post-marketing reports suggest that it increases a patient’s risk of bladder cancer and congestive heart failure.
What is the problem?
Oseni has only been sold in the United States since January 2013, but it has already been linked to severe side effects like pancreatitis, pancreatic cancer, bladder cancer, heart failure, and more. Unfortunately, the long-term risks of using Oseni are unknown.
Oseni and Heart Failure
The Prescribing Information (PDF) on Oseni has a “Black Box” warning that pioglitazone can cause or exacerbate heart failure. The FDA has also warned that alogliptin may cause heart failure, especially in patients with pre-existing heart disease or kidney problems.
According to the FDA, Oseni 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.
The label was updated after the FDA reviewed data from the EXAMINE clinical trial, which tracked over 5,300 adults with diabetes and a recent history of heart problems. The researchers concluded that patients on alogliptin were more likely to develop heart failure than patients on a placebo:
“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.”
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
Oseni and Pancreatic Cancer
The FDA began investigating the risk of pancreatic cancer from Oseni and other incretin mimetic drugs in March 2013. The FDA was concerend about a study published in the journal Diabetes. Resarchers autopsied pancreases that were taken from patients who used an incretin mimetic drug to treat diabetes.
Oseni increases hormones that cause the proliferation of beta-cells in the pancreas. Not surprisingly, the researchers found 6-times more beta-cells in the pancreases, which was why they were 40% more massive than normal. The problem was that many of the cells were “eccentrically shaped” and some were pre-cancerous.
Three out of eight pancreases had adenomas, which are benign pre-cancerous glandular tissue growths that can become malignant and cause deadly pancreatic cancer. The researchers warned:
“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 Lawyer
The Clark Firm, LLP is nationally recognized as a class action law firm in Texas. Our attorneys are filing individual lawsuits rather than an Oseni class action. We are currently accepting cases involving serious pancreatic side effects, such as pancreatic cancer.
Need an Oseni Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Oseni lawyers for a free lawsuit review.