Update: FDA Adds Heart Failure Warning to Oseni Labels
April 5, 2016 – The U.S. Food & Drug Administration (FDA) announced today that it was adding a new warning to the labels of diabetes drugs containing saxagliptin and alogliptin. FDA said the medications “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.” The announcement comes 2 years after an FDA panel recommended that the drugs’ labels should be updated but did not recommend any other harsher measures.
What is Oseni?
Oseni combines the prescription medications alogliptin and pioglitazone to treat type 2 diabetes (formerly known as adult-onset or noninsulin-dependent diabetes). The drug works by helping stimulate the release of more insulin after a meal to control blood sugar. Oseni belongs to a class of diabetes drugs known as incretin mimetics, and was approved by the FDA on January 25, 2013.
Oseni Pancreatic Cancer Study
In March 2013, a study published in the journal Diabetes looked at the risk of pancreatitis and pancreatic cancer associated with incretin mimetic diabetes drugs like Oseni. The researchers performed autopsies on pancreases from incretin mimetic users, and found evidence of pancreatitis and pre-cancerous cells — 2 major risk factors for pancreatic cancer.
The researchers further determined that patients who were treated with incretin mimetics had pancreases that were 40% larger than normal and contained “eccentric” cell growth. At least 3 pancreases had adenomas — benign, pre-cancerous glandular tissue growths that have the potential to become malignant. There was no evidence of this in pancreases from patients who did not use incretin mimetics.
Pancreatic Cancer Symptoms
- Back pain
- Gastrointestinal distress
- Loss of appetite
- Dark urine
- Weight loss
- Yellow skin and eyes (jaundice)
While pancreatic cancer survival rates have been steadily improving over the years, the disease is still considered largely incurable. According to the American Cancer Society, for all stages of pancreatic cancer combined, the one-year survival rate is about 20%, and the five-year rate is 6%.
Oseni Side Effects
- Pancreatic cancer
- Thyroid cancer
- Acute pancreatitis
- Hemorrhagic pancreatitis
- Necrotizing pancreatitis
DPP-4 Inhibitors and Bullous Pemphigoid
In October 2016, the FDA asked manufacturers of DPP-4 inhibitor diabetes drugs to add a label change to their products regarding an increased risk of bullous pemphigoid (BP), a rare skin disorder that causes symptoms of blistering on the arms, legs, abdomen, and mucous membranes. All patients who developed the disease had severe outcomes, including one person who died from complications. As a result of these problems, FDA required a class-wide label change to reflect the risk of bullous pemphigoid with DPP-4 inhibitors.
Do I Have an Oseni Class Action Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Oseni lawsuits. We are handling individual litigation nationwide and currently accepting new pancreatic cancer and heart failure cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by Oseni side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.