The U.S. Food and Drug Administration (FDA) is warning that incretin mimetic diabetes drugs like Oseni may increase the risk of pancreatic cancer, heart failure, rhabdomyolysis, and other serious side effects.
Free Confidential Lawsuit Evaluation: If you or a loved one got pancreatic cancer after taking Oseni, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: FDA Evaluating Risk of Rhabdomyolysis with Oseni
December 1, 2017 - Diabetes patients who took DPP-4 inhibitors like Oseni have been diagnosed with rhabdomyolysis, a severe muscle-wasting condition, according to the FDA Adverse Event Reporting System (FAERS) [1]. FDA is evlaluating whether regulatory action needs to be taken on the class of drugs, and will inform the public as more information becomes available.
Overview
Manufactured by Takeda Pharmaceuticals, Oseni was approved by the FDA on January 25, 2013 as a treatment for type 2 diabetes mellitus. The drug increases the body’s sensitivity to insulin while simultaneously inhibiting the production of sugar by the liver. This prevents the accumulation of sugar in the bloodstream and reduces the symptoms of resulting complications.
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Oseni Side Effects
Despite demonstrating considerable effectiveness as a diabetes medication, Oseni belongs to a class of drugs which have recently been linked to the following serious side effects:
- Pancreatic cancer
- Thyroid cancer
- Heart failure
- Rhabdomyolysis
- Pancreatitis
- Acute pancreatitis
- Hemorrhagic pancreatitis
- Necrotizing pancreatitis
- Death
Other, less severe Oseni side effects may include:
- Shortness of breath
- Swelling
- Rapid weight gain
- Chest pain
- Ill feeling
- Nausea
- Stomach pain
- Fever
- Dark urine
Click here to learn more about Oseni side effects from Drugs.com [2]
FDA Investigates Oseni Cancer Link
In March 2013, the FDA announced that it was investigating the potential association between incretin mimetics like Oseni and cancer of the pancreas and thyroid. The administration made the decision to investigate the drugs after research was presented which found patients who were treated with incretin mimetics faced an increased risk of developing cancer. The administration requested additional data from the researchers on the methods used to reach their findings, as well as for tissue samples so the agency may investigate the potential link between the drugs and cancer.
Concerns about thyroid cancer from incretin mimetics first emerged after animal studies identified a link between Victoza (another incretin mimetic in the same class as Oseni) and thyroid cancer. A black box warning about the risk of thyroid cancer was placed on Victoza labels, and many have expressed concerns that the same warning should be placed on Oseni and other incretin mimetic labels.
Related Article: Oseni Class Action Lawsuit
FDA Warns DPP-4 Inhibitors Can Cause Severe Joint Pain
The FDA said it had identified 33 cases of severe joint pain in patients treated with DPP-4 inhibitor diabetes medications, according to a Drug Safety Communication issued August 28 [3]. The agency added a new Warning and Precaution about this risk to the labels of all medicines in this class.
Study Highlights Risks of Combining Oseni with Other Diabetes Drugs
June 23, 2016 - A new study published in the British Medical Journal (BMJ) [4] has found that combining DPP-4 inhibitors like Oseni with “sulphonylureas” may increase the risk of hypoglycemia (low blood sugar), a potentially life-threatening condition.
Oseni May Increase Heart Failure Risk, FDA Warns
April 5, 2016 - An FDA safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. As a result of the problems, the agency is requiring new warnings [5] to the drug labels regarding this safety issue.
Studies Link DPP-4 Inhibitors to Bullous Pemphigoid
A study published in Dermatology [6] in 2016 looked at 3 cases of DPP-4 inhibitor use associated with bullous pemphigoid (BP), a rare skin disorder that causes skin rashes and blistering on the legs, arms and abdomen. All 3 patients showed a clear temporal relationship between DPP-4 inhibitor therapy and onset of the condition. One case was due to Tradjenta use, while the other 2 cases were linked to a combination of Galvus / vildagliptin-metformin.
Oseni Pancreatitis Update 6/12/13: An article published this week in the British Medical Journal (BMJ) [7] has called into question why the risk of pancreatitis posed by incretin mimetic diabetes drugs has been underplayed in the media. A number of recent studies have found that users of these medications are twice as likely to be hospitalized for acute pancreatitis compared to individuals who take other types of diabetes drugs.
Do I Have an Oseni 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 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.
