LAWSUITS & SETTLEMENTS
What JANUVIA Is Used For?
Januvia is an oral medication prescribed to treat type 2 diabetes. It was approved by the FDA in 2006 and is sold by U.S.-based pharmaceutical company Merck.
In 2017, Januvia was the top-selling non-insulin diabetes medication in the world, with over $3.9 billion in sales.
The formulation for Januvia (sitagliptin) is also sold as a combination drug along with Metformin under the name Janumet, bringing total sales to over $6.1 billion per year.
Januvia and Janumet are among the DPP-4 class of incretin drugs, which also includes Onglyza and Tradjenta. The hormone GLP-1 normally promotes insulin production after meals to lower blood sugar, but this is inactivated by the enzyme DPP-4. By suppressing DPP-4, these incretin drugs help regulate glucose levels in the blood.
Unfortunately, studies have shown that manipulation of these hormones may have serious side effects, such as pancreatitis and a higher risk of cancer.
HOW JANUVIA WORKS?
Januvia is known as a dipeptidyl peptidase-4 (DPP-4) inhibitor which is an approved treatment in conjunction with proper diet and exercise for those diagnosed with Type-2 diabetes. The drug was first introduced to the market by Merck in October of 2006 and shortly thereafter was linked to pancreatic disease such as cancer.
Januvia (sitagliptin) is a prescription oral diabetes drug developed by Merck & Company to control the body’s blood sugar levels. The drug is effective because it regulates insulin levels in the body after eating. The medication has been approved to treat Type II diabetes and is not effective for Type I diabetes. The FDA approved the medication in October 2006 to be used alone or concomitantly with other diabetic drugs.
SYMPTOMS & SIDE EFFECTS OF JANUVIA
Pancreatic cancer is a dangerous disease that starts in the cells of the pancreatic lining. From there, it can spread quickly, often without detection until it is too late.
According to the National Cancer Institute, an estimated 53,670 people will be diagnosed with pancreatic cancer this year, and 43,090 will die. This makes it the third most deadly form of cancer, behind only lung and colon/rectal cancer.
- Weight loss
- Itchy skin
- Pale or gray colored stools
- Darkened urine
- Jaundice in skin or eyes
- Persistent loss of appetite
- Back pain
- Abdominal pain
- Nausea or vomiting
- Swelling of the liver or gallbladder (lump in abdomen)
- Blood clots.
If you have experienced persistence of any of these symptoms, it is important to talk with your doctor immediately. This is especially true if you are a diabetic or are taking an incretin drug like Januvia.
Latest JANUVIA News & Recalls
The protein DPP-4 is an important part of the digestive and metabolic process. What’s more, it may also be essential in stopping the development of certain cancers and tumors. Studies have shown that blocking this enzyme can lead to a spreading of cancer cells.
Incretin drugs like Januvia not only inhibit DPP-4, but have also been shown to increase risks for pancreatitis. This condition, which leads to inflammation of the lining of the pancreas, is considered a major risk factor for pancreatic cancer.
In 2009, the FDA first warned that a higher-than-normal number of patients taking Januvia reported suffering pancreatitis.
Researchers then identified a link to pancreatic cancer in 2011, when a UCLA study found patients taking Januvia had almost 3 times the risk of the disease. The FDA warned of pre-cancerous findings in incretin drug patients in 2013, and said it would order further testing.
Despite additional warnings of Januvia and pancreatic cancer by the American Medical Association and the American Diabetes Association, the FDA concluded in 2013 there wasn’t enough evidence to warn patients of pancreatic cancer.
2017 Januvia Pancreatic Cancer Study
After years of inaction by the FDA, a new study emerged in October 2017 that showed patients taking incretin drugs like Januvia had significantly higher risks for pancreatic cancer than those taking other drugs.
From 2008 to 2013, European researchers in Belgium, France and Italy gathered data on nearly 560,000 type 2 diabetes patients taking either an incretin drug like Januvia or a different type of non-insulin drug called a NIAD.
From this, they were able to measure the difference in pancreatic cancer diagnoses based on what type of medication patients took.
The results showed patients taking incretins had 3.35 times as much risk for pancreatic cancer as those taking NIADs during the first three months. As the time of use increased, the risk fell, but was still around double the rate of pancreatic cancer as with NIAD drugs.
Researchers concluded that recent use of incretin drugs like Januvia was linked to a higher risk of pancreatic cancer. They advised more studies be performed to determine the long-term danger of cancer from these drugs.
Lawsuits & Settlements
In an Oct. 16 motion, Michael London, of New York-based Douglas & London, who is co-lead plaintiffs’ counsel in the multidistrict litigation in New Jersey, asked the court to set up a qualified settlement fund of a “confidential settlement amount” to resolve his inventory of cases.
The defendants, Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals Inc., “have entered into confidential master settlement agreements to resolve the actions, disputes and claims of certain claimants represented by D&L relating to diabetic ketoacidosis, acute kidney injury and amputation injuries and losses allegedly suffered by those claimants in connection with Invokana/Invokamet.”
Although the FDA has not warned of these pancreatic cancer risks or issued a Januvia recall, courts have ruled that patients and family members affected have the right to seek compensation for their loss.
So far, nearly 1,000 plaintiffs have filed incretin drug or Januvia lawsuits after being diagnosed with pancreatic cancer. However, these cases are still awaiting trial and no settlement amounts have been released.
The Januvia lawsuits began in August 2013 when the Judicial Panel on Multidistrict Litigation created a central federal court to handle the growing number of cases filed by victims around the country.
This came to be known as MDL -2452, IN RE: Incretin-Based Therapies Products Liability Litigation, under the supervision of U.S. District Judge Anthony J. Battaglia in the Southern District of California.
In November 2015, the majority of these cases were dismissed after manufacturers claimed they had complied with FDA requirements in disclosing all risks. However, an appeals court ruled in December 2017 that the cases would be reinstated and will proceed to trial.
2018 MDL Lawsuit
According to the latest information from the Judicial Panel on Multidistrict Litigation, there are now 936 cases pending in the Januvia and incretin MDL lawsuit in 2018, and that number is expected to grow.
While this special MDL court functions somewhat like a Januvia Class Action Lawsuit, it has advantages for plaintiffs in that cases are filed separately and those injured have more control over their case and decisions on settlement amounts.
Based on the significant damages suffered by those dealing with pancreatic cancer or who have lost a family member, lawyers expect the verdicts or settlement amounts of these lawsuits will be substantial.
Lawyers are still accepting cases on behalf of those patients diagnosed with pancreatic cancer after taking Januvia or another incretin drug, as well as families of those who have passed away. To speak directly with a lawyer at no cost, contact Healthcare Advocacy Group today.