Januvia and Byetta, along with Janumet and Victoza, are the diabetes drugs at the center of 945 lawsuits. The cases had originally been dismissed, but a federal appeals court overturned that decision in December of 2017, and remanded the cases back to U.S. District Judge Anthony Battaglia in the Southern District of California. He has ordered that the first bellwether cases must be selected by December 14, 2018, which means the courts could be hearing those cases by 2020.
The first lawsuits against the manufacturers of these drugs were filed in 2013, and the first safety alerts were issued in 2007. For the victims and their families, these lawsuits have been a very long time coming.
What are Januvia and Byetta?
Januvia, Janumet, Byetta and Victoza are “incretin mimetics.” They are designed to mimic incretin hormones – the types of hormones that stimulate the secretion of insulin after you eat, and your body digests the food. The goal is to help people with Type 2 diabetes regulate their blood sugar.
The problem is that incretin therapies is that they increase your risk of developing very serious health conditions and complications, including pancreatic cancer. Some of the other conditions and diseases Byetta and Januvia have been linked to include:
- Acute pancreatitis
- Hemorrhagic pancreatitis
- Necrotizing pancreatitis
- Issues with the kidneys
- Gallbladder disease
- Thyroid cancer
The lawsuits moving forward now are concerned with the link to pancreatitis and pancreatic cancer, only.
The research on the risks has been clear
In 2011, the journal Gastroenterology said that patients who use incretin therapies are at an increased risk of developing pancreatic cancer, and that they are six times more likely to develop pancreatitis.
In 2013, the Food & Drug Administration (FDA) issued a safety communication regarding the use of incretin mimetics, like Januvia and Byetta, and an increased risk of pancreatitis and pancreatic cancer, based on the conclusion of study published in JAMA Internal Medicine. That same year, the journal Diabetes published a study that found incretin therapies caused considerable inflammation of the pancreas (pancreatitis), and that patients who used these types of drugs were at an increased risk of developing pancreatitis and pancreatic cancer.
The latest study published in Diabetes Care looked at 33,292 people treated with incretin drugs (and more than half a million patients treated with different types of medications), and found that the risk of developing pancreatic cancer doubled in patients taking incretin therapies: “The recent prescription of incretin therapy is associated with an increased risk of pancreatic cancer. The reason for such an increase is likely the consequence of an occult pancreatic cancer that provokes or aggravates diabetes. Studies are warranted for assessing the risk of pancreatic cancer associated with long-term use of incretin drugs.”
What you should know about pancreatitis and pancreatic cancer
Pancreatic cancer is an extremely aggressive disease: it spreads rapidly, and many people do not develop symptoms until the disease is in its later stages. Though it is a less common type of cancer, accounting for about 3% of all cancer diagnoses in the country each year, it is one of the most deadly forms there is. The American Cancer Society estimates that “The 5-year survival rate for people with stage IA pancreatic cancer is about 14%. For stage IB cancer, the 5-year survival rate is about 12%…. Stage IV pancreatic cancer has a 5-year survival rate of about 1%.”
Pancreatitis is another serious condition; there are treatments available, but there is no cure. People with pancreatitis are more likely to develop pancreatic cancer. They are also at risk of complications including kidney failure, malnutrition, respiratory problems, infections, and pseudocysts, per the Mayo Clinic.
Why were the original lawsuits dismissed?
The original lawsuits claimed that the FDA should have warned patients of the potential risks of developing pancreatitis and pancreatic cancer if they were taking drugs like Januvia or Byetta. Judge Battaglia, however, said that the FDA had not had conclusive evidence of that at the time, and therefore the “failure to warn” claims were dismissed. After all, if the manufacturers lied or misrepresented the dangers of their drugs to the FDA, then FDA would not have been within their rights to mandate a change to the label for those risks.
The appellate court, however, disagreed; they believe that the charges were dismissed too quickly to accurately ascertain what information was or was not supplied to the FDA by the manufacturers. For this latest round, new information and discovery will be submitted to the court to support the theory that the manufacturers failed in their duty to warn of the dangers of the medications.