If you have type 2 diabetes and you were given the drugs Januvia or Janumet, your life was put at risk. These drugs are now known to dramatically increase the risk of pancreatitis, or inflammation of the pancreas—a condition that can lead to pancreatic cancer. The FDA has received numerous reports of diabetes patients being hospitalized for pancreatitis or being diagnosed with cancer after using Januvia. Lawsuits now state that patients were not given proper warning, and that doctors were not notified of the risk. People with diabetes were endangered by the very drugs that were supposed to help them.

At John Foy & Associates, we’re taking a stand against this sort of reckless behavior from the pharmaceutical industry. We are investigating possible lawsuits against Merck, the manufacturer of Januvia and Janumet. We would like to speak to you if you or a loved one have taken either of these drugs and suffered from adverse effects such as pancreatic cancer, pancreatitis, thyroid cancer, heart failure, or kidney failure, you or your family may be eligible for a substantial financial recovery.

John Foy & Associates is one of the largest, most experienced medical injury law firms in the country. We believe patients have rights and that drugs should do what they say they do—without unexpected side effects. Let us discuss your case with you for free. Call us at 404-400-4000 and get your free consultation today.

What are Januvia and Janumet?

Januvia is the brand name of a diabetes drug called sitagliptin, made by Merck & Co. It’s part of a new class of diabetes drugs for type 2 diabetics. These drugs affect an enzyme called dipeptidyl peptidase-4 (DPP-4), and are known as DPP-4 inhibitors.

In type 2 diabetes, your body cannot produce enough insulin to process the glucose (blood sugar) in your blood. The conventional treatment is to give insulin injections, essentially supplying your body with the insulin it can’t make on its own. But DPP-4 drugs like Januvia take a different approach: they try to get the body to make more insulin on its own. That’s why they target DPP-4.

DPP-4 breaks down certain hormones in the pancreas. One of those hormones is responsible for stimulating insulin production. Essentially, DPP-4 is the “off switch” for insulin production. By inhibiting DPP-4, Januvia disables the off switch and forces the pancreas to produce higher levels of insulin.

While effective, however, it appears that the pancreas is not meant to be jammed in the “on” position. The side effects of Januvia and its cousin Janumet can be life threatening.

How do Januvia and Janumet cause pancreatic cancer?

The pancreas is a very sensitive organ. Like all organs in the body, if it comes under attack its natural response is to become inflamed. Inflammation is your body’s immune response to many kinds of threats, but long term, it can damage the very organs it is trying to protect. It would appear that the pancreas may perceive DPP-4 inhibitors as a threat and, in some cases, become inflamed—a condition known as pancreatitis.

Pancreatitis is very dangerous, because an inflamed pancreas will start to attack itself with its own digestive enzymes. These enzymes can end up destroying healthy cells and preventing the pancreas from producing crucial enzymes. Pancreatitis can come on suddenly or it can be a long, slow process. Both forms require medical attention and can be deadly.

The damage can also leave the pancreas wide open to other threats, such as pancreatic cancer. Pancreatic cancer is an aggressive, dangerous form of cancer that’s hard to detect in the early stages. It’s also hard to treat. Many cases of pancreatic cancer are incurable and result in death.

It is now understood that Januvia can cause pancreatitis, even years after taking it.

Has the FDA done anything about Januvia?

Yes. Not long after Januvia was put on the market, the FDA began receiving reports of pancreatitis and other complications among those who used it. After gathering information, the FDA decided in 2009 to change its warnings on Januvia. The FDA wanted patients to be aware of the risk, and wanted doctors to take appropriate steps when prescribing the drug—steps that Merck itself had not taken.

The agency also went back to Merck and told the company to conduct additional tests on Januvia and the risk of pancreatitis. They wanted enough information to decide if additional action was needed. Merck promised to conduct a study by June 2011, but when the deadline came, there was no study. The FDA issued a warning letter to Merck and, ultimately, launched an investigation in 2013.

During this time new independent studies emerged on the safety risks of Januvia. The most important of these was published in the Journal of the American Medical Association, and had shocking results:

Januvia may double the risk of being hospitalized for pancreatitis
The drug can cause changes in the pancreas known as pancreatic duct metaplasia, which can lead to cancer

Is Merck liable for the harm caused by Januvia?

Yes. Under U.S. law, pharmaceutical companies have a duty to thoroughly test their products for safety, warn the public of any potential side effects, and comply with the FDA. Merck flaunted these requirements, essentially ensuring that diabetics would be harmed or even lose their lives.

Lawsuits against Merck state that:

Merck did not adequately warn patients about potential side effects
Merck did not advise doctors about monitoring patients for signs of pancreatitis
Merck did not pull Januvia or Janumet from use, even when the dangers became clear

In legal language this is known as negligence. In plain English it’s called ruining lives. Merck is liable for the harm it caused.

How do I know if I have a Januvia/Janumet lawsuit?

If you took Januvia or Janumet and experienced acute pancreatitis, chronic pancreatitis, or pancreatic cancer—or if a loved one lost their life to one of these diseases—then you may have a case. The law says you have a right to a full financial recovery. This includes money for the cost of your treatment, hospitalization, medicine, lost wages and rehabilitation, or the expenses of a late departed one. There is no way for this money to undo the harm that was caused, but it can help your family recover economically and move on without debt.

The only way to be sure whether you have a case is to speak to a good attorney. At John Foy & Associates we know how to fight big companies and we have the track record to prove it. We will give you a free consultation and we charge you nothing unless we win you money. Let us help you. Call us at 404-400-4000 and get your FREE consultation today.

July 4, 2016 - Januvia has a New Competitor:

DPP-4 inhibitors are a class of diabetes drug that helps to increase insulin production in patients with type-2 diabetes. Popular DPP-4 inhibitors such as Januvia, known as Janumet overseas, have been linked with possible problems like pancreatitis and pancreatic cancer. However, DPP-4 inhibitors may be on the way out due to a new class of drug.

Januvia is an oral diabetes medication that earns Merck Pharmaceuticals $6 billion per year. In recent quarters, the growth for Januvia has accelerated due to the release of a study’s results presented at the American Diabetes Association and published in the New England Journal of Medicine. The study showed that Januvia met its goals of not increasing cardiovascular events compared to other DPP-4 inhibitors. The study, Trial Evaluating Cardiovascular Outcomes with Sitagliptin (the scientific name for Januvia), or TECOS, showed that there was no increase of major cardiovascular events requiring hospitalization versus the placebo.

However, DPP-4 inhibitor drugs have now met a competitor in SGLT-2 inhibitors, which work in the kidneys rather than in the pancreas. SGLT-2 inhibitors prevent the absorption of glucose in the kidneys and allow it to pass in the urine.

Eli Lilly and partner Boehringer International released a study in January concerning patients at high risk for a cardiovascular event and their brand of SGLT-2 inhibitors. The brand name of the drug, Jardiance, was shown to be superior to the current standard of care in the reduction of cardiovascular events. The study involved 7,000 adult type-2 diabetes patients considered to be at high risk for a cardiovascular event.

SLGT-2 inhibitor drugs also brought a welcome side effect of weight loss in some patients. DPP-4 inhibitors like Januvia/Janumet are weight neutral in contrast.

While it remains to be seen if SGLT-2 inhibitors will replace DPP-4 inhibitors, the FDA has released the caution that SGLT-2 inhibitors may cause a condition called ketoacidosis, or a build up of blood acids that causes hospitalization.

If you have been prescribed the diabetes drug known as Januvia, your health may have been put at risk. If you have suffered side effects or adverse health events as a result of the prescribed drug Januvia, you may be entitled to compensation. Contact the “Strong Arm” attorneys at John Foy & Associates. We may be able to help you get the compensation you deserve. Contact us today.