When Januvia was first approved to help those with type 2 diabetes control their blood sugar levels, it ushered in a new class of drugs known as dipeptidyl peptidase 4 (DPP-4) inhibitors. Januvia and other DPP-4 inhibitors were touted as better alternatives to existing drugs on the market.
Within weeks of Januvia’s approval in 2006, the U.S. Food and Drug Administration began receiving reports that patients taking the drug were developing severe and sometimes lethal side effects, such as pancreatitis and pancreatic cancer.
Now, nearly a thousand lawsuits have been filed against drugmaker Merck & Co. and other manufacturers of similar type 2 diabetes drugs over claims that the companies concealed the risks from the public and made defective drugs.
Find out why so many people are filing Januvia lawsuits and how the drug has affected patients.
What is Sitagliptin?
Sitagliptin is the active ingredient of type 2 diabetes Januvia. It was developed by Merck & Co.
Januvia belongs to a class of drugs called dipeptidyl peptidase 4 (DPP-4) inhibitors. Sitagliptin and other DPP-4 inhibitors work by stopping the DPP-4 enzyme from functioning. This enzyme breaks down hormones called incretins — specifically the GLP-1 and GIP hormones. Incretins are released into the body after eating a meal.
By stopping DDP-4 from breaking down the incretins, Januvia allows the pancreas to make more insulin to secrete into the blood and help normalize blood sugar levels.
Januvia comes in a pill at 25 mg, 50 mg, and 100 mg. The recommended starting dose is 100 mg taken once a day with or without food. Those with kidney problems may start at the smaller doses. It is prescribed along with diet and exercise.
Januvia was first approved by the FDA in 2006. At the time, it was the third big new diabetes drug approved by the agency in the previous year. Even at the time, it was believed to become a blockbuster new drug that would be used by millions around the world1.
“The approval of Januvia marks an important advance in the fight against diabetes,” Steven Galson, Director of FDA’s Center for Drug Evaluation and Research, said at the time. “We now have another new option that treats the disease in an entirely new way that can be added to existing treatment regimens to help patients gain more control over their blood sugar levels.”
Doctors were particularly excited to try the drug because of its advantages over existing drugs on the market then.
“I can’t wait to put people on the drug,” Dr. James Underberg, a clinical assistant professor at New York University medical school who participated in a Januvia clinical trial, told The New York Times2. “It doesn’t cause weight gain, it doesn’t cause episodes of hypoglycemia, and the side effects otherwise are pretty moderate.”
It was estimated to have worldwide sales of nearly $2 billion by 2010.
In 2007, the FDA approved another version of the drug called Janumet, which is a combination of sitagliptin and metformin. Four years later, an extended-release version of Janumet was released.
To say the drug was successful is an understatement. Januvia and Janumet have brought in billions of dollars for Merck and is expected to continue to bring in billions until generic versions start appearing after 2022.
Serious Januvia Side Effects
Although Januvia was initially praised for having fewer severe side effects than existing diabetes drugs at the time, the FDA started receiving reports of serious side effects.
One of the first serious complications associated with Januvia was pancreatitis. Pancreatitis is the inflammation of the pancreas, an organ in the digestive system that helps regulate sugar levels in the blood. This type of inflammation can occur as acute pancreatitis or chronic pancreatitis.
Acute pancreatitis carries a massive risk because its symptoms come on quickly and can damage the pancreas. If left unchecked, acute pancreatitis can lead to a loss of function of the pancreas, infection, kidney failure, and even death.
The FDA started receiving reports of pancreatitis in patients taking Januvia as early as October 2006. Between then and February 2009, 88 cases of acute pancreatitis were reported to the FDA via its MedWatch reporting program. Of those 88 cases, two suffered hemorrhagic or necrotizing pancreatitis that needed extensive hospitalization. Four patients were admitted to the intensive care unit.
As a result, the FDA announced in September 2009 that it was revising the prescribing sheet for products with sitagliptin to include information about post-marketing cases of acute pancreatitis. It also warned physicians to keep an eye out for symptoms in Januvia patients.
Symptoms of Acute Pancreatitis:
- Severe abdominal pain
- Rapid pulse
- Swollen abdomen
- Pain radiating from back
Along with cases of pancreatitis, studies began linking sitagliptin with pancreatic cancer. In 2009, a study published in the journal Diabetes found that sitagliptin may increase the risk of developing pancreatitis and pancreatic cancer3.
In March 2013, the FDA issued a safety communication notifying the public that it was evaluating unpublished new findings that connected diabetes drugs like Januvia with an increased risk of pancreatitis and pancreatic cancer.
“FDA has not reached any new conclusions about safety risks with incretin mimetic drugs,” the agency announced. “This early communication is intended only to inform the public and healthcare professionals that the Agency intends to obtain and evaluate this new information.”
The agency later reaffirmed the safety of the drugs.
Januvia has also been linked to thyroid cancer. There have been fewer reported cases among those taking sitagliptin, but studies have made a connection.
A 2011 study in Gastroenterology found a few cases of people developing thyroid cancer after taking Januvia4. Other type 2 diabetes drugs like Victoza and Byetta have also been linked to thyroid cancer.
Lawsuits Filed Against Merck and Other Drugmakers
The first lawsuits against Januvia maker Merck came after the FDA changed the prescription sheet to include information about pancreatitis in 2009. In the following years, hundreds of additional patients who developed pancreatitis and pancreatic cancer after taking type 2 diabetes drugs like Januvia have filed lawsuits.
These are just some of the claims made in the lawsuits:
- The drugmakers failed to adequately test the type 2 diabetes medications before selling them.
- The drugmakers concealed the risks of pancreatitis and pancreatic cancer from the public.
- Current labels for the drugs do not adequately reflect the risks.
- The drugmakers failed to warn the public and healthcare professionals about the risks.
- Formulations for the type 2 diabetes drugs are defective.
In several cases, family members have filed wrongful death lawsuits after loved ones died of pancreatic cancer after taking Januvia and similar type 2 diabetes drugs.
Is There a Januvia Class-Action Lawsuit?
No. In cases of defective drugs, attorneys do not pursue a class-action lawsuit and will instead file individual claims.
However, if enough people file claims making similar allegations, all the cases can be consolidated into multidistrict litigation (MDL) to speed up the legal process. That’s what happened with more than 50 cases against Merck and other drugmakers.
The U.S. Judicial Panel on Multidistrict Litigation found that all the cases dealt with similar questions of fact and so should be consolidated into a single federal court. Since that decision in August 2013 to transfer all the cases to the U.S. District Court for the Southern District of California, hundreds of other lawsuits have been added to the MDL.
Hundreds of Januvia Cases Currently Pending
According to the Judicial Panel on Multidistrict Litigation, 948 cases are currently pending in the incretin mimetics drug MDL that includes Januvia lawsuits.
Defendants initially tried to get the cases in the MDL dismissed on the basis that state tort claims are void if a federal agency like the FDA would not have taken further action to update drug labels. A judge agreed to throw out the cases in 2015, but the cases in the MDL were reinstated by an appeals court after a panel decided to vacate the ruling in December 20175.
Since cases against Merck and other drugmakers are proceeding in the MDL, lawyers across the country are continuing to look for patients who developed pancreatic diseases while taking Januvia. Those who were victims of unexpected side effects while using Januvia should contact an attorney for legal advice immediately.