Since its approval by the U.S. Food and Drug Administration in 2006, Januvia has become one of the most popular drugs to help treat type 2 diabetes. Each year, the medication brings in billions of dollars for manufacturer Merck & Co.
While Januvia has helped countless people control their blood sugar levels by stimulating the pancreas to release more insulin, a growing number of people have reported unexpected side effects like pancreatitis, pancreatic cancer, and thyroid cancer.
Hundreds of victims of Januvia side effects have filed lawsuits in courts around the country. Nearly a thousand people have cases pending in multidistrict litigation against Merck & Co. over claims that the company — along with other makers of similar type 2 diabetes drugs — concealed the risks from the public and made defective drugs.
Learn more about how Januvia works and the status of Januvia lawsuits.
Januvia is a drug manufactured by Merck & Co. to treat type 2 diabetes. Januvia, whose active ingredient is sitagliptin, belongs to a class of drugs called dipeptidyl peptidase 4 (DPP-4) inhibitors. DPP-4 inhibitors work by stimulating the body to produce more insulin to control blood sugar levels.
Approved for use by the FDA in October 2006, Januvia was the first DDP-4 inhibitor to make it to market. The first tablets were approved for use by adult patients with type 2 diabetes in conjunction with diet and exercise to improve glycemic control. Not long after, the FDA approved another drug containing sitagliptin called Janumet. This newer medication is a combination of sitagliptin and metformin.
In February 2012, Merck announced that Janumet XR — an extended release formula — had been approved by the FDA.
“Janumet XR is a new treatment that adds once-daily convenience to the powerful efficacy of Janumet for patients with type 2 diabetes,” Dr. Barry J Goldstein, the vice president of diabetes and endocrinology at Merck said at the time. “This is important because many patients with type 2 diabetes require treatment with multiple drugs to maintain blood sugar control, and Janumet XR is a new option to help more patients get to their glucose goals.”
Since its release, Januvia has become one of the most popular drugs for type 2 diabetes. In 2015, Januvia generated about $6 billion in annual sales for Merck1. At the time, forecasters estimated sales to hit $7.1 billion by 2018.
Januvia is taken orally once a day. It comes in tablets of 25 mg, 50 mg, and 100 mg. The recommended starting dose is 100 mg once a day to be taken with or without food. However, the smaller doses may be recommended for those with kidney problems.
Sitagliptin works by stopping the enzyme DPP-4 from breaking down certain incretins in the intestines. By allowing the specific incretins to go inhibited, insulin levels are increased in the body. This helps the body control blood sugar levels.
“By increasing and prolonging active incretin levels, sitagliptin increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner,” according to the prescribing information sheet2.
Januvia carries some common side effects reported in at least 5 percent of patients treated with the drug.
Other common Januvia side effects people have experienced are a stuffy nose, sore throat, back pain, joint pain, nausea, diarrhea, constipation, and stomach pain3.
Aside from the typical side effects, sitagliptin has been linked to other, more severe complications. Patients taking the drugs have reportedly developed cases of acute pancreatitis.
According to the National Institute of Diabetes and Digestive and Kidney Diseases, pancreatitis is inflammation of the pancreas4. Acute pancreatitis is a short-term but severe case of inflammation that can be deadly if not treated right away.
Symptoms of acute pancreatitis can be fever, pain in the upper abdomen, nausea, and rapid pulse. These symptoms can be sudden and fatal. If left untreated, the inflammation could damage tissue, cause infection, and even spread to other organs. The mortality rate of acute pancreatitis can be more than 20 percent5.
The FDA started receiving reports of acute pancreatitis in those taking Januvia not long after the medication was introduced. Between October 2006 and February 2009, the regulatory agency received 88 reports of post-marketing cases of acute pancreatitis in patients using sitagliptin. Two patients required extensive hospitalization with hemorrhagic or necrotizing pancreatitis.
This prompted the FDA to issue a warning to healthcare professionals and patients in 2009 about Januvia’s connection to acute pancreatitis and to revise the prescribing information.
“Based on the temporal relationship of initiating sitagliptin or sitagliptin/metformin and development of acute pancreatitis in the reviewed cases, FDA believes there may be an association between these events,” the FDA wrote at the time.
Over time, Januvia was linked to even more complications, including different kinds of cancers.
Studies backed up reports submitted to the FDA that sitagliptin was associated with a higher risk of pancreatic cancer. In one 2016 study in the European Journal of Clinical Investigation, researchers analyzed thousands of users of sitagliptin to see whether there was a higher risk6.
“Sitagliptin is significantly associated with a higher risk of pancreatic cancer, especially when the cumulative dose is
< 33 700 mg,” the authors concluded. “The risk diminished in users with a higher cumulative dose.”
In 2013, the FDA announced it was looking into a study that suggested an increased risk of pancreatic cancer in those taking sitagliptin and other type 2 diabetes drugs.
“The U.S. Food and Drug Administration (FDA) is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics,” the FDA announced
By 2014, the FDA claimed that the evidence did not support a link to pancreatic cancer.
More recent studies have found a link between sitagliptin and thyroid cancer. In 2016, a study published in Oncotarget concluded that “sitagliptin use is associated with an increased risk of thyroid cancer” among Asian populations8.
Shortly after the FDA announcement linking diabetes drugs like Januvia to pancreatitis, victims started coming forward to file lawsuits against Merck.
People claimed that Merck knew about the risks but failed to warn the public and had manufactured a defective drug that causes unexpected side effects.
What started as lawsuits scattered in courts across the country later turned into multidistrict litigation. In August 2013, the U.S. Judicial Panel on Multidistrict Litigation consolidated dozens of cases against Merck and other drugmakers into a single federal court in California.
The goal of consolidating cases into a single MDL is to expedite the legal process and allow similar cases to be lumped together.
According to the JPML, there were 948 pending actions in the MDL called Incretin-Based Therapies Products Liability Litigation as of September 2018. However, the MDL underwent some challenges.
Merck and the other defendants filed a motion to dismiss all cases in the MDL under the FDA preemption legal theory, which says that state tort claims could not be pursued against FDA-approved products. A judge initially granted the request in 2015, but the plaintiffs appealed the decision.
In late 2017, a federal appeals court reinstated the MDL, overturning the initial ruling. The cases were allowed to proceed.
Lawsuits against Merck and other type 2 diabetes drugmakers make several allegations. For example, lawsuits claim that Januvia increases the risk of pancreatic cancer. Some even argue that the manufacturers concealed the dangers of pancreatitis and pancreatic cancer from the public.
In one case, a woman named Robin Tasler filed a wrongful death suit after she alleges her mother died of pancreatic cancer after taking type 2 diabetes drugs, including Januvia. Tasler is suing over a failure to warn, design defect, negligence, fraudulent concealment, and more.
Her case is not unlike hundreds of other filed against Januvia and other drugs like Byetta. Those who have suffered unexpected pancreatic diseases after taking Januvia may be entitled to compensation.
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