Januvia May Cause Pancreatic Cancer and Death, Lawsuits Allege

Hundreds have taken legal action against Merck & Co. alleging that the company’s type 2 diabetes drug Januvia puts patient at an increased risk of developing life-threatening pancreatic cancer. According to these lawsuits, Januvia is defective and unreasonably dangerous, is harmful to human health, and lacks proper warnings of the drug’s dangers – specifically the risk of pancreatic cancer. The plaintiffs allege that Merck & Co. knew or should have known that Januvia could cause this deadly form of cancer, and are now seeking compensation from the pharmaceutical company for medical bills, funeral expenses and other damages.

What Are the Lawsuits Saying About Januvia?

The plaintiffs allege that Januvia is defective, unreasonably dangerous and unsuited for its ordinary purpose because its risks outweigh its benefits. The lawsuits also allege:

These plaintiffs are seeking compensation for the cost of medical bills, lost wages, and pain and suffering. While some plaintiffs are representing themselves, others are acting on a loved one’s behalf, and have filed wrongful death lawsuits seeking compensation for funeral expenses and loss of projected income.

What About Janumet?

Janumet, a combination drug containing both Januvia (sitagliptin) and another type 2 diabetes medication known as metformin, has also been included in the federal multidistrict litigation over incretin mimetic drugs. While Janumet contains metformin, which belongs to a separate class of drugs, it has also been linked to pancreatic cancer and there is no reason to believe that Janumet may be any safer than Januvia.

Is This a Class Action Lawsuit?

The Januvia lawsuits will not proceed as a class action. This means that each patient who was diagnosed with pancreatic cancer after using Januvia will have to file a separate lawsuit with his or her own attorney. At ClassAction.org, we can help clients get in contact an attorney who may be able to assist them with filing a lawsuit.

In August 2013, the Januvia lawsuits were transferred to the U.S. District Court Southern District of California as part of a procedure known as multidistrict litigation (MDL). In the MDL, all federal lawsuits involving incretin mimetic drugs Januvia, Janumet, Byetta and Victoza and their link to pancreatic cancer will be overseen by the same judge – the Honorable Judge Anthony J. Battaglia. Even though the suits have been consolidated, each plaintiff will retain his or her own attorney, suit and right to an individual award.

How Can Januvia and Janumet Cause Pancreatic Cancer?

It is believed that the way Januvia and other incretin mimetic drugs work to lower a diabetic’s blood sugar levels may cause pancreatitis (inflammation of the pancreas), which may lead to pancreatic cancer.

Many diabetics suffer from high blood sugar levels because their bodies are resistant to the effects of insulin, a hormone that the pancreas produces to transport glucose (sugar) from the bloodstream to the body’s cells. Drugs including Januvia belong to a new class of type 2 diabetes drugs known as incretin mimetics, which work to lower blood sugar levels by controlling the gastrointestinal hormone responsible for releasing insulin: glucagon-like peptide-1 (GLP-1). While some incretin mimetics such as Byetta increase insulin levels by mimicking GLP-1, Januvia increases insulin levels by slowing down the metabolic process of GLP-1. Januvia does so by inhibiting dipeptidyl-peptidase-4 (DPP-4), an enzyme that quickly metabolizes GLP-1.

Regardless of which incretin mimetic is used, both types still produce higher levels of insulin by increasing GLP-1 receptor activity. Unfortunately, it is believed that the effect incretin mimetic drugs have on GLP-1 receptor activity may increase a patient’s risk of developing pancreatic cancer.

Januvia Linked to Pancreatitis, Pancreatic Cancer in Studies

Since the first incretin mimetic drug was approved by the FDA in 2005, various studies have linked these medications to pancreatitis and pancreatic cancer. One of the first studies to suggest a link between Januvia and pancreatic cancer was performed by researchers at UCLA who found that rats exposed to Januvia suffered from pancreatitis and developed abnormalities of the pancreas – both of which are risk factors for pancreatic cancer in humans. The study, published in the journal Diabetes in 2009, said that elevated levels of the hormone GLP-1 seemed to be responsible for these conditions.

In 2011, the same group of researchers reviewed the FDA’s Adverse Event Reporting System for negative side effects reported by Januvia users and published their results in the journal Gastroenterology. These researchers concluded that patients using Januvia experienced a 6.7-fold increased rate of pancreatitis and a 2.7-fold increased rate of pancreatic cancer when compared to those using different type 2 diabetes medications.

Has the FDA Addressed Problems with Januvia?

Yes. The FDA first published a post-market drug safety information notice on Januvia and Janumet in 2009 to alert the public that it would be revising the prescribing information for these drugs to include the risk of acute pancreatitis. According to the FDA, a review of post-marketing reports found 88 cases of the problem, two of which were hemorrhagic or necrotizing pancreatitis, a potentially fatal condition that causes liver inflammation.

Following its announcement, the FDA requested that Merck & Co. perform a follow-up study on the risk of pancreatitis in Januvia patients; however, Merck & Co. failed to meet its deadline for submitting further research and the FDA sent the company a warning letter in 2012 demanding a response and a follow-up study once again.

In 2013, the FDA revisited the subject in a safety communication, saying that it would be reviewing unpublished findings from a new study suggesting a link between incretin mimetic drugs and pancreatitis and pancreatic duct metaplasia (pre-cancerous cellular changes). While the FDA did not reach any conclusions at the time, it said that it would continue to evaluate this new information.

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