Every year, Janumet and its sister drug Januvia bring in billions of dollars for drugmaker Merck & Co. That’s because millions of people with type 2 diabetes depend on the drugs to help them control their blood sugar levels.
What many people who take Janumet don’t know is that the diabetes drug carries side effects that could have long-lasting and sometimes lethal consequences for users. Janumet has been connected to several cases of severe complications, such as debilitating joint pain, acute pancreatitis, and different kinds of cancer.
Hundreds of victims who developed complications while taking Janumet and similar type 2 diabetes drugs have come forward to hold drugmakers accountable for selling potentially deadly medications.
Find out how the active ingredients of Janumet might be causing pancreatic diseases and what accusations plaintiffs are making against Merck.
Janumet is a type 2 diabetes drug made by Merck that contains sitagliptin and metformin. Sitagliptin belongs to a class of drugs known as dipeptidyl peptidase 4 (DPP-4) inhibitors.
According to the prescribing information sheet for Janumet, sitagliptin works by stopping the enzyme DPP-4 from inactivating incretin hormones like glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). By allowing GLP-1 and GIP to function intact, the drug stimulates the pancreas to make more insulin and thereby normalizing blood glucose levels.
Metformin works to improve glycemic control in a complementary way. The drug suppresses liver glucose production and decreases the intestinal absorption of glucose. Unlike DPP-4 inhibitors, metformin does not increase insulin secretion.
Janumet’s recommended starting dose for patients is either 50 mg sitagliptin and 500 mg metformin hydrochloride or 50 mg sitagliptin and 1000 mg metformin hydrochloride, depending on the patient’s current regimen. Janumet should be taken twice a day with meals.
Janumet XR is an extended-release version of the drug that’s designed to be taken once a day.
Janumet was approved by the U.S. Food and Drug Administration in 2007 — just a year after the first sitagliptin-containing drug Januvia was approved.
When Janumet was announced by Merck, it was touted as a type 2 diabetes medication with “proven efficacy.”
“Janumet is an important new treatment option for many patients who need more than one therapy to control their type 2 diabetes because it addresses all three key defects of type 2 diabetes for improved glycemic control,” Dr. Nir Barzilai, director of the Institute for Aging Research, Albert Einstein College of Medicine, said in a press release.
Along with Januvia, Janumet was projected to become a blockbuster diabetes drug that would bring in billions of dollars for Merck. Worldwide sales were $3.3 billion for Januvia and $1.36 billion for Janumet in 2011. Sales were bolstered even more when Merck announced that the FDA had approved a new extended-release formula of the combination drug in February 2012.
Janumet XR was touted as another breakthrough drug that offered convenience and success at managing blood sugar levels.
“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, a vice president at Merck, said in a press release 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.”
Januvia and Janumet brought in more than $6 billion in revenue for 2014. Despite facing growing competition in 2018, Janumet remains one of the top-selling diabetes drugs in the world.
Within weeks of approval by the FDA, patients taking Janumet and Januvia began reporting a bevy of unexpected side effects to the regulatory agency.
One of the first reported side effects of sitagliptin was acute pancreatitis. Acute pancreatitis is when the pancreas becomes suddenly and severely inflamed. According to The National Pancreas Foundation, the mortality rate of acute pancreatitis remains at about 10 percent.
The FDA received 88 cases of acute pancreatitis reported to its Adverse Event Reporting System (AERS) between October 2006 and February 2009. More than half of the patients were hospitalized, and four were admitted to the intensive care unit. Two patients had hemorrhagic or necrotizing pancreatitis and needed extensive hospitalization. In more than 20 percent of the cases, pancreatitis occurred within a month of starting Januvia or Janumet.
Based on the reports, the FDA made an association between the use of sitagliptin and acute pancreatitis. This resulted in the FDA updating the labels of Januvia and Janumet in 2009 to include information about the cases of acute pancreatitis.
“Because acute pancreatitis is associated with considerable morbidity and mortality, and early recognition is important in reducing adverse health outcomes, FDA is recommending revisions to the prescribing information to alert healthcare professionals to this potentially serious adverse drug event,” the FDA said.
Acute pancreatitis can lead to life-threatening complications if left untreated. In some cases, multiple organs could fail.
Symptoms may include:
Studies on the link between sitagliptin and pancreatitis also noted a connection between the diabetes drug and pancreatic cancer.
A 2013 study published in JAMA Internal Medicine found that GLP-1- based therapies like Janumet double the risk of being hospitalized for acute pancreatitis. More notably, lead researcher Dr. Sonal Singh said that “pancreatitis is on the pathway toward pancreatic cancer.”
The study prompted the FDA to announce it was evaluating information that may connect type 2 diabetes drugs with pancreatic cancer. In a joint statement, the American Association of Clinical Endocrinologists and the American Diabetes Association refuted the study and defended the drugs.
In 2014, the FDA and the European Medicines Agency issued a joint assessment that incretin-based drugs like Janumet did not increase the risk of pancreatic cancer.
“Both agencies agree that assertions concerning a causal association between incretin-based drugs and pancreatitis or pancreatic cancer, as expressed recently in the scientific literature and in the media, are inconsistent with the current data,” they wrote.
Researchers have urged a more in-depth exploration into the connection between pancreatic cancer and sitagliptin.
Not long after the FDA announced a connection between Janumet and pancreatitis, patients who developed pancreatic diseases while taking Janumet and similar type 2 diabetes drugs started filing lawsuits. Plaintiffs claimed that the drugmakers designed a defective drug and failed to warn patients and healthcare professionals of the risks.
By 2013, more than 50 cases were pending across seven districts. In August 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) agreed to centralize all cases involving four incretin-based medications — Janumet, Januvia, Byetta, and Victoza — into a single federal docket for the sake of judicial efficiency.
There were 948 pending cases in the Incretin-Based Therapies Products Liability Litigation in California as of September 2018, according to the JPML.
Although the cases were temporarily thrown out in 2015, an appeals court reinstated the cases and allowed them to proceed in 2017.
Hundreds of cases are being filed by family members of patients that have died of pancreatic cancer while taking the drugs. In one case, a man was prescribed Janumet to help him treat type 2 diabetes. Three years later, he was diagnosed with pancreatic cancer. He underwent surgeries to treat his cancer but eventually died a few months later.
His wife is suing Merck over claims that the company knew or should have known about the risks, failed to warn the public, and negligently sold the drugs.
In some cases, those who died of pancreatic cancer had taken one or more of Janumet, Januvia, Byetta, and Victoza. However, the plaintiffs in nearly every case have similar stories and allegations.
If you or a loved one have been diagnosed with a pancreatic disease after taking Janumet or another type 2 diabetes drug, you should contact an experienced attorney immediately to find out whether you could receive compensation and hold drugmakers accountable.
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