What is Januvia?
Januvia (generic: sitagliptin) is an oral medication that helps control blood sugar levels in patients with type 2 diabetes. The drug works by regulating levels of insulin the body produces after eating. Januvia is made by Merck & Co., and was approved by the U.S. Food & Drug Administration (FDA) in October 2006.
What’s the Problem?
Recent studies have established a potential link between the use of Januvia and the development of pancreatic cancer, one of the leading causes of cancer death among men and women in the U.S. If you or a loved one was diagnosed with pancreatic cancer after taking Januvia, contact our lawyers today to learn more about your legal rights.
How Can Januvia Cause Pancreatic Cancer?
Januvia belongs to a class of type 2 diabetes medications that work by slowing the metabolism of hormones called incretins – specifically Glucagon-Like Peptide-1 (GLP-1). Patients with type 2 diabetes do not produce enough GLP-1 on their own, and Januvia allows these hormones to stay active in the blood longer to lower blood sugar levels. In doing so, the drug increases the user’s GLP-1 receptor activity. However, this same mechanism of action may also increase the risk of pancreatic cancer.
Januvia Pancreatic Cancer Studies
A study published in the journal Diabetes in April 2009 found a link between Januvia and pancreatic abnormalities, which may increase the risk of pancreatitis and pancreatic cancer. The researchers also determined that many of the pancreatic risks associated with Januvia may be reduced when the drug is taken together with with metformin.
In a follow-up study published in Gastroenterology, researchers found a 6.7-fold increase of reported cases of pancreatitis and a 2.7-fold increase in pancreatic cancers reported in patients treated with Januvia, compared to 4 other type 2 diabetes medications. The study looked at data submitted to the FDA’s Adverse Events Reporting System database between 2004 and 2009.
In September 2009, FDA updated Januvia’s prescribing information to include reports of acute pancreatitis associated with the drug. The agency looked at 88 cases of acute pancreatitis in Januvia users reported to its adverse event reporting system from 2006 to 2009. Of these, 58 patients required hospitalization, 4 of whom ended up in the intensive care unit (ICU).
FDA threatened repercussions against Merck in 2011 after the company failed to complete a proposed animal study regarding the pancreatitis risk with Januvia. When the drug was approved in October 2006, FDA required the manufacturer to complete and publish the study by June 2011. Merck’s original design proposal was allegedly rejected by the FDA, and the company never revised it. Merck then allegedly submitted the findings of an independent study, which the agency did not consider valid. FDA demanded in February 2012 that Merck submit a new proposal and begin the study within 6 months. The results of that study have not been released.
In March 2013, FDA issued a Drug Safety Communication announcing that it was reviewing new research which suggested an increased risk for pre-cancerous cell chances and pancreatitis in patients who took Januvia and other similar type 2 diabetes medications. According to the agency, the findings were “based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes.”
Pancreatic Cancer Symptoms
Pancreatic cancer is currently the 4th leading cause of cancer death in the U.S., according to the American Cancer Society (ACS). Only 20% of patients diagnosed with the disease survive for a full year after diagnosis. Signs and symptoms of pancreatic cancer include:
- Abdominal pain
- Gastrointestinal distress
- Weight loss
- Ascites (increased abdominal fluid)
When pancreatic tumors spread, they typically migrate to the liver. This can enlarge the liver, which can cause pain and loss of appetite. It can also affect liver function, sometimes leading to jaundice (yellowing of the skin and eyes) and abnormal lab tests.
Tumors can also spread to other organs and tissues. Signs and symptoms depend on where the cancer is growing. For example, cancer spread to the lungs can cause shortness of breath and/or cough. Spread to bones can cause pain in those bones.
Januvia Side Effects
- Acute Pancreatitis
- Hemorrhagic Pancreatitis
- Necrotizing Pancreatitis
- Pancreatic Cancer
- Thyroid Cancer
- Heart Failure
- Gallbladder Disease
- Bile Duct Disease
- Joint Pain
Bile Duct / Gallbladder Disease
An August 2016 study published in JAMA Internal Medicine found that incretin-based type 2 diabetes medications like Januvia were linked to a 79% increased risk for bile duct and gallbladder disease. The primary adverse event associated with the drugs was gallstones, which are painful but treatable. In a subsequent analysis, the researchers found a doubled increased rate of gallbladder removal surgery, which is a common treatment for painful gallstones.
Januvia has also been linked to an 84% increase in hospitalization for heart failure, according to a study published in JACC Heart Failure in December 2014. Conclusions were based on data from 7,620 patients with diabetes and incident heart failure, of whom 887 were treated with Januvia. Overall, Januvia users did not have higher rates of hospitalization or death. However, they were significantly more likely to be hospitalized with heart failure — 12.5% vs. 9% who did not take the medication.
FDA warned in August 2015 that Januvia and other similar diabetes drugs may cause severe, debilitating joint pain. The agency received at least 28 reports of joint pain in patients treated with Januvia from 2006 to 2013. Some patients had to be hospitalized because symptoms were so severe. Most patients recovered after quitting the drug, but in some cases symptoms persisted even after discontinuing treatment.
In August 2013, all federal lawsuits alleging injuries from Januvia and other incretin mimetic diabetes drugs were consolidated into a multidistrict litigation (MDL No. 2452) in the U.S. District Court for the Southern District of California. As of January 2016, the MDL included at least 750 lawsuits.
October 2006 – Approved by the FDA
October 17, 2006 – Januvia approved by the FDA
April 2009 – Diabetes study published
April 2009 – Study published in Diabetes finds a link between the use of Januvia and pancreatic abnormalities.
September 2009 – FDA updates Januvia info
September 25, 2009 – FDA updates Januvia prescribing information with data about reports of pancreatitis in Januvia users.
June 2011 – FDA threatens to impose sanctions
June 2011 – FDA threatens Merck with sanctions after the company fails to complete a study looking at the pancreatitis risk with Januvia.
July 2011 – Gastroenterology follow-up study published
July 2011 – Follow-up study published in Gastroenterology finds increased reports of pancreatitis and pancreatic cancer in patients who took Januvia.
February 2012 – FDA requirement
February 2012 – FDA requires Merck to submit a new proposal for the Januvia animal study it was supposed to complete in 2011.
August 2013 – MDL created
August 2013 – MDL created for federal lawsuits alleging injuries from incretin mimetic diabetes drugs.
December 2014 – JACC Heart Failure study published
December 2014 – Study published in JACC Heart Failure links Januvia use to an 84% increased risk of hospitalization for heart failure.
March 2015 – FDA Drug Safety Communication announced
March 14, 2015 – FDA Drug Safety Communication announces new research suggesting an increased risk for pre-cancerous cell chances and pancreatitis in patients who took Januvia and other similar drugs.
August 2015 – FDA warning
August 28, 2015 – FDA warns of reports of “severe and debilitating” joint pain associated with Januvia and other similar type 2 diabetes medications.
August 2016 – JAMA Internal Medicine study findings
August 1, 2016 – JAMA Internal Medicine study finds increased risk of bile duct and gallbladder disease associated with incretin-based diabetes drugs.
- “FDA Approves New Treatment for Diabetes: First in a New Class of Diabetes Drugs”. U.S. Food & Drug Administration (FDA). October 17, 2006.
- “Beneficial Endocrine but adverse Exocrine effects of Sitagliptin in the HIP rat model of Type 2 Diabetes, interactions with Metformin”. American Diabetes Association (ADA). April 2009.
- “Information for Healthcare Professionals – Acute pancreatitis and sitagliptin (marketed as Januvia and Janumet)”. U.S. Food & Drug Administration (FDA). September 25, 2009.
- “Pancreatitis, pancreatic, and thyroid cancer with glucagon-like peptide-1-based therapies”. Gastroenterology. July 2011.
- “FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes”. U.S. Food & Drug Administration (FDA). March 14, 2013.
- “In Re: Incretin Mimetics Products Liability Litigation MDL”. United States District Court, Southern District of California. August 26, 2013.
- “Sitagliptin Use in Patients With Diabetes and Heart Failure”. JACC Heart Failure. December 2014.
- “DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication – May Cause Severe Joint Pain”. U.S. Food & Drug Administration (FDA). August 28, 2015.
- “Association of Bile Duct and Gallbladder Diseases With the Use of Incretin-Based Drugs in Patients With Type 2 Diabetes Mellitus”. JAMA Internal Medicine. August 1, 2016.
- “Pancreatic Cancer”. American Cancer Society (ACS).