Merck’s popular type 2 diabetes drug Januvia (generic: sitagliptin) has recently been linked to pancreatitis, pancreatic cancer, and a severe skin disorder known as bullous pemphigoid.
Free Confidential Lawsuit Evaluation: If you or a loved one has been diagnosed with pancreatic cancer after taking Januvia, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: DPP-4 Inhibitors Linked to Rhabdomyolysis
December 1, 2017 - Januvia and other type 2 diabetes drugs from the DPP-4 inhibitor class have been linked to reports to a severe muscular disease called rhabdomyolysis, according to the FDA Adverse Event Reporting System (FAERS). Rhabdomyolysis is as condition in which the skeletal muscle breaks down rapidly, causing symptoms such as fever, nausea, confusion, malaise and dark-colored urine.
Manufactured and marketed by Merck & Co., Januvia is a widely-prescribed medication used to help lower blood sugar levels in individuals with type 2 diabetes. The drug works by increasing insulin production in response to food intake and decreasing the amount of sugar that the liver produces. Januvia is part of a class of diabetes medications called dipeptidyl peptidase-4 (DPP-4) inhibitors that break down incretin hormones. As a DPP-4 inhibitor, Januvia slows the breakdown of incretin hormones, thereby increasing the level of these substances in the body. This, in turn, increases insulin production in response to meals and decreases the amount of glucose (sugar) that the liver produces. Januvia was approved by the FDA in October 2006.
On September 25, 2009, the FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia and Janumet to include information regarding numerous cases of acute pancreatitis in patients using these products. At the time of the warning, at least 88 post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the administration between October 2006 and February 2009.
The FDA has asked Merck to update its Januvia warning label to reflect these new dangers and include:
- Information regarding post-marketing reports of acute pancreatitis, including the severe forms, hemorrhagic or necrotizing pancreatitis.
- Recommending that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin, and to discontinue sitagliptin or sitagliptin/metformin if pancreatitis is suspected while using these products.
- Information noting that sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis while using sitagliptin or sitagliptin/metformin.
- Sitagliptin or sitagliptin/metformin should be used with caution and with appropriate monitoring in patients with a history of pancreatitis.
What is Pancreatitis?
Pancreatitis occurs when the pancreas becomes inflamed. The pancreas is a large gland behind the stomach that secretes digestive juices (enzymes) into the duodenum through a tube called the pancreatic duct. Pancreatic enzymes then join with bile - a liquid produced in the liver and stored in the gallbladder - to break down foodstuffs. Normally, digestive enzymes secreted by the pancreas do not become active until they reach the small intestines. But when Januvia pancreatitis develops, the enzymes inside it attack and damage the tissues that produce them. Pancreatitis can be acute, hemorrhagic, necrotizing, or chronic.
Signs and symptoms of acute pancreatitis may include:
- Upper abdominal pain
- Abdominal pain that radiates to your back
- Abdominal pain that feels worse after eating
- Tenderness when touching the abdomen
Chronic pancreatitis signs and symptoms include:
- Upper abdominal pain
- Losing weight without trying
- Oily, smelly stools (steatorrhea)
Symptoms of hemorrhagic pancreatitis may include:
- Flu-like symptoms
- High fever
- Clay-colored stools
Necrotizing pancreatitis may be manifested through the following:
- Drop in blood pressure
- Pain in the upper abdominal region
Over time, pancreatitis can lead to pancreatic cancer, the 4th leading cause of cancer death in the U.S. Only 20% of Americans diagnosed with the disease survive for a full year, according to the American Cancer Society. In March 2013, the FDA announced that it was investigating incretin mimetics for evidence that they cause pancreatic cancer.
Signs and symptoms of pancreatic cancer include:
- Abdominal pain
- Gastrointestinal distress
- Weight loss
- Ascites (increased abdominal fluid)
Januvia Side Effects
- Acute Pancreatitis
- Hemorrhagic Pancreatitis
- Necrotizing Pancreatitis
- Pancreatic Cancer
- Thyroid Cancer
Study Highlights Risks of Combining Januvia with Other Diabetes Drugs
June 23, 2016 - A new study published in the British Medical Journal (BMJ) has found that combining DPP-4 inhibitors like Januvia with “sulphonylureas” may increase the risk of hypoglycemia (low blood sugar), a potentially life-threatening condition.
DPP-4 Inhibitors and Bullous Pemphigoid
In October 2016, the FDA asked manufacturers of DPP-4 inhibitor diabetes drugs to add a label change to their products regarding an increased risk of bullous pemphigoid (BP), a rare skin disorder that causes symptoms of blistering on the arms, legs, abdomen, and mucous membranes. All patients who developed the disease had severe outcomes, including one person who died from complications. As a result of these problems, FDA required a class-wide label change to reflect the risk of bullous pemphigoid with DPP-4 inhibitors.
Merck Shares Slump as Januvia Sales Decline
February 5, 2016 - Merck & Co. reported lower-than-expected quarterly revenue, largely the result of slumping sales of Januvia, according to Fortune. Januvia sales fell 12% to $1.45 billion in the 4th quarter while sales of the arthritis drug Remicade (generic: infliximab) fell 29% to $396 million. Merck's total revenue fell 2.5% to $10.22 billion over the same time period, according to Reuters.
DPP-4 Inhibitors Linked to Severe Joint Pain: FDA Warning
August 28, 2015 - The FDA is warning that Januvia and other type 2 diabetes medications from the DPP-4 class may cause severe and debilitating joint pain in some users. Symptoms began from one day to several years after taking the drugs, and most resolved in less than a month after discontinuing use.
Has There Been a Recall?
To date, no recall has been issued for Januvia in the U.S. or any other country. However, injured parties may still be able to file a product liability lawsuit against the drug's manufacturer. If our lawyers determine that you have a valid claim, you may be eligible to receive compensation for medical expenses, lost wages, pain and suffering, and more. Contact us today to learn more about your legal rights.
Allegations raised in Januvia lawsuits accuse the manufacturer of:
- Failing to adequately warn about the drug's potential adverse effects;
- Failing to advise doctors about the importance of monitoring the pancreases of patients who have been prescribed Januvia, and
- Failing to issue a Januvia recall after it became apparent that the risks of the medication outweigh its potential benefits compared to other diabetes drugs.
Do I Have a Januvia Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Januvia lawsuits. We are handling individual litigation nationwide and currently accepting new pancreatic cancer cases in all 50 states.
Free Confidential Case Evaluation: Again, if you got pancreatic cancer from Januvia, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and we can help.