Update: Diabetes Drugs Linked to Rhabdomyolysis
December 1, 2017 – Januvia and other diabetes drugs in its class have been associated with a rare, life-threatening muscular disease called rhabdomyolysis, according to the FDA Adverse Event Reporting System (FAERS). Rhabdomyolysis occurs when the skeletal muscle breaks down rapidly, causing symptoms such as fever, nausea, confusion, malaise and dark-colored urine.
What is Januvia?
Januvia (sitagliptin) is a type-2 diabetes drug that was approved by the U.S. Food and Drug Administration (FDA) in 2006. It belongs to a class of medications called dipeptidyl peptidase-4 inhibitors, which treat diabetes by increasing levels of the hormone insulin.
What is the problem?
In September 2009, the FDA published a Safety Communication after receiving 88 reports of acute pancreatitis, including hemorrhagic and necrotizing pancreatitis.
Januvia Pancreatic Cancer
Over time, chronic pancreatitis is a risk-factor for pancreatic cancer, one of the deadliest known cancers. In 2011, researchers from UCLA published a study in Gastroenterology linking Januvia to a 2.7-fold increased risk of pancreatic cancer.
In March 2013, the FDA published a Safety Communication in response to a study linking Januvia and pancreatic cancer. The study, which was published in Diabetes, found evidence of pre-cancerous growths (microadenomas and a neuroendocrine tumor) in patients who took Januvia or Byetta for at least one year.
Januvia and Thyroid Cancer
Experts are concerned about a possible link between Januvia and thyroid cancer because three very similar drugs — Byetta, Bydureon, and Victoza — have all been associated with an increased risk. The FDA has required a Black Box warning about the risk of thyroid cancer on the label for Victoza and Bydureon after “clinically relevant” doses caused thyroid tumors in rodents.
Symptoms of thyroid cancer:
- Lump or nodule on the throat or neck
- Problems speaking, breathing, or swallowing
- Neck and throat pain
- Changes in voice (hoarseness)
- Unexplained cough
- Swollen lymph nodes
Januvia Side Effects
The most common side effects of Januvia include low blood-sugar (hypoglycemia), nausea, vomiting, indigestion, decreased appetite, and weight-loss. In rare cases, Januvia can cause more serious, life-threatening side effects, such as:
- Pancreatic inflammation
- Hemorrhagic pancreatitis
- Necrotizing pancreatitis
- Pancreatic cancer
- Thyroid cancer
- Kidney Failure
- Joint Pain
Studies Link DPP-4 Inhibitors to Bullous Pemphigoid
A study published in Dermatology in 2016 looked at 3 cases of DPP-4 inhibitor use associated with bullous pemphigoid (BP), a rare skin disorder that causes skin rashes and blistering on the legs, arms and abdomen. All 3 patients showed a clear temporal relationship between DPP-4 inhibitor therapy and onset of the condition. One case was due to Tradjenta use, while the other 2 cases were linked to a combination of Galvus / vildagliptin-metformin.
DPP-4 Inhibitors Linked to Severe Joint Pain: FDA Warning
August 28, 2015 – FDA is warning that Januvia and other DPP-4 diabetes drugs 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.
Januvia Lawsuits Centralized in Federal Court
In August 2013, federal judges ordered that Januvia lawsuits involving pancreatic cancer will be centralized in the U.S. District Court for the Southern District of California before Judge Anthony J. Battaglia. Within just a few months, more than 350 lawsuits were transferred into the following litigation:
- In re: Incretin Mimetic Product Liability Litigation
Plaintiffs in the litigation allege that Amylin Pharmaceuticals, Eli Lilly & Co., Merck & Co., and Novo Nordisk have failed to warn about the risk of pancreatic cancer and other side effects from their diabetes drugs, including Januvia, Janumet, Byetta, and Victoza.
Do I have a Januvia Class Action 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 cases in all 50 states.
Free Januvia Class Action Lawsuit Evaluation: Again, if you or a loved one was injured by Januvia, you should contact our law firm immediately. You may be entitled to compensation by filing a Januvia lawsuit, or by joining a Januvia class action lawsuit and we can help.