What’s the Problem?
Lawsuits have been filed against Novo Nordisk alleging that Victoza caused pancreatic cancer, thyroid cancer, and kidney failure. Affected patients and their loved ones may be eligible to seek compensation through the filing of a lawsuit.
What is Victoza?
The Victoza pen (generic: liraglutide) is an injectable diabetes medication that works by mimicking incretin hormones the body produces naturally to stimulate the release of insulin in response to a meal. The drug is intended to be used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes. Victoza is made by Novo Nordisk, and was approved by the U.S. Food & Drug Administration (FDA) in January 2010.
FDA’s approval of Victoza came against the advice of two reviewing pharmacologists and a clinical safety review. In her statement against the approval of Victoza, clinical safety reviewer Dr. Karen Mahoney said:
“The clinical safety reviewer does not recommend approval of liraglutide at this time … In the United States, there are already 11 classes of drugs approved for glycemic control in type 2 diabetes … The need for new therapies for type 2 diabetes is not so urgent that one must tolerate a significant degree of uncertainty regarding serious risk concerns.”
Which Other Drugs are Incretin Mimetics?
In addition to Victoza, other type 2 diabetes medications in the incretin mimetic class include:
- Exenatide (Byetta, Bydureon)
- Sitagliptin (Januvia, Janumet, Janumet XR, Juvisync)
- Saxagliptin (Onglyza, Kombiglyze XR)
- Alogliptin (Nesina, Kazano, Oseni)
- Linagliptin (Tradjenta, Jentadueto)
Victoza and Pancreatic Cancer
Some patients who took Victoza and other incretin mimetic diabetes drugs have developed pancreatitis and pancreatic cancer. The following studies have linked the medications to an increased risk for these diseases:
- March 2013 – Study published in the journal Diabetes found that patients treated with incretin mimetics were more likely to have increased pancreatic mass and precancerous cells, which may eventually evolve into tumors or pancreatic cancer.
- June 2016 – New England Journal of Medicine (NEJM) study designed to assess the cardiovascular safety of Victoza found an increased risk of pancreatic cancer in patients treated with the drug. Specifically, pancreatic cancer occurred in 13 Victoza users compared to 5 patients treated with placebo.
How Can Victoza Cause Pancreatic Cancer?
Patients with type 2 diabetes typically do not have enough naturally-occurring Glucagon-Like Peptide-1 (GLP-1) incretins. Because GLP-1 is quickly metabolized by an enzyme called Dipeptidyl-Peptidase-4 (DPP-4), it is believed that injecting naturally-occurring GLP-1 is not an effective long-term treatment for diabetes patients.
Victoza and other incretin mimetics mimic naturally-occurring GLP-1 hormones, but are resistant to metabolization by DPP-4 enzymes. As a result, the medications lower blood glucose levels by increasing GLP-1 receptor activity; however, this mechanism of action may increase levels of GLP-1, putting patients at risk for developing pancreatic cancer.
Pancreatic Cancer Symptoms
Signs and symptoms of pancreatic cancer often don’t occur until the disease is in its advanced stages. However, when they do appear, symptoms may include:
- Upper abdominal pain that may radiate to the back
- Yellowing of the skin and whites of the eyes (jaundice)
- Loss of appetite
- Weight loss
- Blood clots
FDA Warning on Victoza
In March 2013, the FDA issued a Drug Safety Communication stating that it would be evaluating new studies that suggest an increased risk of pancreatitis and pre-cancerous cell changes (pancreatic duct metaplasia) associated with incretin mimetic diabetes drugs like Victoza.
Victoza and Thyroid Cancer
Before Victoza was approved by the FDA, Novo Nordisk was required to conduct safety studies of the drug on laboratory rats. Results of the tests indicated that Victoza caused malignant tumors of the thyroid gland. The results were most significant at high doses, but an increased risk of thyroid cancer was also seen at normal exposures.
In response to the studies, FDA required Novo Nordisk to send a letter to doctors specifically warning about the risk of thyroid cancer associated with Victoza. The company is also required to keep track of all thyroid cancer cases in Victoza users over the next 15 years.
In human studies, the risk of thyroid cancer was higher for patients taking Victoza than patients treated with other type 2 diabetes medications:
- Papillary Thyroid Cancer was 3x more common in Victoza patients;
- Thyroid C-cell hyperplasia (proliferation of C-cells in the thyroid) was 2.4x more common in Victoza patients.
Due to a growing number of post-marketing reports linking Victoza to severe kidney damage, FDA has required the manufacturer to include a warning on the drug’s labeling which states:
“Victoza may cause nausea, vomiting, or diarrhea leading to dehydration, which may cause kidney failure. This can happen in people who have never had kidney problems before.”
Victoza Side Effects
- Pancreatic cancer
- Thyroid cancer
- Kidney failure
- Life-threatening allergic reactions
May 2008 – Filing for approval
May 30, 2008 – Novo Nordisk files for Regulatory Approval of liraglutide in the U.S. and Europe.
Apr 2009 – FDA Advisory Committee meeting update
April 3, 2009 – Update on FDA Advisory Committee Meeting on liraglutide for the treatment of type 2 diabetes.
Jan 2010 – Approved by the FDA
January 25, 2010 – Victoza first approved by the FDA.
Apr 2012 – Victoza label updated
April 9, 2012 – Victoza label updated to include data showing superior efficacy compared to Januvia.
Mar 2013 – FDA announces investigation
March 14, 2013 – FDA announces that it is investigating the risk of pancreatitis, pancreatic cancer with Victoza and other incretin mimetic diabetes drugs.
Jun 2016 – New England Journal of Medicine study published
June 13, 2016 – Study published in the New England Journal of Medicine (NEJM) finds increased risk of pancreatic cancer with Victoza.
- “Marked Expansion of Exocrine and Endocrine Pancreas with Incretin Therapy in Humans with increased Exocrine Pancreas Dysplasia and the potential for Glucagon-producing Neuroendocrine Tumors”. American Diabetes Association (ADA). March 2013.
- “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.
- ”Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes”. New England Journal Of Medicine (NEJM). June 13, 2016.