Despite the fact that a consumer watchdog group—Public Citizen—has demanded that Victoza be removed from the market, the type-2 diabetes drug is still being sold. Although the drug has only been on the market since FDA approval in 2010, more consumers are coming forward claiming they have suffered serious side effects from Victoza including pancreatitis, thyroid cancer and pancreatic cancer. The Public Citizen group claims the relatively new type-2 diabetes medicine subjects patients to undue risk for not only the serious diseases listed above, but serious allergic reactions and kidney failure as well. Victoza is a once-a-day injection drug which mimics the GLP-1 hormone in the body. This hormone triggers insulin production whenever blood sugar levels have risen to a dangerous level. Victoza is not considered a “first choice” diabetes medication, rather is a drug prescribed by doctors when other drugs have proven ineffective.

The director of Public Citizen, Sidney Wolfe, MD, stated that the FDA’s current approval methods and systems in place for warning consumers is simply insufficient and the drug should be recalled. The manufacturer of Victoza, Novo Nordisk “strongly disputes” this statement as well as the Public Citizen’s allegations that Victoza causes harm to those taking the drug. While the label of Victoza warns patients that thyroid tumors and cancers have been found in laboratory rats during animal studies of Victoza, it goes on to say that it is not yet known if humans are at the same risk. The Victoza label warns patients with a genetic history of pancreatic cancer, thyroid cancer or kidney problems to avoid Victoza and to seek medical attention if any suspicious lumps or other symptoms arise after starting Victoza.

Perhaps the most alarming potential side effect of Victoza is the development of pancreatitis—acute or chronic—which can turn into pancreatic cancer. Pancreatic cancer is considered one of the more deadly forms of cancer, with a very low five-year survival rate and because the early symptoms may not be as clear as those of some other forms of cancer, pancreatic cancer is rarely caught early enough to be easily treatable. Public Citizen claims those taking Victoza are four times as likely to be diagnosed with acute pancreatitis as patients taking other diabetes drugs, stating over 200 patients have reported acute pancreatitis attacks since the 2010 approval of the drug.

The group further states that since only 10% of adverse symptoms are generally reported, there could be as many as 2,000 actual patients who have suffered serious outcomes related to Victoza. A study created by eHealthMe, based on 83 FDA reports, detailed pancreatic cancer trends among Victoza patients. 11,308 Victoza users were studied showing 83 of those developed pancreatic cancer. Of those 83, 60% were male, and 40% female. The incidence of pancreatic cancer showed up within one month among 27.12% of the patients, within 1-6 months among 33.90 % of the patients, within 6-12 months among 25.42% of the patients, within 1-2 years among 11.86% and within 2-5 years for the remaining 1.69%. These statistics seem to show that among those who developed pancreatic cancer while taking Victoza, the disease occurred fairly quickly from the time they first began taking the drug. Over 40% of the 83 patients who developed pancreatic cancer were also taking the diabetes drug, Metformin.

Although there are some early warning signs of pancreatic cancer, many of them can be related to other diseases as well and are often ignored. Diabetes which comes on suddenly may be related to a pancreatic tumor already beginning. Jaundice can be an early warning sign of pancreatic symptoms as well as itchy skin on the palms and soles of feet, a lack of appetite which leads to unexplained weight loss, changes in taste, a gnawing abdominal pain which radiates toward the back which may lessen when the patient leans forward, an enlarged gallbladder or stools which are dark and tarry or pale and foul-smelling. Victoza may cause inflammation in the pancreas which can, in turn, cause abnormal cells to develop, eventually leading to cancerous pancreatic tumors.

Relatively mild symptoms reported by patients taking Victoza include redness and rash at the site of injection, mild skin rashes, fatigue, back pain, symptoms of a cold, diarrhea, constipation, nausea, vomiting, upset stomach, loss of appetite, dizziness and headache. In a 52-week monotherapy study, the most reported adverse symptom from taking Victoza was nausea. More serious symptoms related to Victoza which required a physician’s assistance included a lump or swelling in the throat area, shortness of breath, a hoarse voice, swallowing difficulties, pancreatitis symptoms of pain in the upper stomach spreading to the back, increased heart rate, appetite loss, nausea and vomiting. Flu-like symptoms from Victoza including infection, fever, chills, sore throat, mouth sores, weakness and bruising or bleeding also require the patient to seek medical attention.

While not as well-documented, there is some indication that of the thyroid cancer causes, Victoza could be a contributor. Novo Nordisk, Victoza’s manufacturer, warns in their labeling information for Victoza that based on research and studies done on laboratory animals, Victoza could be responsible for a higher-than-normal rate of thyroid cancers and tumors. The rats and mice were given dosages of Victoza comparable to those humans would take, meaning Victoza could possibly cause thyroid cancer in humans. Pre-approval research done on human patients showed Victoza carried a greater risk of papillary thyroid cancer—three times higher—and a 2.4 times higher risk of thyroid C-cell hyperplasia. This abnormally high risk caused the FDA to require Novo Nordisk to conduct a 5-year study to assess the rates of thyroid cancers between those taking Victoza and those who were taking another diabetes drug.

It is believed Victoza causes inflammation in the pancreas which in turn leads to pancreatitis, pancreatic tumors and pancreatic cancer. A little over a month ago the FDA issued a Drug Safety Communication regarding Victoza pancreatitis which investigated the numerous reports of the potential increased risk of pancreatitis, pancreatic cancer and thyroid cancer. The FDA stated in this latest safety communication that they had not previously warned physicians and Victoza patients about the potential risk of “pre-cancerous findings of the pancreas with incretin mimetics.”

The attorneys at our law firm have worked for many years to help those harmed by unsafe drugs or medical devices. We value our clients and never treat them as simply another “case.” We are aggressive in our goal of protecting the rights of our clients and fighting to get them what they deserve after having been harmed by a drug which they believed to be safe. We take our job seriously, offering compassion to our clients while using every resource available to recover medical expenses, lost wages and pain and suffering. When it is found that a drug was not sufficiently tested and may even have been marketed by a manufacturer who had little regard for the health of the consumers, our Sullo & Sullo attorneys will work zealously for our clients. Don’t face an uncertain future on your own; call our offices to receive a comprehensive evaluation of your case.