Public Citizen, a prominent consumer watchdog group, has petitioned the U.S. Food and Drug Administration (FDA) to not expand the diabetes drug Victoza to be used for weight loss purposes, telling the FDA that Victoza is “too toxic to be approved for weight loss at a higher dose than that approved for diabetes.” Public Citizen claims the drug puts patients at higher risk of thyroid cancer, pancreatitis and other problems.

According to Public Citizen, within 17 months of Victoza’s approval, there were more than 200 cases of pancreatitis among Victoza users, and the FDA was required to go back and add warnings for pancreatitis, thyroid cancer, and kidney failure.

Victoza is a once-a-day drug manufactured by Novo Nordisk. The FDA approved it in January 2010. Victoza is similar to Amylin Pharmaceuticals’ injectable diabetes drug Byetta (exenatide) in that it aims to lower blood sugar by mimicking a hormone called GLP-1. As of March 2013, almost 1 million Americans took Victoza or another GLP-1 mimetic.

Victoza is currently available as a diabetes drug, containing the active pharmaceutical ingredient liraglutide. Novo Nordisk is proposing a new higher-dose version of the drug, which would be marketed as Saxenda, seeking approval to market the medication as a weight-loss aid.

Though it is effective in controlling blood sugar, Victoza may be linked to dangerous side effects, including pancreatitis and pancreatic cancer.

FDA Warns of Potential Health Risks

The FDA issued a Drug Safety Communication, alerting the public to a study that suggested Victoza and other type-2 diabetes medications were linked to an increased risk of pancreatitis and pre-cancerous cellular changes, called pancreatic duct metaplasia. These risks were reportedly found in a group of drugs known as incretin mimetics, which includes Byetta, Bydureon, Victoza, Januvia and other medications.

According to an FDA safety alert posted in June 2011, Novo Nordisk reported more patients suffered from pancreatitis while taking Victoza in clinical trials than patients treated with comparable drugs. Researchers studied a small sampling of pancreatic tissue samples from patients who died of unspecified causes and were treated with an incretin mimetic. The data showed pre-cancerous cells in the pancreas.

The Institute for Safe Medication Practices (ISMP) reported that the FDA’s clinical safety reviewer originally voted against approving Victoza because of its link to pancreatic cancer as well as an increased risk for pancreatitis.

How is Victoza Linked to Pancreatic Cancer?

Victoza works by stimulating natural insulin production in the pancreas. Victoza may be prescribed alongside oral diabetes medications such as Actos, Avandia, Amaryl (glimepiride) and metformin, but may impact the absorption of these drugs since it delays gastric emptying.

In doing so, Victoza increases the patient’s GLP-1 receptor activity. It has been theorized, however, that this increased activity may put the user at a greater risk of developing pancreatic cancer.

While Victoza’s link to pancreatic cancer has yet to be proven, medical experts hypothesize that these conditions could result due to how the patients metabolizes the drug. Victoza is a GLP-1 agonist. This and other drugs in this family work by encouraging the body’s incretin manufacturing process, which helps maintain a healthy level of insulin.

Victoza Lawsuits

The makers of Byetta and Januvia are facing numerous Victoza lawsuits that claim the drugs caused pancreatitis and pancreatic cancer. Because Victoza is in the same class of drugs, similar lawsuits against Novo Nordisk are expected to follow. Novo Nordisk is proposing a new higher-dose version of the drug, which would be marketed as Saxenda, seeking approval to market the medication as a weight-loss aid.

Patients injured by Victoza are likely to claim that they were not warned of the serious Victozaside effects. There is a petition to have all incretin mimetic lawsuits consolidated into a single federal multidistrict litigation (MDL).