Recent studies have determined that Victoza, an FDA-approved type 2 diabetes medication, has the potential to cause thyroid cancer. This rare disease occurs when abnormal cells multiply and form tumors within the thyroid, a gland in the neck that controls how the body uses energy, makes proteins, and controls how sensitive the body is to other hormones. This article discusses theories on how scientists believe Victoza causes thyroid cancer, and the petition to recall the drug submitted by Public Citizen.
How Can Victoza Cause Thyroid Cancer?
Victoza was a controversial drug even before it was approved by the U.S. Food & Drug Administration (FDA). In clearing the drug, the FDA chose to ignore the recommendations of three of its drug safety reviewers. In clinical trials, high doses of Victoza were found to cause thyroid tumors in rats and mice, although the administration said at the time that it was not known if Victoza had the potential to cause thyroid cancer in humans. The clinical safety reviewer noted that at the time of approval, there were already nearly a dozen different medications for type 2 diabetes on the market, so there was little need to approve another drug whose safety profile was questionable.
Despite these serious concerns, FDA’s director of new drugs overruled all other considerations, including the clinical safety reviewers, in clearing Victoza for sale on the U.S. market. However, the FDA did ask drugmaker Novo Nordisk to conduct a five-year study to look at Victoza’s association with thyroid cancer, pancreatic cancer, pancreatitis, low blood sugar levels, and allergic reactions.
FDA Warning on Victoza
In June 2011, the FDA issued a warning regarding Victoza’s link to thyroid cancer. According to the warning, the administration had received at least two dozen reports of thyroid cancer in Victoza users in the previous year. The thyroid gland is located at the base of the neck, just below the Adam’s apple. It manufactures hormones that regulate heart rate, blood pressure, body temperature and weight. Signs and symptoms of Victoza thyroid cancer include:
- A lump in the neck
- Trouble breathing
- Trouble swallowing
Victoza Recall Petition
In April 2012, the watchdog group Public Citizen petitioned the FDA for a nationwide recall for Victoza, claiming that the medication’s risks outweigh any potential benefits. According to the petition, Victoza puts users at risk of developing thyroid cancer, pancreatitis, allergic reactions, and kidney failure.
“More and more people are taking this drug, and more people are experiencing serious health problems as a result,” Public Citizen director Sidney Wolfe, MD, said in a statement. “Clearly, the FDA’s warning system is not sufficient. The drug should be taken off the market.” Click here to read more about Public Citizen’s petition to recall Victoza from WebMD.