Victoza, a drug used in the treatment of Type 2 diabetes which received FDA approval in 2010, has suffered serious Victoza safety concerns as more patients are reporting adverse health issues after taking the drug. The advocacy group, Public Citizen, filed a petition with the FDA in April of 2012, requesting that Victoza be removed from the market. The group cited higher-than-normal risks of thyroid cancer, pancreatitis, severe allergic reactions, kidney failure and pancreatic cancer, stating these risks far outweighed the benefits of the drug.
Further, two FDA pharmacologists and one FDA clinical safety reviewer advised the FDA not to approve the drug until further studies had been conducted—when Victoza was approved, these three released the statement that “The approval was a huge blow to the health and safety of diabetics in this country.” This was largely due to animal studies done on the drug which suggested a rare type of thyroid cancer (medullary thyroid cancer) was significantly linked to Victoza, known by the generic name of liraglutide. As a result of these potential safety risks, the manufacturer of Victoza, Novo Nordisk, was asked by the FDA to provide a Risk Evaluation and Mitigation Strategy as well as to begin a five-year epidemiological study of Victoza dangers.
Victoza Safety Concerns—Risk of Thyroid C-Cell Tumors
Although the safety studies on laboratory rats and mice did show an increase in medullary thyroid carcinoma, the human risk of the disease has not been definitively proven although it cannot be ruled out. For this reason Victoza is contraindicated in those patients who have a family history or a personal history of this type of thyroid cancer or in patients where Multiple Endocrine Neoplasia Syndrome Type 2 could not be ruled out.
Victoza Pancreatitis
The Public Citizen press release noted the following risks of pancreatitis and pancreatic cancer among users of Victoza: Pancreatitis was increased nearly four times the normal risk in Victoza patients as opposed to those taking a different drug to control their Type 2 diabetes. Within the first seventeen months following FDA approval of Victoza, over 200 patients were diagnosed with acute pancreatitis. Some research states that only about 10% of adverse health reactions are ever reported, meaning there are potentially many more patients who have suffered Victoza pancreatitis. In 2011, only a year after Victoza received FDA approval, the FDA required Novo Nordisk to place a black box label on the drug’s packaging which warns consumers of the risks of pancreatitis and thyroid cancer.
Victoza Pancreatic Cancer
Because repeated bouts of pancreatitis have been linked to pancreatic cancer, this is a concern for those taking Victoza as well. Unfortunately, pancreatic cancer is one of the most serious types of cancer with a low rate of survival. One study placed the risks of developing pancreatitis with the injectable form of Victoza at 28.5 times higher than that of the older diabetic medications. Victoza was also found to be associated with hypersensitivity over eight times that of older medications. In 2011, a study published in Gastroenterology found that patients taking drugs similar to Victoza had nearly three times the risk of pancreatic cancer. One of the authors of the study, Dr. Peter Butler, has advocated for more research regarding Victoza pancreatic cancer.