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Novo Nordisk introduced Victoza (liraglutide) as a treatment for Type 2 diabetes in 2010. The drug assists patients who don’t naturally produce enough incretins, a hormone released into the bloodstream to stimulate insulin after a meal.
To do this, the drug naturally mimics hormone GLP-1 and resists metabolization by DDP-4 enzymes, and in the process, it lowers the body’s glucose levels.
Since its introduction, the drug brought in $670 million for Novo Nordisk from sales in North America and Europe, but studies have revealed using Victoza may cause a patient to develop pancreatitis and pancreatic cancer.
Background
Issues with Victoza started just a few years after its approval. In 2012, Public Citizen filed a petition with the FDA to get the drug off the market. The document stated using Victoza increases a patient’s risk of developing thyroid cancer, pancreatitis, major allergic reactions, and kidney failure, and further cited the FDA’s data indicating a correlation between drug usage and development of medullary thyroid cancer. While the data comes from rats given eight times the standard dosage, the FDA was initially hesitant to approve the drug.
Not long after, the FDA found that for every one patient taking another diabetes medication, seven taking Victoza developed pancreatitis.
Following this, the British Medical Journal published a study linking Victoza usage with pancreatic cancer development; in fact, patients taking the drug have a 3.7 greater chance of developing the condition. In response, the FDA issued a safety warning telling patients that Victoza and other incretin mimetics may be lead to the development of pancreatitis and pre-cancerous cellular changes, also known as pancreatic duct metaplasia.
Yet, the FDA didn’t require the manufacturer to update its safety warning. Instead, the organization announced plans to review its data to investigate the risk of pancreatic toxicity, but results have yet to be produced.
A year later, data revealed Victoza and other drugs in its class, including Byetta, Bydureon, and Januvia, lead to 319 deaths and 2,827 hospitalizations between 2004 and 2014.
However, as patients taking Victoza may also develop gastrointestinal issues, abdominal pain may initially mask the symptoms of pancreatitis, resulting in a delayed diagnosis and treatment.
Lawsuits
While other drugs in the class have been the subject of large-scale lawsuits, Victoza only started receiving attention recently.
Currently, plaintiffs’ cases have been consolidated into multi-district litigation (MDL) in the U.S. District Court for the Southern District of California. 300-plus claims are pending, as of 2015.
Did you develop pancreatitis or pancreatic cancer after taking Victoza? Patients in this situation went through lengthy ordeals of diagnosis, expensive treatment, and time off from work, and the drug manufacturer must be held accountable.
