Made by Novo Nordisk, Victoza is the generic drug liraglutide and is used to treat the high blood sugar levels associated with type 2 diabetes. This chronic condition can often be reversed with good lifestyle changes, but most patients want or need a quicker fix and drug companies have rushed to fill the market with a solution.
Victoza has been on the market since 2010 when it was approved by the U.S. Food and Drug Administration. Although it may be an important way for some people to control blood sugar, the last few years have led to the realization that this drug causes some serious side effects. In addition to the most common side effects, there is also evidence that Victoza can cause a dangerous type of pancreatitis and even pancreatic cancer and thyroid cancer. These rare but devastating side effects have triggered a number of lawsuits against Novo Nordisk.
What is Victoza?
Victoza is liraglutide and it was developed by Novo Nordisk to help people with type 2 diabetes. The FDA approved it for this purpose in 2010, but like other drugs for type 2 diabetes, patients are supposed to combine it with lifestyle changes. These include things like losing weight, eating a healthier diet, quitting smoking, and getting more exercise. Although liraglutide is indicated for controlling blood sugar, it is not supposed to be used in people with type 1 diabetes or a condition called diabetic ketoacidosis.
How it Works
Type 2 diabetes is a condition in which a person has lost sensitivity to the hormone insulin and may also produce less of it than is normal. As a result, this person has chronically high blood sugar levels. Insulin is the hormone produced by the pancreas that in healthy people keeps blood sugar levels normal and stable. Not treating type 2 diabetes can lead to serious, lifelong complications, and ultimately to death.
Liraglutide is a type of type 2 diabetes drug called an incretin mimetic. These are drugs that mimic hormones related to insulin. Liraglutide mimics glucagon-like peptide-1, or GLP-1. This hormone plays a role in moving food through the digestive tract and triggering the production of insulin after eating so that it can control rising blood sugar from that meal. As a GLP-1 mimic, Victoza can stimulate these things and keep blood sugar levels down.
Most Common Victoza Side Effects
The side effects that are possible with Victoza are largely well-tolerated by patients and mostly not worrisome. However, some patients may experience some of the more serious and rare side effects that have only been brought to the public’s attention in recent years, things like cancer and pancreatitis. Fortunately most patients won’t experience these.
The most common and less serious Victoza side effects are cold and flu symptoms like congestion and achiness, fatigue, heartburn, constipation, and difficulty urinating. Victoza is an injectable drug, so a rash, irritation, or infection at the injection site is also a possible side effect. In rare cases someone may have a severe allergic reaction to the drug, which needs to be treated as an emergency. Signs of this reaction include swelling in the face and throat, trouble breathing, and hives or a rash.
Pancreatitis
One of the more serious side effects of Victoza is pancreatitis. This is the swelling or inflammation of the pancreas. Most worrying is that the drug can cause a dangerous form of this condition called acute pancreatitis. All incretin mimetics have the potential to cause it, a sudden onset of pancreatitis. It starts as a pain in the abdomen that may radiate to the lower back. There may be tenderness when the abdomen is touched along with nausea and vomiting.
Most importantly, acute pancreatitis rapidly gets worse with time. It does not get better without treatment and it can quickly go from moderate pain to severe pain and a potentially fatal situation. Anyone taking Victoza needs to know the signs of pancreatitis and be prepared to seek emergency treatment if necessary.
The FDA issued a warning about pancreatitis in 2011, citing research that found Victoza caused more incidences of pancreatitis than most other kinds of type 2 diabetes drugs. Within the first several months that the drug was on the market in 2010, the FDA received nearly 100 reports of adverse events related to pancreatitis. In one study of patients taking Victoza, one died of pancreatitis.
Pancreatic Cancer
It may also be possible that Victoza could trigger pancreatic cancer as another terrible side effect. The evidence that this may happen is minimal and more research is needed, but there is proof that a connection is likely. It comes from a study in which researchers looked at the pancreas tissue from deceased patients. Those who had taken certain type 2 diabetes drugs, including Victoza, showed signs of having pre-cancerous pancreatic cells developing at the time of death. The FDA does not consider this sufficient evidence to issue a warning or to change the label on Victoza, but investigations are ongoing.
Thyroid Cancer
Another potential side effect, but one that also needs more investigation, is thyroid cancer. During trials with laboratory animals, Novo Nordisk found that Victoza triggered the formation of malignant tumors in the thyroids of rats. Thyroid cancer is very rare in people, so whether or not Victoza will really cause it to form in humans is not yet understood.
However, since it was seen in rats, the FDA did announce that thyroid cancer is a risk with Victoza. It also required that Novo Nordisk add a black box warning about it to the label for the medication. People with a history or risk factors for thyroid cancer should not use Victoza.
Lawsuits over Side Effects
The side effects of all incretin mimetics are similar and include pancreatitis, pancreatic cancer, and thyroid cancer. Companies that make the medications Byetta and Januvia have already faced lawsuits over these issues and it is expected that Novo Nordisk will soon see suits because of Victoza. Some people want to see all incretin mimetics consolidated into one large multidistrict litigation case because they are so similar and have caused the same problems in patients.
These patients and their loved ones feel that the drug companies did not meet their responsibilities in either properly testing their products to find out what the risks are or warning patients of those risks. If you find yourself in a similar situation, you may want to join forces with other patients and victims or start your own lawsuit against Novo Nordisk. A lawyer can help you decide if this is an option and how strong your case would be.
Sources
- https://www.nlm.nih.gov/medlineplus/druginfo/meds/a611003.html
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf
- http://www.fda.gov/Drugs/DrugSafety/ucm343187.htm
- http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258826.htm
- http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm198543.htm
- http://www.ncbi.nlm.nih.gov/pubmed/23136352