What is Victoza?

Victoza (liraglutide) was approved by the FDA in 2010 as a new drug to treat type-2 diabetes. Like some other drugs used in the treatment of type-2 diabetes, Victoza works by mimicking a naturally-occurring hormone in the body known as GLP-1 (glucagon-like peptide 1). GLP-1 stimulates the pancreas, causing it to release insulin into the bloodstream and triggering cells to absorb sugar from the bloodstream. Victoza, manufactured by Novo Nordisk is known as an incretin mimetic—it mimics the actions of incretin hormones in the body, increasing insulin production in response to meals and decreasing the production of glucose from the liver.

Victoza has also been found to slow the emptying of food from the stomach, thereby decreasing the amount of food eaten and causing weight loss in a significant number of patients. Victoza comes in a pre-filled, multi-dose pen and is injected once daily unlike some similar drugs which are injected before breakfast and before dinner. Victoza is not insulin, and when used in combination with insulin, metformin (Glucophage), pioglitazone (Actos), or rosiglitazone (Avandia) can increase the risk of low blood sugar or hypoglycemia.

Drugs like Victoza which mimic GLP-1 have been found to cause sudden inflammation in the pancreas among some patients. This inflammation can, in turn, lead to acute pancreatitis which is a risk factor for developing pancreatic cancer. A study published in the journal Diabetes in May, 2012, found that Victoza may stimulate the production of precancerous cells. The theory is that those who have developed abnormalities of the pancreas (such as the precancerous cells) are then more likely to develop pancreatic cancer.

Public Citizen, a consumer advocacy group, found 28 reports of pancreatic cancer among those taking Victoza—as opposed to only one case of pancreatic cancer among the other group taking a diabetic drug which did not mimic GLP-1. While it would appear that these reports—later submitted to the FDA database—indicate Victoza may increase the risk of pancreatic cancer, without adequately controlled studies, there is no way to know for sure. The manufacturer of Victoza is conducting a 9,000 patient study regarding the safety of the drug as required by the FDA, however this study may not be large enough to determine the actual risk of pancreatic cancer from Victoza.

Even though a Washington D.C. advocacy group asked the FDA for an immediate ban of Victoza—citing such safety concerns as an increased risk of thyroid cancer, acute pancreatitis, kidney failure and allergic reactions—the manufacture of Victoza has rejected arguments demanding a recall of one of their top-selling drugs. Novo Nordisk indicated they expect no action from the FDA regarding the Public Citizen’s petition and stated physicians and consumers should be confident in the safety of Victoza. Even though Victoza has been on the market less than three years, it is one of Novo Nordisk’s best selling drugs with sales over $350 million dollars per quarter.

Animal studies regarding Victoza showed a higher rate of thyroid tumors, many of which were cancerous. Among human patients, the small number of studies showed that the risk of pancreatitis was greater among patients taking Victoza than those taking other diabetes drugs. This higher risk of pancreatitis also leads to an increased risk of pancreatic cancer which is one of the more deadly forms of cancer. When the FDA approved Victoza they asked that the manufacturer conduct an additional study to test Victoza safety among those patients with a high risk of heart problems. The FDA further required Novo Nordisk to establish a cancer registry to monitor the rate of thyroid cancer for the next fifteen years and to conduct a five-year study which will test the risk of thyroid and pancreatic cancers as well as allergic reactions among Victoza users.

Should you experience any sign of allergic reaction (hives, difficulty breathing, swelling of lips, tongue, face or throat) when taking Victoza you are likely having a severe allergic reaction and should seek emergency medical help immediately. Other serious side effects include any sign of infection such as fever, chills, sore throat or flu-like symptoms, bruising or bleeding more easily than normal, a swelling or lump in the throat area, shortness of breath, difficulty swallowing, hoarseness when speaking and symptoms of pancreatitis—severe pain in the upper stomach which spreads to the back, vomiting or nausea, increased heart rate or appetite loss. There are less serious side effects which may or may not decrease with time. These side effects include: dizziness, headache, nausea or upset stomach, diarrhea or constipation, symptoms of a cold, back pain, fatigue, a mild skin rash or redness at the injection site.

An article in the November 2012 issue of The Annals of Pharmacotherapy reviewed the evidence surrounding an association between Victoza and pancreatitis. One study detailed eleven cases of pancreatitis among those taking Victoza, nine of which were classified as acute pancreatitis while the remaining two were classified as chronic pancreatitis. One of the eleven patients died from acute pancreatitis. There is some controversy, however, over whether the underlying medical condition (diabetes) is responsible for causing pancreatitis or whether the diabetes drug—which has been shown to cause inflammation in the pancreas—is responsible.

High Wire, a Stanford University publication, printed an article regarding liraglutide-associated acute pancreatitis in 2012. One specific case highlighted a 53-year old man with type-2 diabetes who arrived at the emergency room with symptoms of acute pancreatitis. Two months prior his dosage of Victoza had been increased from 0.6 to 1.2 mg daily. After ruling out elevated triglycerides the diagnosis of acute pancreatitis was made and Victoza discontinued. All symptoms ceased within eight days; the patient was released and prescribed a different type of diabetes drug. Ehealthme.com reported on April 15, 2013 that 11,308 people reported significant side effects while taking Victoza, with 83 of those developing pancreatic cancer.

Lawyers and Settlement reported that on April 19, 2012, Public Citizen cited the risk of thyroid cancer as well as pancreatitis and pancreatic cancer stemming from Victoza. When Victoza was approved in 2010, the FDA noted animal data suggested a rare type of thyroid cancer—medullary thyroid cancer—was linked to the use of Victoza. Studies in mice indicated Victoza was linked to thyroid gland tumors, particularly at higher dosages. Even though the FDA concluded Victoza could increase the risk of thyroid cancer, the drug was approved due to the fact researchers were statistically unable to show significant risk to humans. During clinical trials, four patients developed thyroid cancer, however rather than ban the drug the FDA chose to require Novo Nordisk to include a black box warning label cautioning those with a family history of thyroid cancer not to take Victoza.

It is likely that ensuing lawsuits against Novo Nordisk will allege a failure to warn. In fact, one Louisiana woman filed a lawsuit against the manufacturers of Victoza, as well as the manufacturers of Janumet and Byetta on March 20, 2013. Rosalie Duhon filed her complaint in the U.S. District Court for the Southern District of California, claiming she developed pancreatic cancer as a result of these type-2 diabetic drugs. Earlier in March the FDA announced they were investigating a potential link between pancreatic cancer and incretin mimetics—the class of drugs Victoza belongs to. Duhon’s claim states that had she been properly warned regarding the increased risk of developing pancreatic cancer from Victoza, Byetta and Janumet she would not have taken the drugs. In addition to failure to warn, the manufacturers are accused of designing defective drugs, breach of warranty, fraudulent concealment, negligence and negligent misrepresentation.

Even though advocacy groups have called for a recall of Victoza, the drug has not been recalled as the manufacturer continues to assert its safety to consumers. It is believed by many that a recall of Victoza is almost inevitable—the only question is when the recall will take place, and how many people will suffer significant harm prior to that recall.

Any consumer who has been diagnosed with type-2 diabetes and prescribed Victoza then suffered serious side effects may have a case against Novo Nordisk. After seeking medical help, it is important to consult an attorney regarding the damages you have suffered from taking Victoza. The attorneys of Sullo & Sullo are highly experienced in product liability cases and can discuss your case with you to determine whether a lawsuit is appropriate for your specific circumstances. Our attorneys will be personally involved in your case and will go the extra mile to protect your rights. Most states—including Texas—have a two year statute of limitations although some other states may have a one, three, four or five year statute, so be sure to mention to your Sullo & Sullo Victoza Attorney where you reside.

The likelihood of a Victoza settlement may depend in part on whether a recall is issued and how many lawsuits are eventually filed against the manufacturer. Whether a Victoza class action suit will be filed remains to be seen. If the progression of the Victoza lawsuits follow that of Januvia and Byetta, we will likely see some cases combined in MDL’s or mass torts. Our Sullo & Sullo attorneys believe that drug companies should pay when they are proven to have been irresponsible and unconcerned about the safety of consumers. We offer aggressive representation, compassion for your situation and will always be concerned about your future.

The specific Victoza damages will, of course, depend on the severity of the harm you have suffered as a result of taking Victoza. Our attorneys will never suggest you file a lawsuit unless they feel it is in your best interests to do so. Should our Sullo & Sullo attorneys believe you have a solid Victoza case, they will work zealously to recover medical expenses, lost wages and pain and suffering for you. We have the necessary experience and knowledge to help you through this difficult time—call Sullo & Sullo today!