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.
What is the Problem with Victoza?
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
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.
Is Victoza Safe or is Victoza Dangerous?
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.
What are the Dangers of Victoza?
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.
What are Victoza Side Effects?
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.
Is Victoza Linked to Pancreatic Cancer?
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.
Is Victoza Linked to Thyroid 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.
Did Victoza Have a Failure to Warn?
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.
Has There Been a Victoza Recall?
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.
Do I Have a Victoza Case and What Do I Do to File?
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.
How Likely is a Victoza Settlement?
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.
What are my Victoza Damages?
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!