Monday, July 29, 2013

Do You Need Victoza Legal Representation?

Victoza is one of several newer drugs used in the treatment of Type 2 diabetes which have come under fire due to a potential of an increased risk of pancreatitis, pancreatic cancer, thyroid cancer, allergic reactions and kidney problems. Although Victoza gained FDA approval in 2010, three members of the FDA panel spoke out against that approval. Studies done on laboratory animals prior to the approval showed that a rare type of thyroid cancer occurred at significantly higher rates among lab animals given Victoza. Novo Nordisk, the manufacturer of the drug, discounted those studies, claiming the same issue was not seen among human subjects. Studies and research done since that time appear to disprove that claim. Some studies place the risk of pancreatitis among Victoza users from four to six times that of a person taking an older diabetic drug.

Once patients have experienced repeated bouts of pancreatitis, the risks of developing pancreatic cancer increase substantially. One group known as Public Citizen has demanded a recall of Victoza due to the inherent dangers associated with the drug however as of this date no recall is expected.

May You  Be Entitled to a Victoza Settlement?
The question of whether or not you may be entitled to a Victoza settlement depends, of course, on the level of harm you suffered after taking the drug. If you developed a serious or potentially fatal illness such as pancreatic cancer after taking Victoza you may be entitled to compensation. You deserve to have your medical expenses paid for as well as being compensated for lost wages and pain and suffering. Your potential Victoza damages would depend on the facts surrounding your case. If you are like many Victoza patients, neither you nor your doctor was aware of the potential harm you could suffer from taking Victoza.

Making Sure You Meet the Victoza Statute of Limitations

The Victoza statute of limitations varies considerably from state to state. Texas, as with the majority of states, operates under a two-year statute while some other states have statutes as short as one year or as long as three, four, five or six years. Should a statute be missed, it can be very difficult, if not impossible, to ever receive compensation for your damages.

Friday, July 26, 2013

Should You Consider Victoza Legal Action?

Do I Have a Victoza Lawsuit?
If you are one of the thousands of people who have been harmed by taking the Type 2 diabetes drug, Victoza, you may be wondering about whether you should file a Victoza lawsuit. Victoza was approved in 2010, yet only a few months after gaining approval Victoza patients began notifying the FDA about adverse symptoms experienced after starting the drug. At the time Victoza was being considered for FDA approval two FDA pharmacologists and one FDA clinical safety reviewer believed the drug should not be approved until further safety studies had been conducted.

Although the FDA still approved the drug, the three who opposed the drug released a statement saying “The approval was a huge blow to the health and safety of diabetics in this country.” It stands to reason that if members of the FDA were not completely sold on the safety of Victoza, Novo had some indication there could be negative health effects among those taking the drug, therefore those who have been harmed by the drug may be entitled to recover medical expenses, lost wages and pain and suffering.

If you believe you may have a Victoza lawsuit, it is in your best interests to speak to an experienced Victoza attorney who can assess your case and determine the best way to proceed. Obviously those who have suffered more harm—such as the development of pancreatic cancer—will be entitled to a larger settlement, however until you speak to an attorney you will not have the full picture.

Will There Be Victoza Potential Class Action Suits?
There are currently no Victoza class action suits filed, and before joining in such a class action suit potential plaintiffs should obtain good legal advice. Those who join a class action suit will receive the same amount of settlement—should there be a settlement—as every other member of the class. This means that those who have suffered significantly more harm would still receive the same amount of money as those who have suffered much less harm in the event of a settlement.

What about a Victoza Possible MDL?
An MDL, or multi-district litigation is significantly different from a class action lawsuit in that it takes place in federal court and occurs when the safety of a drug comes into question. Once a significant number of lawsuits have been filed, the plaintiff’s attorney or the manufacturer of the drug can ask for an MDL proceeding to be initiated. Plaintiff in an MDL may apply for compensation based on the individual merits of their case. While the claimants may either accept or reject the award, should they accept it, the manufacturer will be released from further liability.

If there is no settlement in an MDL, all the individual cases which were not resolved will be transferred back to the court they were originally filed in and tried before a jury. Although no MDLs have yet to be filed it is expected there will be both MDLs and individual lawsuits filed in state courts, particularly if a recall is issued for Victoza.

Wednesday, July 24, 2013

Victoza Issues: Thyroid Cancer and Other Problems

Victoza Pancreatic Cancer
New evidence suggests a definitive link between the injectable Type 2 diabetes drug, Victoza, and pancreatic cancer. On March 14th, 2013, in a Drug Safety Communication, the FDA stated samples of pancreatic tissue taken from a number of Victoza patients showed significant levels of inflammation and cellular changes, known to precede pancreatic cancer. These tissue samples were taken from patients taking Victoza who died from “various causes.” Victoza is one of several drugs used to treat Type 2 diabetes which mimic the natural hormones which stimulate insulin production following a meal.

Pancreatitis causes inflammation of the pancreas, and, in some cases, can lead to fatal complications. Because pancreatic cancer is often not detected until it is in the advanced stages, the recovery rates for this type of cancer are extremely low. A study published in the journal Gastroenterology, placed the risks of pancreatic cancer among those taking drugs similar to Victoza at nearly three times the risk of those taking older diabetic drugs. This same study placed the risks of pancreatitis at nearly six times that of those taking an older diabetic drug, and those who suffer repeated bouts of pancreatitis are at a much greater risk of developing pancreatic cancer.

Victoza Thyroid Cancer
Victoza received FDA approval in 2010 yet the agency began receiving adverse health reports from those taking the drug only a few short months after that approval. A group known as Public Citizen filed a petition with the FDA in 2012 against Victoza, citing a high risk of thyroid cancer, severe allergies, renal failure and chronic or severe pancreatitis. The members of Public Citizen asked that Victoza be pulled from the market however the FDA has declined to issue a recall for the drug at this point. At the time Victoza was approved by the FDA, two pharmacologists and one clinical safety reviewer advised against approving the drug pending further studies and stated that “The approval (of Victoza) was a huge blow to the health and safety of diabetics in this country.”

Public Citizen based their request to pull Victoza off the shelves on the results of a study done on laboratory rats and mice linking the drug to medullary thyroid cancer. Although the FDA did approve Victoza they asked the manufacturer, Novo Nordisk, to engage in a five year study regarding Victoza dangers as well as to provide a Risk Evaluation and Mitigation Strategy. While the human risk of thyroid cancer has not been definitively linked to Vitctoza, neither has it been ruled out. Those with a personal or family history of thyroid cancer should not take Victoza until further studies have been conducted.

Victoza Safety Concerns Leading to a Victoza Lawsuit

The FDA did require a black box warning on Victoza packaging in 2011 warning about the risks of thyroid cancer and pancreatitis among Victoza patients. Those who have suffered from adverse health risks after taking Victoza should consult their doctor to ensure their health is protected.

Monday, July 22, 2013

Victoza FDA Warnings

Victoza FDA Stance
Victoza, a drug approved for the treatment of Type 2 diabetes, gained FDA approval in 2010 and was touted as an amazing new injectable diabetic drug which only required once-daily injections and was not dependent upon the food eaten or the level of activity. Over 26 million people in the United States are affected by diabetes therefore the market for diabetic drugs has literally skyrocketed. At the time Victoza was submitted by its manufacturer, Novo Nordisk, for FDA approval, there were two FDA pharmacologists and one FDA clinical safety reviewer who did not believe the drug warranted approval until further safety studies were conducted.

This stance was based in part on animal studies which suggested a link between a rare type of thyroid cancer and Victoza.  When the FDA ignored the three who opposed the drug’s approval they released a statement which read in part, “The approval was a huge blow to the health and safety of diabetics in this country.” While the FDA panel approved Victoza they added a caveat that the drug should not be considered as a first line of defense drug for those with Type 2 diabetes and that those with a history of pancreatitis or thyroid cancer should consider one of the older types of diabetes drugs.

Victoza FDA Warnings
In the first seventeen months following the FDA approval of Victoza some 200 adverse reports came in to the FDA; because it is generally accepted that only 10% of consumers will report adverse health events to the FDA, the numbers were likely significantly higher. Public Citizen believes the risks of Victoza far outweigh the clinical benefits. Some research indicates that pancreatitis can occur from four to six times more often among Victoza users and pancreatic cancer approximately 2.9 times more often.

Victoza FDA Safety Concerns
Even though the FDA approved Victoza they did ask that Novo Nordisk provide a Risk Evaluation and Mitigation Strategy and a five year epidemiological study of the dangers related to Victoza. More recently the FDA took the relatively unusual step of opening a review of diabetic drugs including Victoza. The consumer advocacy group, Public Citizen asked the FDA in 2012 to remove Victoza from the market as it created a substantial risk of causing pancreatitis, pancreatic cancer, kidney failure, severe allergic reactions and pancreatic cancer.

Was There a Victoza Failure to Warn?
The FDA allowed Victoza to add data to their product label in 2012 stating Victoza demonstrated superior efficacy over Januvia, however also required that the potential risks of Victoza be stated on the label. Consumers were warned to speak with a doctor if they developed a lump or swelling in the neck, hoarseness, shortness of breath or trouble swallowing. This new labeling even warned patients that pancreatitis could result when taking Victoza and that the symptoms of pancreatitis could potentially be severe or even fatal. When lawsuits begin to be filed, it is likely many will allege a failure to warn on the part of Victoza’s manufacturer.

Will There Be a Victoza Potential Recall?

It is widely believed that a Victoza recall is only a matter of time and that lawsuits will follow, however at this time no recall has been issued and only two lawsuits have been filed, which also include the drugs Januvia and Byetta. Two patients developed pancreatic cancer after taking all three drugs for a number of years and have filed suit against all three manufacturers. Patients with a valid claim against the manufacturer of Victoza should speak to an experienced Victoza pancreatic cancer attorney.

Friday, July 19, 2013

Some Frequently Asked Questions about Victoza Answered

Those who take Victoza are likely anxious regarding whether the drug is truly safe. Recent reports of patients taking the drug who developed serious adverse health symptoms and a call by an advocacy group, Public Citizen, for the removal of the drug have created anxiety among users regarding their own health. Victoza was approved by the FDA in 2010, against the protests of three members of the panel. Like other new drugs used in the treatment of Type 2 diabetes, Victoza mimics GLP-1 in the body—a naturally-occurring hormone.

GLP-1 is responsible for stimulating the pancreas, triggering cells to absorb sugar from the bloodstream and allowing the pancreas to release insulin. Unlike the other similar drugs, Victoza has also been found to slow the emptying of food from the stomach, thereby causing weight loss. Novo Nordisk, the manufacturer of the drug is currently attempting to have Victoza approved as a treatment for obesity by 2014, however in light of the adverse health effects related to the drug, that approval may not occur.

Victoza and Pancreatic Cancer
A study published in the journal Diabetes in May, 2012, concluded that Victoza could be responsible for stimulating the production of precancerous cells in the pancreas. It is believed that those patients who have abnormalities of the pancreas are then more likely to develop pancreatic cancer. Pancreatic cancer is also more likely among those who have repeated bouts of pancreatitis which causes inflammation of the pancreas. Public Citizen, a consumer advocacy group, reported twenty-eight cases of pancreatic cancer among Victoza users as opposed to only one case among a group taking another drug.

EHealthMe, reported just this April that 11,308 people have suffered significant side effects while taking Victoza. Of those, eighty-three developed pancreatic cancer. The Stanford University publication, High Wire, printed an article discussing acute pancreatitis and the relationship to Victoza in 2012. One case detailed a 53-year old man who came into the ER with symptoms of acute pancreatitis after having his dosage of Victoza doubled. After Victoza was discontinued, his symptoms ceased within eight days.  

Victoza and Thyroid Cancer
On April 19, 2012, Lawyers and Settlement reported the risk of thyroid cancer among those taking Victoza. At the time Victoza was approved in 2010, animal studies showed a significant correlation between Victoza and the development of a rare type of thyroid cancer known as medullary thyroid cancer. Those same studies linked Victoza to thyroid gland tumors, particularly at higher dosages. Researchers at the time were unable to statistically prove significant risk to humans, therefore while the drug was approved the FDA required Novo Nordisk to include a black box warning label which cautioned those with a personal or family history of thyroid cancer to avoid Victoza.

Is a Victoza Recall on the Horizon?
Despite Public Citizen’s demand for a recall of Victoza, there is currently no such recall in the works. But it is possible a recall could be issued if the number of adverse reports coming in to the FDA increases. If you or a loved one has been injured by Victoza, it could be beneficial for you to speak with a knowledgeable personal injury attorney and discuss the options for your future.

Wednesday, July 17, 2013

What are Victoza Dangers? A Discussion on Pancreatic Cancer and Thyroid Cancer



Victoza Diabetic Drug Dangers
Victoza is a drug manufactured by Novo Nordisk and used in the treatment of Type 2 diabetes. Victoza is injected once-daily, with or without food. The dosage is not dependent on what you eat or how active you are. Other injectable drugs of this type must be injected twice-daily, before breakfast and before dinners, so many of those with Type 2 diabetes enjoy the flexibility of Victoza. Unfortunately, after gaining FDA approval in 2010, adverse reports began coming into the FDA regarding serious side effects from the drug. While only about 200 such reports were sent to the FDA in the first year, it is generally agreed that only about 10% of those who suffer negative health symptoms from a drug or medical device will contact the FDA. This means there are significantly more Victoza users who have had adverse health effects from using the drug.

Victoza Pancreatic Cancer and Victoza Pancreatitis
Several studies have pointed to much more serious side effects among Victoza users, primarily pancreatitis and pancreatic cancer as well as thyroid cancer and kidney problems. A study which was reported in eHealthMe and was based on statements sent to the FDA showed that as of June 14, 2013, 11,308 people have reported adverse side effects from Victoza. Eighty-three of those patients developed pancreatic cancer which is widely considered one of the most difficult cancers to treat. A study reported in Gastroenterology places the risk of pancreatic cancer among users of drugs similar to Victoza at 2.9% higher than among those taking an older diabetic drug.

Doctors believe Victoza activates the GLP-1 receptor proteins which in turn stimulates the production of pre-cancerous cells. Those people who had pancreatic abnormalities which otherwise would have remained dormant could have those abnormalities stimulated by Victoza. A history of acute pancreatitis or chronic pancreatitis makes patients much more likely to develop pancreatic cancer; studies show a risk factor of six times the norm among Victoza users.

Victoza Thyroid Cancer
The same GLP-1 receptors also reside in thyroid tissue, a possible explanation for the higher-than normal rates of thyroid cancer among Victoza users. At this juncture only studies on laboratory animals have been conducted regarding an increase in thyroid cancer. The FDA has asked Novo Nordisk to engage in a five-year study regarding risks of thyroid cancer, pancreatitis and pancreatic cancer among Victoza users, and while the drug company is complying with that request, many believe the 9,000 patients currently enrolled in the study are simply not enough to ensure valid results.

Victoza Diabetes Medication Side Effects
“Normal” Victoza side effects include gastrointestinal issues such as nausea, diarrhea, vomiting, constipation, abdominal pain, pancreatitis, anorexia, headaches, dizziness and decreased appetite. More serious side effects which require you to seek emergency medical care include: a lump in the throat regions, changes in urination, shortness of breath, weakness, confusion, fluttering heart or pounding heartbeat, unusual swelling, signs of infection or flu-like symptoms, and any unusual bruising or bleeding.

Victoza Side Effects
Side effects of Victoza which are considered normal include nausea, diarrhea, headaches, dizziness, loss of appetite, abdominal pain, diarrhea or constipation, vomiting, pancreatitis and anorexia. Other potential side effects of Victoza which require doctor’s care include hoarseness, throat lumps, shortness of breath, excessive urination or a lack of urination, flu-like symptoms or signs of infection, a pounding heart or fluttering heartbeat, unusual swelling or any type of bruising and bleeding which does not seem normal. Any of these side effects should be taken very seriously.

Victoza Pancreatic Cancer Lawyers
If you or a loved one has experienced any adverse health effects after beginning Victoza, it is important that you speak to your doctor immediately. After speaking with your physician, it could be to your benefit to contact a Victoza lawyer who can look out for your future and pursue compensation to cover your medical expenses, lost wages and any pain and suffering you have experienced.