Showing posts with label FDA approval. Show all posts
Showing posts with label FDA approval. Show all posts

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.