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.

No comments:

Post a Comment