Long before the first FDA Victoza warning was issued, federal regulators expressed concerns about the safety of Victoza. Now, after two FDA Victoza warnings and a Justice Department lawsuit for illegal marketing of the drug, the American public is finally beginning to learn about Victoza risks. This page provides detailed information about the FDA Victoza warnings and Victoza risks for acute pancreatitis and pancreatic cancer.
The first FDA Victoza warnings came in the form of the opinions given by safety experts at the FDA when the drug was first proposed for approval in the United States as a Type 2 diabetes treatment. Three FDA safety officials were not in favor of approving Victoza, stating they believed Victoza risks outweighed its benefits. Victoza was approved despite their concerns, but the FDA drug approval committee did require the adoption of a Risk Evaluation and Mitigation Strategy as well as ongoing Victoza safety studies.
In 2013, the first official FDA Victoza warning was released, three years after the drug hit U.S. markets. This FDA Victoza warning was prompted by study resulted published in the Journal of the American Medical Association (JAMA) which indicated that taking Victoza exposed patients to a heightened risk for both pancreatitis and pre-cancerous cell growth in the pancreas. Both acute pancreatitis and pancreatic cancer are severe and potentially life-threatening diseases. A warning about the heightened risk for pancreas problems from Victoza was added to the drug label.
Despite the public nature of the 2013 FDA Victoza warning, many doctors and patients did not take the threat seriously. There is a clear reason for this: Novo Nordisk, along with several other companies that sell incretin mimetic pharmaceutical drugs, were embroiled in a major lawsuit with the U.S. Department of Justice. Specifically, Novo Nordisk paid $58 million related to allegations of illegal marketing practices, launching doctor-education campaigns to downplay the seriousness of the FDA Victoza warning. Doctors were told the warning was untrue or not a serious risk; simultaneously some physicians were paid kickbacks for favoring Victoza over other (safer) drugs. Victoza rose to prominence as the best-selling drug in its class, bringing in more than $2 billion in 2014 alone.
Two separate studies have found evidence of a heightened risk for pancreatic cancer from Victoza. In 2013, a study published in JAMA revealed the presence of precancerous pancreas cells in Victoza users. Then, in 2016, a new study known as the LEADER clinical trial concluded that persons taking Victoza were three times more likely to develop pancreatic cancer than persons taking a placebo. To date, the drugâ€™s warning label still does not contain a Victoza cancer warning and many consumers are not aware of the risk.
The FDA Victoza Pancreatitis Warning cautions patients and medical professionals about the risk of acute pancreatitis from Victoza. Acute pancreatitis is a serious medical condition that can result in tissue death, organ system failure, and even fatality. Caused by swelling and inflammation of the pancreas, the condition cuts off the organâ€™s blood supply. The FDA Victoza warning lists sings of acute pancreatitis and warns persons experiencing those symptoms to get medical help immediately.
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