The FDA Victoza warning for pancreas problems including pancreatitis and cancer was released in March of 2013, on the basis of a study published in the Journal of the American Medical Association (JAMA). Since the release of the FDA Victoza warning, the drug has been under ongoing scrutiny to determine whether its benefits outweigh its risks. This page provides full information on the FDA Victoza warning from attorneys providing Victoza lawsuit representation to individuals and families around the nation.
The FDA Victoza warning asserted the drug should not be used as a first-line diabetes treatment because of the health risks, yet it has become one of the best-selling and fastest-growing diabetes drugs in the world. Novo Nordisk has been accused of illegal marketing tactics aimed at downplaying the seriousness of the FDA Victoza cancer warning and rewarding doctors who prescribe the drug. The company settled a U.S. DOJ lawsuit in 2017 to resolve these allegations, paying more than $58 million.
The FDA issued a warning on liraglutide, or Victoza, in 2013. At this time, the federal agency called for the drugmaker, the Danish company Novo Nordisk, to issue a letter to physicians and diabetes specialists about the risk for cancer and pancreas problems from Victoza. In fact, a survey of health professionals found that a significant percentage were unaware of the danger of cancer or pancreatitis from Victoza.
Adverse event reporting revealed a trend in acute pancreatitis cases in patients taking Victoza to regulate blood sugar, as compared to patients taking other medications. As a result, the FDA Victoza warning letter recommended clinicians monitor patients for signs of pancreatitis. Acute pancreatitis is characterized by extreme abdominal pain caused by swelling and inflammation of the pancreas. Persons who have never taken Victoza before or whose prescription has been increased should be monitored closely for warning signs, according to the FDA Victoza letter.
When Victoza was first approved by the FDA in January of 2010, clinical testing showed early indications of the risks posed by Victoza. In fact, the drug was approved despite objections from three safety experts at the FDA, who feared Victoza risks outweighed its benefits. As part of the drug's approval, the FDA required the implementation of a Risk Evaluation and Mitigation Strategy.
Since that time, researchers have learned much more about the dangers posed by Victoza - but warning information has not been passed on to doctors or consumers in an effective manner. As a result, many innocent Americans have suffered from painful and life-threatening conditions such as pancreatic cancer from Victoza. Hundreds of Americans have filed Victoza lawsuits against Novo Nordisk for the company's apparent negligence in publicizing the FDA Victoza warning. The lawsuits have been consolidated as a multidistrict litigation (MDL) in U.S. District Court in California.
This is not the first legal battle Novo Nordisk has faced over the failure to publicize Victoza warning information on pancreatic problems and cancer. In September of 2017, Novo Nordisk paid $58.65 million to settle a suit with the United States Justice Department. This suit consisted of eight claims which alleged Novo Nordisk had engaged in illegal marketing practices, in violation of federal law. Specifically, the company was accused of sending drug sales people, disguised as medical educators, to convince doctors the FDA Victoza warning was false or unimportant. The company was also accused of paying kickbacks to doctors who prescribed the drug.
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