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Opinions Split on Victoza

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Washington, DCConcerns about Victoza side effects, including a reported possible link between Victoza and cancer, have led to some critics requesting the type 2 diabetes drug be taken off the market. Not all studies, however, have confirmed the risk of cancer in patients taking Victoza.

Back in 2012, Public Citizen, the consumer advocacy group, petitioned the FDA to remove Victoza (known generically as liraglutide) from the market. Among the reasons cited by the organization to remove Victoza from the market were the reported risk of thyroid cancer, pancreatitis, serious allergic reactions and kidney failure. Public Citizen noted that the risks of Victoza outweighed the benefits.

Furthermore, Public Citizen noted, when Victoza was approved it was done so against the advice of two of the FDA’s own pharmacologists and a clinical safety reviewer. When the clinical safety reviewer (Dr. Karen Mahoney) made a statement against approving the drug, Mahoney noted that because there were already 11 classes of drugs approved to assist with glycemic control in type 2 diabetes, there was no urgent need to approve Victoza given the uncertainty about serious risks.

“Victoza is the only drug approved by the FDA or in the approval pipeline that causes thyroid C-cell tumors in both sexes of rats and mice, doing so at drug exposures similar to those seen in people taking the recommended dose - a striking warning sign,” Public Citizen noted when it sent its petition. The advocacy group also noted that some clinical trials showed a three-fold increase in risks including pancreatitis.

But, those findings conflict with a more recent statement made by the FDA in the New England Journal of Medicine (2/27/14). In that statement, after noting that the FDA and the European Medicines Agency, who co-wrote the statement with the FDA, are concerned about the reports of pancreatitis and pancreatic cancer in patients taking anti-diabetic medications, the agencies found that a causal relationship between incretin-based drugs and pancreatitis or pancreatic cancer was inconsistent with current data. In other words, the FDA and EMA did not find enough evidence of a link between incretin-based drugs and pancreatitis or pancreatic cancer to warrant any action.

That said, the agencies did say they had not reached a final conclusion and still considered pancreatitis a risk of incretin-based drugs. Lawsuits have not been filed concerning Victoza, although lawsuits have been filed concerning other drugs in the incretin-based class.

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