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Last week, consumer watchdog group Public Citizen petitioned the Food and Drug Administration (FDA) to recall Victoza, a diabetes drug, as a result of increased risk of thyroid cancer, pancreatitis, and kidney failure. In its petition, Public Citizen cited internal agency documents that show that Victoza was approved in 2010 against the advice of two FDA pharmacologists and an FDA clinical safety who had reviewed pre-approval studies. In June 2011, the FDA issued new warnings linking the dangerous drug to thyroid cancer, pancreatitis, and renal failure.

Public Citizen argues that 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.” The group states that this is a “striking warning sign” and cites a marked increase in thyroid cancers and thyroid C-cell hyperplasia in patients using Victoza when compared to patients using other diabetes drugs. 

Public Citizen’s Sidney Wolfe stated “The FDA’s frequent solution to serious safety issues identified with new drugs is reckless: The agency simply describes the risks in the drug label and hopes that physicians and patients will pay attention. But more and more people are taking this drug, and more people are experiencing serious health problems as a result. Clearly, the FDA’s warning system is not sufficient. The drug should be taken off the market.”

The drug manufacturer, Novo Nordisk, maintains that its drug was approved by the FDA after sufficient clinical trials and reported that the FDA had recently approved the “expanded use” of Victoza.

Public Citizen countered that the director of the FDA Office of Drug Evaluation II overruled FDA reviewers who opposed approval of Victoza, stating that “while many sponsors may responsibly introduce a drug into marketing, theirs is a profit-based business and the pressures to generate revenue are strong. Also, with most classes of drugs, there are similar drugs in development from competitors which places even more pressure to generate profit before there is more competition.”

Source: Pharmalot, “Consumer Group to FDA: Pull Novo Diabetes Med,” Ed Silverman, April 20, 2012.