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April 19, 2012

Public Citizen to FDA: Pull Diabetes Drug Victoza From Market Immediately

Drug Can Cause Thyroid Cancer, Pancreatitis, Kidney Failure 

WASHINGTON, D.C. – In a petition filed today with the Food and Drug Administration (FDA), Public Citizen called on the agency to immediately remove from the market the increasingly prescribed diabetes drug Victoza because it puts patients at higher risk of thyroid cancer, pancreatitis, serious allergic reactions and kidney failure that outweigh any documented clinical benefits.

Victoza (generic name liraglutide, made by Novo Nordisk), was approved in January 2010, against the advice of two reviewing FDA pharmacologists and an FDA clinical safety reviewer. By June 2011, the FDA had issued new warnings linking the drug to pancreatitis, thyroid cancer and renal failure.

In her statement against the approval, the clinical safety reviewer, Dr. Karen Mahoney, said, “The clinical safety reviewer does not recommend approval of liraglutide at this time … In the United States, there are already 11 classes of drugs approved for glycemic control in type 2 diabetes … The need for new therapies for type 2 diabetes is not so urgent that one must tolerate a significant degree of uncertainty regarding serious risk concerns.”  

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. In patients taking Victoza in pre-approval studies, papillary thyroid cancer was increased 3-fold and thyroid C-cell hyperplasia (increased proliferation of such cells) was increased 2.4-fold, compared to patients taking other drugs for diabetes.

Even in the small numbers of patients in clinical trials, pancreatitis was increased 3.7-fold in patients getting Victoza over that seen in patients getting other diabetes drugs; additional cases of pancreatitis continue to be reported to the FDA in alarming numbers, considering how few adverse events are ever reported. In the first 17 months of Victoza being on the market, 200 patients were diagnosed with acute pancreatitis, according to Public Citizen’s review of the FDA’s adverse event database. Because only an estimated 10 percent of cases are reported, potentially as many as 2,000 patients or more have suffered a painful and serious outcome as a result of taking Victoza.

Because of other post-marketing reports, the FDA required the manufacturer to place on the label a warning about “acute renal failure and worsening of chronic renal failure.”

The agency later required the drug maker to add still another warning about serious allergic reactions that may require immediate medical attention. Nearly 10 percent of liraglutide-treated patients in the clinical trials had antibodies to the drug, resulting in increased infections (especially upper and lower respiratory tract), injection site reactions and joint pain. Most common, though, are the gastrointestinal adverse events associated with Victoza: nausea, diarrhea, vomiting and constipation – all at least two times higher than in patients using other diabetes drugs. Symptoms involving abdominal pain are especially serious because they can mask the symptoms of renal failure and pancreatitis.

Without adequate data to state otherwise, it is not known if Victoza increases cardiovascular risk, something for which diabetics are already at increased risk.

“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,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “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.”

Approximately 150,000 prescriptions for Victoza are now being filled each month, which translates into almost two million prescriptions a year.

When the drug was being considered for approval, the director of the FDA’s Office of Drug Evaluation II, Curtis Rosebraugh, M.D., overruled his reviewers who were against its approval, sweeping aside their criticisms and explaining in his review of the drug that “[w]hile 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.”

“This is the kind of comment that one would expect from the drug’s sponsor, Novo Nordisk, or from Wall Street – not from a high-ranking FDA official,” Wolfe said.


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