FDA Petitioned to Pull Novo Diabetes Drug

FDA Petitioned to Pull Novo Diabetes Drug

April 20th, 2012 // 12:53 pm @ jmpickett

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In a petition filed with the FDA, Public Citizen is asking the agency to withdraw the Victoza diabetes treatment sold by Novo Nordisk due to increased risks that patients may developed pancreatitis, serious allergic reactions and kidney failure. And citing internal agency documents, the consumer watchdog notes that Victoza was approved in early 2010 against the advice of two FDA pharmacologists and an FDA clinical safety who reviewed pre-approval studies.

Last June, the FDA had issued new warnings linking the drug to pancreatitis, thyroid cancer and renal failure. At the time, the agency noted Victoza causes both “dose-depedendent and treatment-duration-dependent” thyroid tumors at clinically relevant exposures in both genders of rats and mice, although it was unknown whether the drug causes tumors in humans. But the possibility could not be ruled out by studies. There were also more cases of pancreatitis in patients treated with Victoza than in patients treated with other meds (see this).

In arguing its case, Public Citizen maintains 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 calls this a “striking warning sign” and adds that thyroid cancer was increased 3-fold and thyroid C-cell hyperplasia rose 2.4 times in Victoza patients, compared to those taking other diabetes drugs (here is the petition).

Meanwhile, the watchdog group says a review of the FDA adverse event database found 200 patients were diagnosed with acute pancreatitis during the first 17 months that Victoza was available, suggesting a larger number of cases actually exists. Public Citizen adds that the FDA required Novo Nordisk add a warning on labeling about “acute renal failure and worsening of chronic renal failure” and later required another about serious allergic reactions that may require immediate medical attention.

“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,” Sidney Wolfe, who heads Public Citizen’s Health Research Group, says in a statement. “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.”

For its part, Novo Nordisk rejected the assertions. “When it approved Victoza two years ago, the FDA had before it a large amount of data, including clinical trials in nearly 4,000 patients. As part of its usual process, it carefully assessed all of the data and approved Victoza with labeling that informs physicians and people with diabetes about the appropriate use of the product,” the drugmakers says in a statement sent to us.

“In the two years since Victoza was approved, Novo Nordisk has continued to work closely with the FDA and the medical community to monitor the benefits and appropriate use of Victoza. Our experience in those two years does not support the Public Citizen call to deprive patients of the benefits of Victoza. Indeed, the FDA just recently approved the expanded use of Victoza.”

Public Citizen, however, maintains that Curt Rosebraugh, the director of the FDA Office of Drug Evaluation II, overruled agency reviewers who were against Victoza approval and said 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 only the latest challenge that Novo Nordisk faces in promoting diabetes treatments. The drugmaker, you may recall, recently found itself mired in controversy after signing Paula Deen, the self-styled ‘Queen of Southern Cuisine’ as a spokeswoman for Novo Nordisk, even though Deen failed to disclose she learned three years ago that she has diabetes, but meanwhile served up unhealthy meals on her Food Network show