Victoza Recall Request Dismissed by Drug Maker

A recent petition filed to remove Victoza from the market is groundless, according to Novo Nordisk, and the manufacturer of the diabetes drug indicates that it does not expect that the FDA will actually recall Victoza.

Novo Nordisk is rejecting arguments that the benefits provided by the medication are outweighed by the risk of potential Victoza side effects, which the petition indicates may increase the risk of thyroid cancer, pancreatitis and kidney failure.

The prominent consumer advocacy group Public Citizen sent the petition for a Victoza recall last week to FDA Commissioner Margaret A. Hamburg.

According to a report by Reuters, Novo Nordisk officials claim that most of the data cited by Public Citizen was based on tests involving rats and mice during the pre-trial phase, which are allegedly not relevant to humans.

However, Public Citizen pointed out that Victoza is the only drug approved by the FDA that has been shown to cause thyroid C-cell tumors in both sexes of rats and mice, occurring at drug exposures similar to those seen in humans taking the recommended dose. The group claimed that is a “striking warning sign.”

Public Citzen pointed out that the medication was approved in January 2010 against the advice of at least two FDA parmacologists and an FDA clinical safety reviewer. The group also indicated that by June 2011, the FDA required new warnings linking the drug to a potential risk of pancreatitis, thyroid cancer and renal failure.

The petition also highlighted that cases of pancreatitis from Victoza continue to be diagnosed among humans in post-marketing reports to the FDA at alarming rates. In the first 17 months Victoza was on the market, the FDA identified at least 200 patients diagnosed with acute pancreatitis, which likely only represents a small portion of the total number of diagnosed cases.

“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, in a press release issued by the 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.”

Novo Nordisk officials indicate that they do not expect the FDA to act on the petition, maintaining that doctors and patients should remain confident in the drug’s safety. Victoza is one of the drug maker’s top selling medications, generating sales of more than $370 million during the fourth quarter of 2011.