Regulatory Focus™ > News Articles > Public Citizen to FDA: Diabetes Drug Unsafe, Should Be Pulled

Public Citizen to FDA: Diabetes Drug Unsafe, Should Be Pulled

Posted 20 April 2012 | By Alexander Gaffney, RAC 

The watchdog group Public Citizen is calling on the US Food and Drug Administration (FDA) to yank Novo Nordisk's diabetes drug Victoza (liraglutide) off the market for safety risks it says "outweigh any documented clinical benefits."

After being approved, "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 [thyroid cancer] cases," reports Pharmalot.

Because of the risks associated with the drug, which include thyroid cancer, pancreatitis and kidney failure, Public Citizen is calling on FDA to "immediately remove [the drug] from the market."

Victoza was not approved without controversy, reports The Associated Press. Public Ctizen highlighted the dissenting opinions of two pharmacologists and a clinical safety reviewer on FDA's Victoza review team who recommended the drug not be approved, though it is not unusual for a reviewer to dissent from a decision.

The group also blasted the Director of the Office of Drug Evaluation II, Curtis Rosebraugh, for what it said was wildly inappropriate language for a regulator to use.

When Victoza was being approved, Rosebraugh reportedly stated the "profit-based business" Novo Nordisk was in generated "pressure to generate profit before there is more competition," said Public Citizen.

"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," said Sidney Wolfe, director of Public Citizen's Health Research Group.

Update: Novo Nordisk said in a statement to Reuters it believes Public Citizen's claims are without merit. "We do not expect any consequences for Victoza from Public Citizen's petition," Chief Science Officer Mads Krogsgaard Thomsen said. "There is nothing in it."

Read more:

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

Public Citizen's Citizen Petition

Associated Press - Public Citizen Wants Withdrawal of Diabetes Drug

Pharmalot - Consumer Group To FDA: Pull Novo Diabetes Med

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