Public Citizen Petitions FDA to Recall Victoza Due to Risk of Side Effects
A petition has been filed with the FDA by the prominent consumer advocacy group Public Citizen, calling for a Victoza recall to be issued to protect diabetics from exposure to a risk of thyroid cancer, pancreatitis, kidney failure and other potential side effects of the medication.
The petition to recall Victoza (PDF) was filed on Thursday, indicating that Novo Nordisk diabetes drug should be removed from the market just over two years after it was first approved.
In the petition to FDA Commissioner Margaret A. Hamburg, Public Citizen says that the risks on thyroid cancer and pancreatitis outweigh any documented clinical benefits.
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Public Citizen points out in its petition that the FDA’s clinical safety reviewer, Dr. Karen Mahoney, warned the agency not to approve Victoza before it was released to the public in January 2010.
Mahoney pointed out that there were a number of diabetes drugs already on the market, and there was no need to expose consumers to risks of Victoza side effects, which caused concerns for some even during its trial stages.
In clinical trials, Victoza users had nearly four times the risk of developing pancreatitis than those that used other diabetes drugs. Public Citizen says that in the first 17 months the drug was on the market there were 200 reports of Victoza users being diagnosed with acute pancreatitis, and the group estimates that, in general, only about 10% of such reports are submitted to the FDA, meaning that there could be thousands of diabetics who have contracted pancreatitis due to Victoza side effects.
In a report released in March 2010, the FDA warned that animal testing revealed possible thyroid cancer links with Victoza, which belongs to a class of drugs known as GLP-1 therapies.
In June 2011, the FDA required new Victoza label warnings that also alerted users to a risk of kidney problems linked to the drug, and later added a warning of serious allergic reactions. Public Citizen also points out in its petitions that some studies indicate an increased risk of birth defects and malformations when the drug is taken by pregnant women.
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