Advocacy Group Calls on FDA to Recall Victoza

A public watchdog group has petitioned the Food and Drug Administration (FDA) to remove the Type 2 diabetes injection drug Victoza from the market because it likely increases the risk a patient will suffer thyroid cancer or pancreas and kidney failure.

According to an AP report this week, Public Citizen tells the FDA the risks associated with Victoza are much greater than any potential benefits a diabetic may glean from the drug and that other similar drugs should be taken instead. In fact, the advocacy group believes the market is flooded with drugs similar to Victoza – close to a dozen comparable drugs – that patients needn’t worry about the risks associated with this drug when they could take a drug proven to carry less risk of side effects.

Public Citizen believes there is ample evidence suggesting the dangers Victoza poses to diabetics and that the FDA’s own review panel even had reservations before it was ultimately approved for use in 2010. Three scientists on an FDA advisory panel reviewing Victoza for approval made recommendations against that action because of reports the agency had collected regarding the drug’s link to thyroid tumors, causing the side effect in lab animals during testing.

The FDA acted against the advice of that minority faction of its panel and voted to approve the drug, adding another drug to the available treatments in that class of drugs despite several other, safer options already available. Public Citizen also cited evidence that Victoza was also associated with other side effects in addition to its likelihood to cause thyroid tumors.

Currently the FDA only warns people with a family history of thyroid diseases to avoid taking Victoza. The agency does not believe causing a side effect in an animal study correlates to human patients.

The group points to studies which indicate a 3.7-times increased risk of developing pancreatitis and knows the FDA has received more than 200 reports of people taking Victoza during its first year and a half on the market have developed this condition.

Victoza is in a class of drugs known as glucagon-like-peptide-1 (GLP-1). It works to treat Type 2 diabetes by lowering blood sugar. Type 2 diabetes is bordering on epidemic proportions in the U.S. and despite a flood of prescription drugs available to treat the disease, still about 150,000 Victoza prescriptions are filled each year for it.

Last year, Novo Nordisk, the makers of Victoza, issued a letter to prescribing physicians alerting them to the potential risks of taking its drug, namely its possible link to thyroid tumors and pancreatitis.

Public Citizen petitions the FDA regularly on potentially dangerous prescription drugs or matters that affect public health. The agency is not forced to act on any of the petitions but at the very least, it helps raise more attention to the potential dangers of the products it notes. In some cases, Public Citizen has been forced to file a lawsuit against the agency to get it to act on one of its petitions.

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