FDA Still Unmoved by Victoza Side Effects

Wilmington, NCIn a letter appearing in at least two newspapers, the former executive director of the North Carolina Board of Pharmacy lamented the tendency for pharmaceutical ads to appear light-hearted and soothing, even though the context of the ad is far more serious. And while David Work of Wilmington was generalizing and not calling out any drug in particular, he used Victoza side effects to illustrate his point.

And his point - pharmaceuticals can have very serious consequences that should not be taken lightly. It behooves the patient to gather as much information on a particular drug as possible from the pharmacist.

“[One] recent ad that got my eye and ear is promoting Victoza, a new drug to treat diabetes,” Work writes in a letter that appeared in The News & Observer (11/26/13). “It had soothing light background music as it proceeds through about two minutes of spoken information.

“Nearly halfway through this oral text is the phrase: ‘serious side effects may happen to people who take Victoza including inflammation of the pancreas or pancreatitis, which may be fatal.’” Victoza Pancreatic Cancer is one of the side effects of Victoza.

“Victoza is not the only pharmaceutical with potentially serious adverse reactions,” Work continues. “But it does illustrate the wisdom of getting all the information available before taking prescription drugs. This and much more information on specific drugs is available from your pharmacist at your pharmacy. Every commercial package of a prescription drug normally has only one package insert so a citizen may need to wait a few days until that document can be obtained by the pharmacist.”

Public Citizen, the consumer advocacy group, would agree with Mr. Work - but Public Citizen has gone one step further, in petitioning the US Food and Drug Administration (FDA) to ban Victoza and get it off the market immediately.

That petition to remove Victoza due to the possibility and potential of Victoza cancer was made in April 2012. Almost two years later, it appears the FDA is unmoved.

Public Citizen noted that Victoza, approved by the FDA in January 2010, was back in the FDA’s sights just 17 months later, in June 2011. That’s when the FDA issued new warnings about the potential for Victoza Thyroid Cancer, pancreatitis and renal failure.

With regard to the potential link between Victoza and cancer, Public Citizen pointed out in its petition that an FDA clinical safety reviewer recommended against approval of Victoza. “The clinical safety reviewer does not recommend approval of liraglutide at this time,” wrote Dr. Karen Mahoney. “In the United States, there are already 11 classes of drugs approved for glycemic control in type 2 diabetes…The need for new therapies for type 2 diabetes is not so urgent that one must tolerate a significant degree of uncertainty regarding serious risk concerns.”

In its petition, Public Citizen noted that Victoza was the only drug approved or competing for approval in the 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 - a striking warning sign. In patients taking Victoza in pre-approval studies, papillary thyroid cancer was increased 3-fold and thyroid C-cell hyperplasia (increased proliferation of such cells) was increased 2.4-fold, compared to patients taking other drugs for diabetes.

“Even in the small numbers of patients in clinical trials, pancreatitis was increased 3.7-fold in patients getting Victoza over that seen in patients getting other diabetes drugs; additional cases of pancreatitis continue to be reported to the FDA in alarming numbers, considering how few adverse events are ever reported,” Public Citizen continued. “In the first 17 months of Victoza being on the market, 200 patients were diagnosed with acute pancreatitis, according to Public Citizen’s review of the FDA’s adverse event database. Because only an estimated 10 percent of cases are reported, potentially as many as 2,000 patients or more have suffered a painful and serious outcome as a result of taking Victoza.”

“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. His comments were issued in April 2012.

To David Work’s point, the need for consumers to pay attention is paramount, given the FDA’s apparent willingness to approve drugs in spite of the potential for grievous adverse reactions such as Victoza Thyroid Cancer and other Victoza side effects. It appears, thus, that consumers are ill-advised to blindly trust a drug simply because it carries FDA approval and has been prescribed by a physician. All drugs have potential side effects, some of which can be dire. One cannot simply assume everything will be okay. Consumers are advised to be more vigilant in knowing what they are ingesting, in order to truly conclude if the benefit is worth the risk…

Victoza is known generically as liraglutide and is manufactured by Novo Nordisk.