Victoza FDA Warnings

FDA

With over 26 million people in the United States alone affected by diabetes, the market for new diabetic drugs has grown significantly over the past few years. Unfortunately, it appears that some of America’s top-selling diabetic drugs may be tied to an increased risk of pancreatitis, pancreatic cancer, thyroid cancer, kidney disease and severe allergic reactions. Because of the growing number of adverse health reports regarding these type-2 diabetic drugs the FDA took the unusual step of opening a review of diabetic drugs from Merck & Co., Bristol-Myers Squibb and Novo Nordisk. These pharmaceutical giants are the manufacturers of Januvia, Byetta and Victoza—all drugs which aid in the treatment of type-2 diabetes.

While Januvia is taken in pill form, Byetta and Victoza come in an injectable pen. A consumer watch group, Public Citizen, could be partially responsible for this latest investigation into these drugs. This group has asked the FDA to immediately remove Victoza from the market because it puts patients at a higher risk of developing thyroid and pancreatic cancer, pancreatitis, kidney issues and serious allergic reactions. The group believes these risks far outweigh the clinical benefits of Victoza. Clinical trials—though conducted among small numbers of patients—showed a pancreatitis occurred nearly four times as often among Victoza users. In fact, in the first 17 months following Victoza’s approval reports of 200 patients diagnosed with acute pancreatitis were entered into the FDA database.

In 2008, the manufacturer of Victoza, Novo Nordisk, filed for regulatory approval of Victoza (liraglutide) in both the United States and Europe. At the time of the filing, a study of approximately 6,500 people had been concluded—4,200 of which had received Victoza. No undue adverse effects were noted. Victoza is a once-daily medication for the treatment of type-2 diabetes which mimics the naturally occurring hormone in the body GLP-1. Victoza works by triggering the release of insulin when glucose levels are high and by inhibiting the appetite. In April of 2009, Novo Nordisk announced the FDA had finalized discussions of questions related to Victoza and had voted on questions related to the risk profile of the drug.

Novo Nordisk is one of the more than one dozen companies developing medications to combat diabetes—and to take their place in the $5.1 billion dollar U.S. diabetes drug market. During this 2009 meeting of the FDA panel, experts were split down the middle—6 to 6—on whether to approve Victoza in light of studies showing it caused cancerous thyroid tumors in laboratory animals. The panel eventually agreed to note that Victoza should not be considered the first line of defense in the treatment of type-2 diabetes, approving the drug over the objections of several panel members.

In April, 2012, after Victoza had been on the American market for approximately two years, the FDA granted Novo permission to update their product label to include data which demonstrated the safety and efficacy of adding insulin or metformin to treatment with Victoza. The Corporate Vice-President of Diabetes Marketing at Novo noted, “We’re pleased to expand the Victoza product label to include data demonstrating superior efficacy over Januvia.”  This updated labeling included information regarding potential risks of Victoza and warned consumers to speak with their doctor should they develop a lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath. The label also warned consumers that pancreatitis may be severe and could even lead to death.

The latest Victoza FDA guidelines recommend patient monitoring for those taking Victoza and cautions patients taking the drug to be alert for symptoms such as persistent abdominal pain, particularly when the pain radiates to the back and is accompanied by vomiting. The Victoza FDA stance casts a cautious approach in those patients with a history of pancreatitis or for those with a family history of thyroid cancer. For those patients who have suffered harm from Victoza—a drug they believed to be safe—seeking qualified legal advice could be beneficial. The attorneys of Sullo & Sullo are zealous advocates for their clients, working tirelessly to ensure their clients receive the very best legal representation possible. We will thoroughly assess the particulars of your case then clearly lay out your options regarding a lawsuit against Novo Nordisk for failure to warn consumers of the potential risks associated with Victoza. The Sullo & Sullo law firm has a solid reputation and will always go the extra mile for their clients.

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