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FDA Issues Victoza Alert for Thyroid Cancer, Pancreatitis

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Clinical trial results suggest diabetes drug Victoza may increase the risk of thyroid cancer and pancreatitis, says the U.S. Food and Drug Administration (FDA). The agency issued a warning based on clinical trial results showing Victoza caused “dose-dependent and treatment-duration-dependent thyroid C-cell tumors” in female and male rats and mice.

According to the FDA, it is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans but the chance has yet to be ruled out by any clinical or nonclinical studies. Researchers also found an increase of papillary thyroid carcinomas in exposed animals, reported MedPage Today.

Victoza is a new Type-2 diabetes drug consisting of daily injections of synthetic glucagon-like-peptide-1 (GLP-1). The body chemical GLP-1 is released by the liver in response to food in order to increase the secretion of insulin which limits the elevation of blood sugar following meals, explained the FDA. The drug is designed as a supplement to diet and exercise to lower glycemic levels in adults with Type-2 diabetes.

The drug’s manufacturer, Novo Nordisk, is monitoring cases of MTC to determine if there is any increase in MTC incidences related to Victoza, says the Risk Evaluation and Mitigation Strategy issued by the FDA. The agency mandated that Novo Nordisk mail a letter to healthcare professionals once the company has determined physicians are not aware of the increased risk of thyroid cancer, reported MedPage Today.

In January 2010, the FDA approved Victoza despite the split vote of the advisory committee that reviews animal studies and clinical safety. The 2010 approval announcement revealed that in five clinical trials examining roughly 3,900 patients, those taking Victoza developed pancreatitis, or inflammation of the pancreas, more often than patients who were taking other diabetic medications. Based on the clinical trial results, the FDA only approved second-line use for Victoza including a label warning about thyroid cancer and a “second-line indication” which means “other drugs should be preferred.” Just nine months after agency approval, almost 200,000 prescriptions for Victoza were dispensed.

The FDA advises new Victoza patients, or those receiving an increased dosage, to pay attention to symptoms such as persistent severe abdominal pain or back pain accompanied by vomiting, which are indicative of pancreatitis.

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