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Novo Nordisk's Victoza(R) Receives FDA Approval for Adults With Type 2 Diabetes
Date:1/25/2010

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Important Safety Information

Victoza causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice.  It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies.  Victoza is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).  Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries.  It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors.  Patients should be counseled regarding the risk and symptoms of thyroid tumors.

In clinical trials, there were more cases of pancreatitis among Victoza-treated patients than among comparator-treated patients.  If pancreatitis is suspected, Victoza should be discontinued.  Victoza should not be re-initiated if pancreatitis is confirmed.  Use with caution in patients with a history of pancreatitis.

When Victoza is used with an insulin secretagogue (e.g. a sulfonylurea) serious hypoglycemia can occur.  Consider lowering the dose of the insulin secretagogue to reduc
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