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What information did FDA review about medullary thyroid cancer and Victoza?

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What information did FDA review about medullary thyroid cancer and Victoza?

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A. Studies were done in mice and in rats to look for any evidence that liraglutide might cause cancer in animals. Results of the studies showed that liraglutide caused malignant tumors of the thyroid gland, especially at doses that were 8-times higher than what humans would receive. It is hard to predict whether this finding means that humans who take liraglutide might be at risk for developing medullary thyroid cancer. This specific type of thyroid cancer is very rare in humans (about 600 cases per year in the United States) so even if liraglutide increased the risk for a patient to develop it, cases still might not be detected during the clinical trials. As a result of the animal study results, the clinical development program for Victoza included blood tests for a biomarker for medullary thyroid cancer—a blood calcitonin test. Data from a two-year study did not show any difference in calcitonin levels between patients treated with Victoza compared to other diabetes medicines. With t

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