Should healthcare professionals be aware of any safety issues associated with Victoza?
A. FDA approved Victoza because the Agency believes that the benefits of this drug to patients with T2DM outweigh potential risks associated with its use. There were, however, several safety concerns identified during the Victoza review that had to be evaluated in light of its benefits. These safety concerns included: • Clinical trials that suggested Victoza may be associated with pancreatitis (see Q3). Other drugs that work through similar mechanisms as Victoza have also been associated with pancreatitis. • Animal data that showed a rare type of thyroid cancer known as medullary thyroid cancer associated with liraglutide, although the relevance of this finding to humans remains unknown (see Q5). To ensure that the benefits of Victoza continue to outweigh any risks, FDA has required a Risk Evaluation and Mitigation Strategy (REMS) as part of the Victoza approval. This REMS includes a patient Medication Guide and a Communication Plan. FDA has also required additional studies to better u
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