Here are five things to know:
1. The FDA Safety Communication stated the FDA mandated the drug manufacturer to strengthen the warning about the drug’s potential effects on the bone.
2. In the initial study submitted to the FDA to gain approval for Invokana, the findings revealed the drug may increase the risk of bone fracture and decrease mineral density. Although the FDA approved the drug, it required the drug manufacturer to conduct further studies to obtain more data on how the drug may impact bones.
3. One of the trials indicated changes to bone mineral density over two years. Therefore, the drug manufacturer put more information about the risk of decreased bone mineral on the label.
4. In one of the clinical trials, 714 individuals experienced greater ”loss of bone mineral density at the hip and lower spine than a placebo.”
5. The FDA is evaluating the bone risk associated with other similar drugs.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.