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← Return to Evenity - My Email to FDA
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@windyshores, thanks for your response. There had already been 17 romosozumab related ONJ cases reported to the FDA Pharmaceutical Adverse Events Database by Sept. 2021. From the studies I have read, it *appears so far that Evenity carries about the same ONJ risk as oral bisphosphonates. It's still a small risk for most, but for someone like me who needs an oral bone graft, it is definitely a risk. Also, a study of the data on the FDA site revealed that ONJ risk from Evenity was found to have the earliest onset of all the osteoporosis drugs at 169.5 days into treatment, which is surprising. I know that systemic clearance occurs at 0.38mL/kg/hr-but I need a pharmacist to figure out what that means for me!
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@marymj7 I was wondering how the risk could be high with a drug that was only approved for one year, when the risk with bisphosphonates is (allegedly) after 3-5 years. But the mechanism of sclerostin inhibition is so different from the mechanism of other anti-resorptives.
I wrote somewhere on this forum about the side effects that came as a surprise once bone drugs were on the market: bisphosphonates and atypical fractures/jaw necrosis, Prolia and rebound, and Evenity raising P1NP for only a couple of weeks- all surprises. On the positive side, actual post-marketing experience with Forteo and Tymlos showed on bone cancers.
I wonder if this early ONJ risk with Evenity was expected by researchers and marketers. It is so new. Medwatch/FDA is helpful. Thank you for sharing this! I did Evenity for 120 days but now Reclast- we'll see...I have one problem tooth!
Hope pharmacist, doctor and dentist can work together to make sure your oral surgery is safe!