← Return to Evenity Advice?

Discussion

Evenity Advice?

Osteoporosis & Bone Health | Last Active: Oct 23 8:52am | Replies (121)

Comment receiving replies
@normahorn

How many have seen that Australia has upped their warnings on heart issues with Evenity?
https://www.tga.gov.au/news/safety-updates/new-warnings-romosozumab-evenity-cardiovascular-risks

Jump to this post


Replies to "How many have seen that Australia has upped their warnings on heart issues with Evenity? https://www.tga.gov.au/news/safety-updates/new-warnings-romosozumab-evenity-cardiovascular-risks"

@normahorn this info doesn't look new but seems to reiterate the results of the FRAME and ARCH studies. It looks like they did add some new language to expand the warning but it is still based on the same two studies. From your linked update:

"The Australian, European Union and United States product information documents all describe the results of 2 pivotal studies providing data about the potential risk of major adverse cardiac events associated with romosozumab.1,2 There was a higher rate of major adverse cardiac events (a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke) associated with romosozumab in one trial but not the other. The disparity between these 2 trials has been a focus for regulators assessing the safety of this medicine."

I have seen one article that accounts for the difference between Evenity and alendronate as being due to cardiovascular protective factors from alendronate use, and another article claiming it was due to chance. Clearly more research is needed.

I also have read that while cardiovascular risk has been the focus of research on Evenity, the effects of inhibiting sclerostin throughout the body have not been adequately studied (bone marrow inflammation, B cell suppression, osteoarthritis etc.) But those problems seem not to have emerged in any significant way since it went on the market.

I am cautious: I took it for 4 months and hope to be able to do that again.