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Began Tymlos 4 wks ago; flying solo till I see Endo in 3wks... advice?
Osteoporosis & Bone Health | Last Active: Dec 7 5:53pm | Replies (25)Comment receiving replies
@gently this has come up before: can you share any info on the two year limit for Tymlos being lifted? It was lifted for Forteo but I have read that for Tymlos, only the osteosarcoma black box warning was lifted, not the two year limit. This is important for me and a lot of us.
I read that Lilly put the money, time and research staff into establishing safety of Forteo for more than two years, but that it is unlikely Radius will do so.
Here is an article on extended use for Forteo (and the lifting of the warning and the time limit)
https://www.ccjm.org/content/88/9/489#:~:text=In%20November%202020%2C%20the%20US%20Food%20and%20Drug,potential%20risk%20of%20osteosarcoma.%201%20The%20lifetime%20limitat
There is a lot of misinformation and outdated information online of course. I would be happy if the time limit was also lifted for Tymlos but I have not seen anything about that.
Replies to "@gently this has come up before: can you share any info on the two year limit..."
windyshores,
I'm not thinking there will ever be such a link. No one will conduct studies.
The FDA approved Tymlos on the basis of one clinical trial. The suspicion of osteosarcoma was directed from the Forteo rats and the two year limit was because of that caution. It remains in the Forteo insert that Forteo should only be given for more than two years in select patients likely to benefit, i.e., those with high fracture risk.
One doctor told me that the third year is similar to off label use, another said that he almost never prescribes medicines as recommended in inserts. He thinks the doses are often too high for women of little weight.
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This is from Radius brochure dated 9/24.
"You should not use TYMLOS for more than 2 years over your lifetime."