Cancer risks of Tymlos

Thank you for this answer. It means a lot as I, too, was worried. Thank you.

Thank you all, for you have put my mind at ease after a long weekend of worrying.

I wonder if there are any studies indicating cancer from Tymlos use in humans, and if so, what the percentage is. If Tymlos has been around for 7 years, you'd think they would have some data.

I totally understand @yogagirl57 I'm in the same boat!

@loh naturally there are studies. That is why the black box warning was lifted. There is still a warning (see below from drug insert) but observational studies have not seen any osteosarcoma from use of Tymlos. That means no cases observed. Ditto with Forteo which has a similar mechanism. I had breast cancer in 2015 and had no concerns about taking Tymlos for two years. I needed it!

From the drug insert:

---------------------------RECENT MAJOR CHANGES------------------------
Osteosarcoma Boxed Warning, Removed 12/2021

Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma in male and female rats after subcutaneous administration at exposures 4 to 28 times the human exposure at the clinical dose of 80 mcg [see Nonclinical Toxicology (13.1)]. It is unknown whether TYMLOS will cause osteosarcoma in humans.

Osteosarcoma has been reported in patients treated with a PTH-analog in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of TYMLOS and/or use of a PTH-analog [see Dosage and Administration (2.3) and Nonclinical
Toxicology (13.1)].

Avoid use in patients with increased risk of osteosarcoma including patients with open epiphyses, metabolic bone diseases including Paget’s disease, bone metastases or history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton, and hereditary disorders predisposing to osteosarcoma. (5.1)

Here is a study on Forteo: https://pmc.ncbi.nlm.nih.gov/articles/PMC9465003/

Subsequent investigations included five real‐world studies directed at assessing a connection between teriparatide and osteosarcoma risk in humans. The early studies did not identify an increased risk of osteosarcoma but were inadequate to sufficiently characterize risk, given the low incidence of this rare form of bone cancer. Learning from these efforts, two studies were undertaken using claims data to identify large cohorts of patients treated with teriparatide and assess whether these patients were found to have osteosarcoma by linking pharmacy claims data with data from cancer registries. These studies showed no increase in osteosarcoma in patients using teriparatide compared with unexposed groups, as well as to the expected population‐based background incidence of the disease. Based on this real‐world evidence and the totality of data collected from postmarketing use and other clinical investigations, the label was updated in 2020.

Good luck! I have heard there is a lot of success in bone growth. And, yes, keep us posted....

Just to explain the sentence in the insert about "Osteosarcoma has been reported in patients treated with a PTH-analog in the post marketing setting" but not in observational studies I am posting another quote from a study, the one I linked above on Forteo. Read the whole study or note this quote:

"Given the background rate of 3.2 cases per million per year (derived from NCI‐SEER rate), age‐ and sex‐adjusted to the teriparatide‐treated population, the expected number of cases was 4.17 cases. The study observed 3 cases and an estimated standardized incidence ratio of 0.72 (90% confidence interval [CI], 0.20–1.86).( 7 ) "

So yes people on these meds may develop osteosarcoma. It is a risk without the meds at an expected rate of 4.17 cases per million per year.

The black box warning was about osteosarcoma but that is not the only bone cancer. I was not interested in daily injections, knowing my track record on daily medications, so I did not pursue the comment made by an Endo who said that Forteo/Tymlos might be countraindicated for me due to my CLL, a bone marrow cancer. My hope is that nothing will cause this to advance so I can avoid any treatments. It has been stable for at least 2 years and I like it that way.

Thank you so much!

@yogagirl57 My endocrinologist told me the same about Tymlos. I am a cancer survivor and. had radiation therapy so he said no Tymlos for me. He recommended Evenity and I'm going for my 12th and last injections of Evenity tomorrow. I've had no side effects with Evenity. I meet with my endocrinologist again at the end of November after a bone density scan. We will then talk about next step to hopefully "lock in" any bone density gains I have made on Evenity.