Prolia black box warning?

Posted by cpd54 @cpd54, Feb 21 6:36am

FYI,
https://m.youtube.com/watch?v=sZPSWZocbJw

*Moderator Note*

Dr. Susan Brown is listed as a medical anthropologist and certified Nutritionist. Medical anthropology is the study of how health and illness are shaped, experienced, and understood in the context of cultural, historical, and political forces. Dr. Brown is the author of Better Bones and also a retailer. The boxed warning on Prolia specifically focused on the risk to patients with kidney disease and those on dialysis. 

When making treatment and medication choices, it is highly recommended to speak with an endocrinologist.

Additional reading - https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-revises-labeling-amgens-drug-treat-bone-loss-2024-01-19/

Interested in more discussions like this? Go to the Osteoporosis & Bone Health Support Group.

@formisc

I hope you will be able to get an early appointment. Because ideally, you want to do your BTM (and DXA if due) before starting on a new drug

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Okay, here's where I am now... I have heard back from my respirologist, who concurs that coming off Prolia is a "reasonable course" due to the infections. "the only way to know is to stop and try another drug" to see if there is a difference. [as my lung problems could be doing this by themselves]. However when the pattern of shots / infections is so strong, it is a good thing to try.
My appointment with the G.P. is on 13 March, no change there, but that date is one month and 3 days before my six month date for the fourth Prolia shot [which is not going to happen now] So, a perfect moment to do the bloodwork and commence the medication [Fosamax or Reclast] to mitigate the rebound phenomenon.
This week I am due to see the Pharmacist to get her take on the medication choices.
I will get back to you to give you my report on all goings-on !
Thank you and all the best to all who are in this challenging place! Christine

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@formisc

I hope you will be able to get an early appointment. Because ideally, you want to do your BTM (and DXA if due) before starting on a new drug

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I seem to have answered under the "Support for those quitting Prolia".
All is well.

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@thisoldewe

Okay, here's where I am now... I have heard back from my respirologist, who concurs that coming off Prolia is a "reasonable course" due to the infections. "the only way to know is to stop and try another drug" to see if there is a difference. [as my lung problems could be doing this by themselves]. However when the pattern of shots / infections is so strong, it is a good thing to try.
My appointment with the G.P. is on 13 March, no change there, but that date is one month and 3 days before my six month date for the fourth Prolia shot [which is not going to happen now] So, a perfect moment to do the bloodwork and commence the medication [Fosamax or Reclast] to mitigate the rebound phenomenon.
This week I am due to see the Pharmacist to get her take on the medication choices.
I will get back to you to give you my report on all goings-on !
Thank you and all the best to all who are in this challenging place! Christine

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That sounds like a great plan! As mentioned earlier, if you do not want to commit to a prescription of Alendronate yet, you could just try a couple of weeks to gauge your reaction, if any. But remember to do the blood tests first. Oh, you may also want to consider bringing forward your DXA so that you can separate the effect of Prolia and your subsequent relay drug on bone density

Reclast is the more potent drug and is most often quoted for use as a relay drug for getting off Prolia esp after 4 (per Dr McCormick, 3) or more shots of Prolia. But i was wary of putting in 1 year's dose at 1 go so i opted for weekly Alendronate where timing is also less of an issue. If you do end up deciding on Reclast, there is a lot of advice on this forum on how to minimise any side-effects like drinking lots of water. Also, windyshores (search under "Members") mentioned that she would ask for a 20% test dosage first so i am not sure if that is something your doctor would consider or agree to
All the best to you and please do keep us updated!

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@thisoldewe

Okay, here's where I am now... I have heard back from my respirologist, who concurs that coming off Prolia is a "reasonable course" due to the infections. "the only way to know is to stop and try another drug" to see if there is a difference. [as my lung problems could be doing this by themselves]. However when the pattern of shots / infections is so strong, it is a good thing to try.
My appointment with the G.P. is on 13 March, no change there, but that date is one month and 3 days before my six month date for the fourth Prolia shot [which is not going to happen now] So, a perfect moment to do the bloodwork and commence the medication [Fosamax or Reclast] to mitigate the rebound phenomenon.
This week I am due to see the Pharmacist to get her take on the medication choices.
I will get back to you to give you my report on all goings-on !
Thank you and all the best to all who are in this challenging place! Christine

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Good evening @thisoldewe, thanks for updating your medical status. I will be looking forward to reading about your 13 March appointment. In the meantime, here is the information about Fosamax that was given to me by my Mayo Clinic endocrinologist. He helped me leave Prolia effectively.

"Alendronate (Fosamax) is a common osteoporosis medication that reduces your risk of developing an osteoporotic fracture. It also generally increases your bone mineral density by reducing the amount of bone that is being broken down.

"Alendronate is taken once weekly for five years in many, but up to ten years in patients with severe osteoporosis. After five years, whether or not to continue taking this should be discussed with the prescribing provider. This medication offers continued benefit even after you stop it since it does not "wear off" immediately after stopping like some other osteoporosis medications.

This medication should be taken on an empty stomach, first thing in the morning with a full glass of water. Do not take it with other pills, food, or other fluids since they will limit your body's ability to absorb this medication. If you forget to take alendronate on your usual day, simply take it the following day and then resume on your usual day. The medication does not have to be exactly seven days apart to be effective. If you don't take this medication, it will not work. Do not lie down after taking this medication since it can cause erosions in the esophagus if you do this."

May you be safe, protected, and free from inner and outer harm.
Chris

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Thank you so much for your thoughtful words.
I will be updating after my 13 March appointment. On that date, I will be at 'five months since last Prolia shot', so no time for a endocrinologist appt although the referral will be made at that point.
I am so hopeful that this will improve my lung health by halting the constant lung infections.
Will let you all know of my progress!
Christine

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@thisoldewe

Thank you formisc for your info and support.
Yes, I am realising just how critic my timing is at this very moment... but I cannot get an appointment until 13 March.
I am very thankful for the Connect buddies who have educated me on this problem and my arthritis specialist who picked up on my track record since the Prolia started. --- the timing of the past 1 1/2 years is suspicious, when even for me that is a lot of infections, when I am practising such high levels of lung hygiene and isolation from people and masking at all times!
May I ask another question: What are the BTM tests that you are mentioning??
Thanks again for your input. [isn't Connect great?]

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Yes, Mayo connect is amazing!!!

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@cella65

Has anyone gone off prolia. I have had 1 shot of prolia and can’t imagine continuing this drug. Fosamax was no better if not worse. At 78 I can’t see spending the rest of my life such misery.

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What's wrong with the shots? Pain? Marks? ?

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@bobweller

What's wrong with the shots? Pain? Marks? ?

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Bob what are you trying to say?
I’m a wimp? I have any marks on my body and experienced much pain. I’m thinking you are a male and will probably never experience the effects of osteoporosis meds.
Maybe you should do more research on this subject!

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@cella65

Bob what are you trying to say?
I’m a wimp? I have any marks on my body and experienced much pain. I’m thinking you are a male and will probably never experience the effects of osteoporosis meds.
Maybe you should do more research on this subject!

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Sorry you interpreteed my question the wrong way. I ask you what black box? Explain please. I am a 2 tone organ transplant patient for the past 24 years. I have other issues too. I read a lot of science and medical articles. I am very aware of medical side affects, I have too. And I read about Proila plus other bone meds side affects. I am sorry you have had these negitive affects.

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I just want to remind everyone that Prolia is an incredible and very unique drug to help people with osteoporosis. There is no other drug on the market that you can take for long periods of 10+ years and continue to see improvement in BMD in both the spine and the hip. And as far as transitioning off Prolia, it's not much different than any of the osteoanabolic drugs like Evenity, Tymlos or Forteo. You just need to be aware of the rebound you will see after stopping and account for it in your treatment. If you are on Prolia for 2.5 years or less, you can expect to hold BMD levels by switching immediately over to Fosamax or ReClast. If you are on Prolia 3+ years, you should plan on losing about 5% BMD (1/2 of a T-score), and that is also with an immediate transition to Fosamax or ReClast. This information is from a Dr. Serge Ferrari presented in September 2023 at the 9th Central European Congress of Osteoporosis.

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