I was just at the Dr to discuss my latest CRP results (better than expected!) and she asked me if I'd had my bi-annual Prolia injection (I have). when I got back to work I thought I'd do a bit of digging and I found a couple of things that make me wonder if Prolia may have contributed to my PMR developing. Just my imagination but is there a coincidence? Anyone else had Prolia injections?
Check this out:
Prolia was approved in 2010 for the treatment of osteoporosis and for preventing new bone fractures especially in postmenopausal women. This new drug modifies the regulatory control of the immune system over bone remodeling. Its cutting-edge design is matched by the ease of its twice-a-year administration. But Prolia is far from the wonder drug it is being promoted as. By modifying the immune system, it impairs general immune response. And curiously, Prolia can kill off the bones of the jaw and cause hip bone fractures.......
The lack of long-term safety studies for Prolia makes it highly dangerous. Reading the product’s safety information on the manufacturer’s website is particularly depressing. Amgen lists a number of horrifying adverse effects of Prolia.
One can only wonder what other side effects are there if the manufacturer admits to such profound damages.
The severity of the identified side effects of this drug makes it even worse than bisphosphonates. And only time will tell what new side effects will emerge in a decade when independent safety studies are published.
Most of the side effects of Prolia are caused by its negative influence on bone remodeling and its interference with the roles of RANKL in the immune system.
RANKL, for example, is required by T helper cells. By inhibiting such immune cells, Prolia increases the chances of infections, hypersensitivity reactions and autoimmune diseases.
Even the FDA raised concerns about the effect of Prolia on important immune cells and cytokines. But then, the regulatory body approved the drug a year later.
While the disruption of the immune system is terrible, the effect of Prolia on bone remodeling is simply unforgivable. Even Amgen admits on the product page that Prolia can cause thigh bone fractures and osteonecrosis of the jaw bone.
Morning flipdover, I read with amazement the amount of auto immune conditions there are out there. Some have been around or at least recognised for many years, PMR, Ms, whilst others are are only just being given names although they could or probably have been around for years too.
i definitely believe, although I have no evidence, that our environment, lifestyles etc play apart in whether we develop these conditions. I think that our gene makeup plays a part in all of this too.
i read an article about the children of a Manchester (I think it was Manchester) slum area in the 1940's that used to play with all the asbestos dust that would settle in the corners of their streets from the asbestos works next door. I couldn't believe the photos, the children played asbestos balls with it very much like children play snow balls. Now these children were breathing in unbelievable amounts of this most dangerous substance yet only some of the children or indeed occupants of the surrounding area went on to develop asbestosis? Why? Could it all be down to their genes? Some peoples body's are able to accept degrees of substances yet others can't? I just don't know. But take preds, luckily for me I have suffered few side effects (what it's doing to my insides Lord alone only knows) whilst others of you suffer terribly from the side effects of the drug.
i also think that here must be lots of drugs that interfere with the workings of our immune system and if we as individuals have the propensity to be affected by that, then a chain of complications then sets in that we may not suffer the consequences of for many years to come, maybe because our bodies fight it off, and fight it off until it cannot fight it any more then bang!!!
now you know of this information what do you think you'll do now regarding these injections/drug? Regards, christina
*drops jaw* Oh my goodness! Will you continue with the drug now?
That's one I will NEVER take thanks for the info....came off alendronic acid today after a discussion with my doctor yesterday... been taking it for 6 months! I went to him armed with info about the drug which I got off this site I told him everything about it and he just said "Stop taking it"! I had to bite my tongue from saying "Then why the dickens did you put me on it in the first place"! He also agreed to book me in for my DEXA scan.
thanks flipdover; unless people like you let us others know re these issues, we all blindly follow our docs and their prescriptions.....I also started a drug a few weeks ago, that my Rhuemy suggested for my Fibro,,,,and, well, (nearly used an unacceptable term.... not the f word but something still not good)......I have stopped taking it too, as it made me 10 times worse...in fact I think it did the opposite to what it was supposed to do (was bursting into tears for NO reason) Cymbalta.......just goes to show......Bron
Very interesting!! Thanks flipdover
mornin,
my Dr just offered me Cymbalta , She said she has given it to her other PT's who have PMR for energy !! I said NO ... Not another pill!
I quote from my wifes BNF.
'The British Medicines Consortium has advised (Sept 2006) that duloxetine (Cymbalta) should be restricted for use by specialist when other treatments for diabetic peripheral neuropathic pain are unsuitable or inadequate'
Had a friend who is diabetic and was given Cymbalta for neuropathy. She stopped taking it... Her reason " dry mouth".
Trade name is Prolia common name Denosumab - info at BNF page 498.
From NICE - NICE recommends denosumab as a possible treatment for preventing bone fractures in some postmenopausal women with osteoporosis (see below).
Who can have denosumab?
If you have not had a bone fracture caused by osteoporosis, you should be able to have denosumab if:
your doctor thinks you are at risk of having a fracture (see below) and
you can’t take alendronate and either risedronate or etidronate.
If you have already had a fracture, you should be able to have denosumab if you can’t take alendronate and either risedronate or etidronate.
You can ask your doctor to explain if denosumab is appropriate for you.
Who is at risk?
To see if you are at risk of fracture, your doctor takes into account your age, your bone density, whether your parents had hip fractures, whether you have rheumatoid arthritis and how much alcohol you drink a day. You might need to have a bone scan (known as DXA) to measure your bone density.
Why has NICE said this?NICE looks at how well treatments work, and also at how well they work in relation to how much they cost the NHS. NICE recommended denosumab for certain
All the "bone protection" medications have similar downsides - and Prolia/denosumab is classed as a bisphosphonate like alendronic acid. They all can cause these thigh bone fractures and osteonecrosis of the jaw after extended use.
In the UK Prolia is at the end of the list - because it is very expensive and you start with No1, alendronic acid, which is cheapest and as you fail each of them for whatever reason you move up to the next.
The marketing for AA was outstanding - bisphosphonates had been used in Pagets disease for 40 odd years and AA was the first to be launched as Fosomax for general use: "Never have a patient dying of a hip fracture again" sort of message. Doctors (being rather naive people) swallowed it hook, line and sinker and the company made a fortune on the back of it. But it hadn't been used for mass numbers before and that is when the real rate of side effects is found.
This is a bit OTT - just like the marketing - but there should be concerns about the blanket use of these things "just in case" which is what happens now. That's why I say "Dexascan first", then you can discuss the situation.
I'm not the only person to have been on pred for a few years and have no loss of bone density. There is no REAL proof that taking this stuff (any of it) prevents hip fractures - there is no REAL correlation between low bone density and fractures. People with normal bone density have fractures, people with low density don't have fractures.
However - Nefret on here has been on Prolia for a couple of years and had no problems at all. Some people have been on AA with no problems. It's like everything else - maybe it was the final straw that broke the camel's back.
As for using Cymbalta for "energy" - well that's a new one on me!!!!!
Hi flipdover, Yes Prolia does affect the immune system but so do many other meds. that are commonly used (MTX for arthritis, Pred., asthma inhalers, chemotherapy etc.). My Rheumatologist did not advise Prolia precisely because of this effect. But then she put me on another agent that has even more serious possible side-effects than this - but for a short period. . . It's all about risk-balancing. We all know people who won't fly when they hear of planes crashing but statistically flying is hugely more safe than the drive to the airport - which we don't worry about at all.. Still planes DO crash, albeit rarely. It's the same with various treatments - some have nasty (hopefully rare) side-effects but your bone disease, untreated, also does. It's all about risk. SO - read up about the various drugs, talk openly with your Rheumatologist, spend time thinking, decide what you feel is best for yourself, and then plough on and hope that, if you do experience any nasty side-effects, - that they are reversible. Best wishes.
I am presuming that you have OP diagnosed by scan . . .
It is my opinion the more medications ingested the more
problems we have. The body is a wonderful instrument
and it will do it's very best - sometimes with a little help,
in the case of PMR prednisone is the only drug I know of
that helps. After two and half years I am down to 4mgs.
just can't seem to get lower, but am holding my own until
my body tells me to try 3mgs. I am sometimes a little stiff
and tired but at 87 I feel blessed. Use common sense and
listen to your body, if you're tired rest, if your stiff go for a
short walk or just stretch - no fretting which only makes
things worse. My love to all.
Hello judygirl, you sound like one chilled out dude! Your advise is great. Hopefully I'll be down to 4mgs at the 21/2 mark but if I'm not, never mind. I am happy that you are recovering well. All the best, christina
Hi Eileen, I'm interested in your comment that "there is no real correlation between low bone density and fractures". Before I started treatment my FRAX assesment showed that I had a ' 52% chance of a major osteoporotic fracture in the next 10 years' - which freaked me out more than a little. I am aware that people with normal bone density fracture all the tjme and others with low bone density can fall and have no problems but. . .but ... with my results (spinal very low bone density) I was wondering just what was holding me upright at all !! And for how long? So then came the evaluation of research papers (not funded by drug companies), the sleepless nights - and finally the jump into the unknown . . . Kind wishes.
Judygirl, I so agree with you. The body is a wonder- and wonderful ... I believe we sometimes get in the way...
best. Judy
Here's the rub - I'm only 51, have great bone density and I have no need for Prolia!!
I'm really quite upset to be honest. I'll be doing some more research.
It's too late to reverse what ever triggered my PMR but I need to educate myself more about medications.
(Elieen, any push in the right direction welcome!)
Absolutely not! I'll also take my research (once complete!) to my Dr - she's pretty open to discussion.
I note there's no mention of side effects.....