Every few weeks I check in with Amgen -- the manufacturer of Prolia -- to tell them how I'm doing.
I'm sure they are concerned so I want to let them know!
I use the number they give for this purpose: 800-772-6436 which is staffed by nurses and pharmacists.
They record calls (which is what I want them to do) and they often say they will report this to their "safety" division, but they don't give advice. They just tell you to "ask your doctor" and in my case that's turned out to be something of a blind alley in terms of getting the information I most need!
However I continue to call Amgen on a fairly regular schedule, especially since their lawyer called me (as noted elsewhere on these pages) and told me not to do so. Recently my goal was to let them know that while I can now actually stand or sit for an hour now without too much pain, much more than that is still painful. In the interest of keeping what happened to me from happening to others I want to make it very clear that I think the word "delay" belongs on their warnings about Prolia.
They do mention in their professional labeling that "stopping" Prolia can result in vertebral fractures, but nowhere could I find the word "delay."
They warn not to stop (or discontinue) Prolia without informing their health care advisor. But in my case, this drug was delayed BECAUSE of my health care provider!
And never once in the time before that had I considered "stopping" the drug.
When I have shared this with the Amgen phone personnel I have never gotten a good answer.
I have tried to explain that for most speakers of the English language the words "stopping" or "discontinuing" connote both intentionality and permanency. ("Have you stopped smoking?" Most people who say they have stopped smoking do not INTEND to start again. True, they might smoke in the future, but this was generally NOT their intent when they STOPPED.)
I would say that whatever special connotation the words "stop" or "discontinue" might have for doctors, for most patients these words used in connection with a regular activity imply termination, not delay, of an action.
I never intended to STOP Prolia. Although I had some problems with it (the back pain, the itching skin, the issues getting needed dental work done) it appeared to be of some value in slowing bone loss, at least as reflected in DEXA scores (although this may not be such a great indicator as I'm coming to learn).
My Prolia injection scheduled for late January 2018, was delayed as noted before because of a change in medical personnel at the U. of C. and no one there seemed to have the time or inclination to take a minute to give me a call and say "Hey, Joan, even though you don't have a doctor here right now, come on in at the scheduled time for your Prolia shot, because even a short delay could leave you with broken bones and lengthy or even permanent pain and disability!"
Instead I was simply informed at that my doctor had left, that my late January appointment was cancelled and the new doctor would not be able to see me until late in May. And sometime in early March my bones broke in a painful collapse!
So you can imagine the urgency when, after asking several times earlier and getting no definitive answer, I finally asked the people at the Amgen phone number (800-772-6436) several times until I got a YES for this specific request: "Will you tell your "safety team" that you received a specific request that the word 'delay' be included in labeling." I had to ask this representative three times before she finally said that she would do this.
I asked her who was on their "safety team" and she said she was not authorized to give that information. I'd like to reach them and if anyone has ideas about this let me know! I'd like to know what they are doing about this important safety matter!