ARE YOU A DOCTOR? READ ABOUT ONE PATIENT'S EXPERIENCE WITH PROLIA
ARE YOU A PATIENT? THIS IS NOT INTENDED AS MEDICAL ADVICE
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
March, 8, 2019
Dear Doctor,
About a year ago I experienced vertebral compression fractures at T11, T12 and L3 associated with a delay of just a few weeks in receiving Prolia (denosumab, Amgen). Before these fractures I was “81 going on 60.” Retired, I was active with family, friends, organizations and travel. Now I am “82 going on 160,” in daily pain and limited in activity. This might have been averted had Amgenwarned of the danger of even short delays in administering its osteoporosis drug Prolia.
Now, after a year of pain, inactivity, physical therapy, and much out-of-pocket expense, I am slowly regaining more mobility with somewhat less pain. But some pain, disability and other problems may be permanent and they have already, directly and indirectly, adversely affect my health and my quality of life.
MY BIGGEST MISTAKE: I should never have agreed to Prolia when it had not been on the market for at least five years after FDA approval, and before many problems, including those resulting from delay (or “stopping” or “discontinuation,” to use Amgen’s language), had become apparent.
Prolia was marginally helpful, but other approaches might have been safer. And worse, despite the problems with this drug, there seems to be no way to stop Prolia safely (and without moving to yet another drug with other serious problems).
Fractures were the worst but not the only problems associated with Prolia. Problems involving needed dental care, urinary tract infections, skin problems and other matters were arguably attributable to Prolia as well.
MUCH OF THIS COULD HAVE BEEN AVOIDED. Had Amgen’s patient information specified the hazards of “delay” as opposed to a direction to “speak to your doctor before stopping Prolia,” (especially as “stopping” this drug was not my intention at the time), and had my record been flagged to have me come in for an injection on time even though a newly assigned doctor could not see me right away, these fractures and the resulting pain and disability might have been avoided.
DEAR DOCTOR, WHAT CAN YOU DO? With considerable personal effort and expense I am slowly improving, but recovery may never be complete. So to help others avoid what I have suffered, I offer these suggestions to spare your patients this nightmare:
1. Do not prescribe Prolia. If there are safer ways to treat osteoporosis and prevent fractures please consider and recommend them.
2. Report Adverse Drug Reactions arguably associated with Prolia to the FDA.
Report to Amgen as well. (800) 772-6436. You do not need to prove causation to report suspected adverse drug reactions.
3. When patients ask about Prolia (perhaps having seen Amgen’s TV ads), counsel them on the dark side of Prolia, and stress that once on it, there may be no safe way off. Warn of dangers of delay, and other issues with Prolia. Too busy? Consider the results when patients learn what I have learned so painfully, and prepare someone in your practice to counsel them.
4. For patients now on Prolia, warn about the danger of delay, as this may not be clear from the tiny Amgen tab with their next shot date. To assure this, flag patient records so staff will make sure patients are reminded to receive Prolia shots on time, and why!
5. Warn patients, as graphically as possible, that what might have been a pleasant and productive part of their lives could be abruptly, painfully, expensively and permanently terminated if they do not get their Prolia shot on time.
Patients may also find resources in this blog, including books and websites with information about osteoporosis and treatments in general.
7. Identify safe protocols to exit Prolia. Research is needed here!
8. Identify rehabilitative resources for patients injured by Prolia. If your institution cannot provide these, identify resources in your community (Medicare reimbursed where applicable).
IF YOU WORK FOR AMGEN, ask yourself: Is Prolia a blockbuster or a bonebuster?
Consider advocating for one or more of the following:
1. Withdrawing Prolia from the market or marketing it only as a last resort for osteoporosis not treatable by safer means.
2. Withdrawing television and other Direct to Consumer advertising for Prolia.
3. Developing safe exit strategies for those already trapped in a Prolia regimen.
4. Placing Black Box warnings about the danger of delay in all labeling, and highlighting warnings about “delay” (using this word) in patient information.
I regret being unable to discuss this with you in person. I am still too disabled to travel. But I hope you will consider what I have written here. No one deserves to have an active life destroyed so unnecessarily or so painfully as mine has been.
Cordially, Joan Levin, Chicago
