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Evenity - My Email to FDA
Below is the email I sent to the FDA. If you wish to chime in, the addy is druginfo@fda.hhs.gov.
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I would like to express some concerns with an aspect of the approval process for Evenity (Amgen’s romosozumab-aqqg ). This may apply to other medications but Evenity is the one I am dealing with now. Evenity is recommended as the best medication for my osteoporosis but I am hesitant to take it for the reasons below.
It seems that all of the initial studies took weight into consideration with 3 mg/kg of body weight the maximum dosage used. Amgen then applied for approval setting the dosage as if all people weighed 150 lb. (Average weight currently for women is 170 lb.) The result is that the approved dosage is 210 mg. This one-size-fits-all approach has the dosage for me at 5.7 mg/kg. (I weigh 100 lb). No study included that high of a dosage. I was told by an Amgen representative that weight was not considered in the trials. Based on the 3 mg/kg criteria, the dosage for me should be 135 mg instead of 210. That is a HUGE difference. Why does the FDA not require consideration of weight when approving medications? Does the FDA require information on those who drop out of trials? Do those who are overmedicated drop out at a proportionally higher rate due to more severe adverse reactions? Or is that information hidden from the FDA? Which of you would like to go into surgery with the anesthesia appropriate for my weight or would you want the amount appropriate for your individual weights? I realize that not all medications can be completely individualized based on weight but at least 2 dosages could be offered.
Evenity does come in a manner that is possible to adjust in a gross manner for weight differences. Each dose comes in 2 syringes each containing 105 mg. However, health care providers are fearful of going off-label. They would prefer to poison us rather that to do what is right for the patients. Using only one of the syringes each time is reducing the dosage but not changing the actual use it is intended for. I can name some other medications that are used in what I would call a true off-label manner. Almost daily we read about Ozempic, a diabetes, medication being used for weight loss. Then there was Hydroxychloroquine, a malaria drug, used unsuccessfully for Covid-19. And Ivermectin, a drug used to treat heart worm in dogs, also tried for Covid-19. (desperate measures in desperate times.) Somehow, using a weight appropriate dosage does not seem to me to fall in the category of off-label usage.
Is there a way the FDA can help those of us with low BMI get the treatment we need in as safe a manner as possible?
Thanks in Advance for considering my request
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@normahorn
I totally support your letter.
There are certain drugs that do need to be regulated by weight for dosage.
Evenity is a fairly new product that really has not been on the market long enough to have a big database of side effects.
I unfortunately do not see the FDA regulating this.
We need the major national health organizations, doctor organizations, and the doctors themselves asking for dosage by weight before the FDA will go for this.
The one size fits all for aromatase inhibitors is in the same category.
CC your letter onward to the doctors osteoporosis organizations, and national doctor organizations and women’s osteoporosis groups.
That way, it might be heard and at least make some individual doctors think about this.
Also, present these facts to the doctor who is prescribing this to you and get a 2nd opinion doctor input if necessary..
Post again when you get any feedback back from anyone.
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7 ReactionsI believe FDA is supposed to reply within 5 business days. I will share that response with the forum.
As to other organizations, please feel free to contact them. The more of us speaking up, the better the chance to get what we need. Permission granted to use all or parts of my email.
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7 ReactionsI have been communicating with my doctors on this, as well as MedWatch and Amgen. Great job in the letter.
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5 Reactions@normahorn
Posted in Med Page.
“Through a program called Project Optimus, the FDA is pushing drugmakers to include more patients in early dose-finding trials to get better data on when lower doses can work. A key motivation for the project was "the growing calls from patients and advocates that cancer drugs be more tolerable," said FDA spokesperson Chanapa Tantibanchachai in an email.”
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1 ReactionThank you so much for addressing this with the FDA, I look forward to the response. My doctor strongly recommends Evenity, but I am resisting. I weigh 108 and therefore i think i might be susceptible to the really bad side effects. (Years ago I had a horrendous experience with Boniva and vowed never again to use osteoporosis drugs. But I know there are newer and hopefully better ones now.) I definitely don’t want a fracture but i also don't want my life to be negatively impacted by awful side effects,
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5 ReactionsFDA's response. At least I can say I tried.
Basically, back to Amgen to correct their "error". WindyShores and I have already contacted them a few times. Any else want to try?
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Dear Norma,
Thank you for writing the Division of Drug Information in the FDA's Center for Drug Evaluation and Research.
We are sorry to learn about the problem you are experiencing in regards to the dosing for Evenity. We have forwarded your email to the appropriate FDA office for awareness.
Please understand that pharmaceutical firms, not the FDA, determine the products they want to research and develop. Pharmaceutical firms determine how they want to develop a product, conduct studies, and then submit the data to the FDA for review and approval.
Best regards,
TNC
Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
Tel: 855-543-DRUG (855-543-3784)
druginfo@fda.hhs.gov
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3 ReactionsThank you for your efforts on this matter. It seems an issue that needs FDA attention and it is discouraging to learn that the agency does not appear to see it that way. I wonder what its position is on dosage for meds given to children?
Is there no osteoporosis patient advocacy organization? I see there is something called 'Bone Health and Osteoporosis Foundation.' But a very swift review of its website is not encouraging although it offers a program call Bone Buddies that sponsors online via Zoom weekly support group meetings. The Feb agenda can be found here. https://www.bonetalk.org/articles/bone-buddies-virtual-support-group-february-2024-schedule
Anyone have any experience with this group? Seems like an effort primarily to 'raise awareness' although there looks to be a recent merging of what had been 2 different groups so perhaps this suggests a broadening 'mission,'
I wonder whether this group might be interested in Norma's email to the FDA and the FDA's response?
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3 ReactionsOOPS. Just discovered that the Bone Health and Osteoporosis Foundation, an 'advocacy' organization acknowledged 'support' from Amgen on its website.
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1 ReactionMost people do fine with the full dose. I doubt there is any incentive to change. Forteo never changed that dose either. Doctors can choose to allow us to do one syringe. Amgen directed me back to my doctor.
That said, they did follow up on my main side effect, and called me and then with my permission called my doctor in order to document it. Maybe the best way to go is to report a side effect to MedWatch. MedWatch contacted Amgen. Liability may be the best motivator.
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4 ReactionsI believe the Osteoporosis Foundation has an Inspire forum, which I didn't find to be as helpful as this one.
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3 Reactions