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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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HugInterested in more discussions like this? Go to the Osteoporosis & Bone Health Support Group.
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Still no response from Amgen, not even an acknowledgement that my email was received, so I sent another email this morning. I would like company to realize that we all do not weigh 150 lbs. And then, like Rola, I have cll. I do not want to be overmedicated.
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5 ReactionsThank you for your perseverance. I feel the sane way. And while I really don’t want to sound like some kind of wacko, I am very skeptical of these drugs.
I am going to try two shots again next week. One shot is 10% effective and two shots is 16% effective as I remember. Both docs accept my taking a half dose but hope I can do two. Effectiveness goes up with the dose so maybe we small folks are at an advantage. One study said side effects are the same with all doses, or seemed to be saying that. I will report back on that after doing two shots, one shot, then two shots. Doing shots in the thigh slows absorption and my immediate reaction was much better than tummy shots.
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6 ReactionsBest wishes to you Windyshores. You are an amazing woman and such an inspiration to me.
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2 ReactionsGreat points all - I, too, have wondered about the “one-size-fits-all” approach to these meds. I lost weight (on purpose) while using Tymlos and later Evenity and script dosages by weight were not considered in any case. Tymlos was poison to me; perhaps a partial dose would’ve been as beneficial and less toxic. Thanks for your thoughts and email. Cheers!
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2 ReactionsPlease post if you get a response.
Are you ready for this? I heard from Amgen.
"Thank you for contacting Amgen Medical Information; the information you requested is available via the link below. The link will expire after 30 days. Any journal articles are provided in response to your unsolicited request and have been reproduced and offered to you under a copyright license. Any further reproduction and/or distribution of these digital documents by you may require further permission from the copyright owner."
Of course the link takes me to a blank page with the header of "list of Documents"
The response is from the sales team.
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3 ReactionsIf you report a side effect to MedWatch. Amgen will call you and ask permission to verify with your doctor.
We can decline the second shot and have a 105mg dose instead of 210.
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1 ReactionAmazing that the link from Amgen leads you to a blank page. Response from the sales team, hey? That must be the division wherein the corporation's greatest wealth of medical information can be found!!
Please let us know how Amgen responds when you bring this 'oversight' to its attention and whether you will then need some of us to write Amgen about how your request is being handled.
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1 ReactionMaybe someone else will have more luck with this link.
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http://amgenbioconnect.my.salesforce-sites.com