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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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You are spot on. I weigh 98 lbs, and that is rarely taken into consideration. I wish I had asked for half dose during my treatment. I completed treatment but have decided not to take any other drugs
I didn't ask for a half dose . I just decline the second one. My doc okayed it after the fact. It is 10% effective vs 16% for both.
I hope you do a follow-up med so you don't lose your gains.
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1 ReactionAnyone up to the challenge of finding an email address for Amgen? In desperation I even tried Evenity@Amgen.com and that bounced.
I want Amgen to have written documentation of our concerns as I expressed in my email to the FDA.
Go to the website.
Product Inquiries
For product questions, to report an adverse event or safety-related issue, or to report a quality issue with a product or device.
U.S. healthcare professionals can also visit amgenmedinfo.com. Local contact information by country can be found here.
+1 800-772-6436 (800-77-AMGEN)
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1 ReactionI have searched the website and googled it. I can find a phone number but no email address that would work. I had not tried the web site for healthcare professionals since I am not one.
Just call them.
or use this
USA-MedInfo < medicalinformation@amgen.com>
they answered me on that email
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1 ReactionHere is the response by email: better to do MedWatch!
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.
If you experience an issue with the link, please ensure you are using a supported browser (Internet Explorer version 9 or 11, Chrome, or Edge). If this does not work, please right click on the link, copy the hyperlink, and paste the hyperlink into a supported browser.
24-0001844
http://amgenbioconnect.my.salesforce-sites.com
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Should you have additional questions please feel free to contact us by telephone at 800-772-6436. This information has been provided to you in response to your request. Please contact us via phone or at MedInfo@amgen.com, if you did not request this information.
Thank you,
Amgen Medical Information
I was able to forward a copy of my letter to the FDA using the medinfo site. Putting things in writing adds an additional layer of liability as there is documentation that they were informed.
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2 Reactions@normahorn
Excellent, hope you get a response!
Additional response from the FDA. They take our questions seriously.
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Dear Norma,
Thank you for your follow-up email.
The Review Division, who received your email, provided the information below:
Please note that drug exposure changes due to weight is always part of the FDA review. For the romosozumab trials, patients weighing 100 lbs and less were included in the trials, so we did review the safety of the drug in that population.
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