Evenity - My Email to FDA

Posted by njhornung @normahorn, Feb 7 4:21pm

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

Interested in more discussions like this? Go to the Osteoporosis & Bone Health Support Group.

In 2022, I had my first Dexa and my scores were terrible. Lumber spine -5, left neck -3.2, right neck -3.7. I took Reclast and had good results. Lumber spine -3.5 (11.2% increase!), left neck -3.1 (2.8% increase), right neck -3.5 (5.4% increase). My endocrinologist at the Mayo Clinic wanted me to go on Tymlos, but I decided to go on Reclast again for a second year and I have a Dexa scan this coming week to see if I got more improvement. This is what is weird. I was having lower back pain that never went away so I had a spine cray which luckily did not show any fractures and all was normal. It also stated significant osteopenia not osteoporosis. Just last month I had an MRI because I was still having back pain. Again the spine doctor said my spine was normal. He did find degenerative discs in my L4 and L 5 and I had a steroid shot in the joint. Huge improvement in the pain and hopefully it lasts. My question is why does neither test show osteoporosis? I will report back my results of the new decade scan by Friday.

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Neither x-ray nor MRI are good at diagnosing osteoporosis. Either might detect bone fissures and fractures. If either were suspicious for osteoporosis, you would be referred for the gold standard dxa.

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May i kindly suggest if you contact the fda again that you submit an adverse effect report. Sadly, i question whether there is anyone at the FDA prepared to process information in the manner you submitted.

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