URGENT! ACTION NEEDED NOW!
Many of us, not only with ME/CFS but with a variety of chronic illness, rely on vitamin B12 injections as a crucial part of our treatment plan. In this post, Vitamin B12 and ME/CFS, I write about what B12 does, how it helps, why it is essential, and the most effective forms and types to use. In that post, I explain why injections of B12 are the most effective way to get it into your bloodstream (oral types don't work as well, if at all), and why the most common type of B12 available commercially, the cyano- type, is not a good choice for most of us with chronic illness. Instead, I recommend using methyl- or hydroxy- types of B12 in most cases. My son and I both use those two types, made for us from a compounding pharmacy.
BUT NOW, INJECTABLE METHYL-B12 (also known as methylcobalamin) IS AT RISK OF NO LONGER BEING AVAILABLE IN THE UNITED STATES!
The FDA is currently considering whether or not to continue allowing methyl-B12 to be made by compounding pharmacies--and the track record is not promising. In the past two years, only 30% of the medications the FDA has reviewed in this way have been allowed to continue being sold.
What can you do?
Send a quick electronic comment to the FDA, explaining WHY methyl-B12 is important to you, how it helps you, how long you've taken it, etc.
The deadline for public comments is this week: Wednesday May 26!
Public Comment Link: https://regulations.gov/document/FDA-2021-N-0357-0001 (click the blue comment button)
There are multiple compounded medications being considered for removal at this time, so be sure you specify you are writing about methylcobalamin.
I received notice of this pending action from my own compounding pharmacy, so I am sharing that with you. I'll include the letter (with instructions) below as a photo, but you can also access and print the page here as a pdf. The link for electronic comments is in that letter.
PLEASE ACT NOW SO WE DON'T ALL LOSE OUR METHYL B12!
Here is the comment I left on the website (it only took a few minutes) - feel free to copy relevant parts describing the necessity of Methylcobalamin as part of your treatment - JUST BE SURE TO CHANGE THE PERSONAL INFORMATION (FIRST PARAGRAPH). If they see duplicate comments, they may not count them.
Re: PCAC Review of Methylcobalamin
My son, XXX and I, Suzan, (55) both have multiple chronic illness, including a complex immune disorder and multiple chronic infections. We live in Wilmington, Delaware. We have both taken methylcobalamin injections for 14 years, since 2007. We both self-inject every other day, alternating hydroxy- and methyl- types because that is what is most effective for us. We purchase our methylcobalamin from Hopewell Pharmacy, a compounding pharmacy, and it is prescribed by our physician. We both take 3.5 mg per dose (every other day). Because we get it from a compounding pharmacy, they can make up a higher concentration solution - 25 mg/ml - so that the amount (ml) that we inject is tiny. This makes the injections much more comfortable and sustainable over time.
Methylcobalamin is an absolutely essential part of our treatment program. Because of our chronic illness, our bodies do not absorb vitamins well, so supplementation is often necessary, as is the case with B12. This vitamin is essential for production of red blood cells and DNA and for the functioning of our nervous systems, as our disease is known to cause severe autonomic nervous system dysfunction. This means that the methylcobalamin injections help us with cognitive function, immune function, energy, mitochondrial function, and nervous system function, all of which are dysfunctional in our disease. In simple terms, the methylcobalamin injections give us the energy and mental clarity necessary for basic functioning and activities of daily living, even though the disease very much limits what we can do.
In addition, it is crucial for us to have access to injectable methylcobalamin, only available through compounding pharmacies. Many studies have shown the oral forms to be poorly absorbed, and I noticed a huge improvement when I switched from sublingual tablets to the injections. The type of B12 is important, as well. Most commercially available B12 - and ALL injectables commercially available - are the cyanocobalamin form of B12, which is not effective for us and can even be dangerous to us. That cyanide molecule requires glutathione in order to be converted to usuable methylcobalamin in the cells, but with our disease, our cells don't make much glutathione, so we can not efficiently convert cyanocobalamin. That's why direct supplementation with methylcobalamin injections is necessary.
We are not alone. I write a blog about chronic illness, have written a book about it, and have started several support groups for people with similar diseases, both in-person locally and online, with thousands of members. I know that many, many more patients with similar diseases rely on compounded methylcobalamin (either injections or in IVs) as an essential part of their treatment protocol. Please continue to allow methylcobalamin to be compounded.