IV iron FDA approved?

[grandpianoman]

Are Iron IVs FDA approved? My doctor hesitant to recommend for me because of not knowing.

[Hidden]

You mean your doctor doesn't know?

[grandpianoman in reply to Hidden]

No. He hadn't had time to research it; promised to do so, was leery of recommending IV iron due to pubmed articles re dangers, but I pointed out that info is often outdated and more recent iron formulations are safer. I really want to try, after 50 years of this, so need info to encourage him to work with me on this.

[Hidden in reply to grandpianoman]

I suspect the reason for being leery isn't just a matter of approval. Here in the UK it would be a matter of a couple of minutes to find out if something is "licensed" or not. I would imagine it's the same in the US.

Also I can't imagine that there isn't some IV iron infusion product that isn't approved. As Graham says they may be approved for iron deficiency anaemia, but probably won't be for RLS.

However, if the rules are the same in the US as they are here, then medications licensed for one thing can be prescribed for another "off label".

E.g. gabapentin is licensed here for seizures and nerve pain, NOT RLS. It can be prescribed for RLS, off label, because it IS licensed - for sonething.

If your doctor is your Primary Care Practitioner, (PCP), then I believe this is similar to the UK. General Practitioner (GP). No GP here is going to give IV treatment, this usually requires referral to a hospital.

If it's not common practice for a PCP then they won't be knowledgeable about IV infusions and will naturally be cautious.

Additionally there are several different IV iron preparations which could be used, some better than others.

I suggest you contact Dr Buckfuhrer about this. He will be able, I imagine, to advise the most suitable product and confirm it is FDA approved.

If you've not heard of him, he is an internationally recognised RLS expert based in California.

To contact him go to the web page linked below and click on the yellow email button.

Simply ask what is the best IV infusion preparation for RLS and if it is FDA approved. Make sure your spelling and grammar are correct and he will reply - no fee.

rlshelp.org

[Graham3196]

I would have thought that a GP would frequently prescribe an IV iron infusion for anemic patients so he must be well aware of their acceptability for anemic patients.

The question I expect he is asking is whether an IV iron infusion is approved for RLS patients.

I don't know if the FDA approves treatments for various ailments

I think the way it works in Australia is as follows:

In Australia there is a government body that approves federal government funds being used for certain treatments for certain illnesses. In this case IV is approved for anemia and so is "on the List" and almost free at a public hospital. But IV is not approved for RLS so it not on the list. This doesn't mean its prohibited, but if you and your GP agree that its a good idea then you pay for it.

If your GP is really concerned that there is something wrong with an IV then trade him or her in on a nice young GP who might be more with it. Make sure he is not trying to tell you that an IV might be good for most people but you have something amiss so an IV is not good for you

[Hidden]

Maybe this article will help Dr Early is one of the top RLS experts . hopkinsmedicine.org/neurolo...

[marsha2306 in reply to Hidden]

Good advice. Dr. Earley actually is my RLS doctor and he had me do the iron infusion there at Hopkins.

[WideBody]

I believe there are some guidelines to follow with Iron IV, have you done a morning fasted iron panel yet?. Also, have you tried iron supplements. I have had good results with liquid Ferrous Sulfate. But if your TSAT is low, I believe under 20 percent, and your Ferritin is under 50, it may be worth considering an infusion.

[marsha2306]

I had it 3 years ago at Johns Hopkins. My insurance paid for it. Look up Dr. Christopher Earley. Tell your doc to look him up too.

[Graham3196 in reply to marsha2306]

Hi Marsha

I have to ask if the IV iron infusion relieved your RLS.?

Can you remember what your ferritin was increased to?

Do you know if it remained at this level or did you need any iron supplements to keep it high?

Thanks

Graham

[marsha2306 in reply to Graham3196]

It was 70 before the transfusion. It was raised to 650. It alleviated my RLS enough that I was only taking 300 mg Gabapentin at night for almost 2 months. My ferritin stayed 400+ after a year and 200+ after 3 years but the benefit of the infusion didn’t last. I had to increase my Gabapentin.

It doesn’t work for everyone but worth trying.

[Graham3196]

Thanks Its interesting to hear about IV transfusions. Unfortunately they dont provide complete and permanent solutions for most people. Mine was no help but I dont regret giving it a try. I have heard of others with excellent results so its was a chance worth taking. Even in your case you probably thought the partial relief was worthwhile.

Have you spoken to your expert about an new infusion to see if it sticks?