High dose of Fumaderm

[Closed account 1259]

My 76 year old husband has been on Fumaderm since the Summer, building up the dose to 120 x 2 x 3 which is a total dose of 720. In fairness, his psoriasis is now under control. But he does have other serious health issues. He is very anaemic and has just been started on iron pills which do seem to be causing digestion problems. He was put on this high dose late September and I sort of assumed we would get an appointment with the consultant, and providing it was under control, start weaning him down to keep him on the lowest possible dose that would control the condition. (I have no medical knowledge but this is what we do with cats when we are trying to give 'quality of life' with potentially potent drugs if used long term,  such as steroids and metacam)
My question is how dangerous is Fumaderm long term at such a high dose? As anyone else been on this dose long term? He also had a very bad cough and we phoned 111 - our surgery closed for staff training. The doctor phoned him back sent him to A and E saying that the Fumaderm could have caused a drop in the white blood cells and he needed a blood test within 2 hours. He went and 9 hours later was discharged as ok.
He is having blood tests twice monthly.
He has very little appetite and his weight is now 7st 10. He has had a endoscopy which aws clear apart from gastritis and also has had a recent colon scan - waiting results. I do know that the GP is worried about potential internal bleeding but the anaemia started way before the Fumaderm so probably is not connected.
Thanks for reading - still worried that this product is not licensed in the UK and wonder if the trials included people over 65? A lot of trials do not....
Helena

[Caroline]

My 76 year old husband has been on Fumaderm since the Summer, building up the dose to 120 x 2 x 3 which is a total dose of 720. In fairness, his psoriasis is now under control. But he does have other serious health issues. He is very anaemic and has just been started on iron pills which do seem to be causing digestion problems. He was put on this high dose late September and I sort of assumed we would get an appointment with the consultant, and providing it was under control, start weaning him down to keep him on the lowest possible dose that would control the condition. (I have no medical knowledge but this is what we do with cats when we are trying to give 'quality of life' with potentially potent drugs if used long term,  such as steroids and metacam)
My question is how dangerous is Fumaderm long term at such a high dose? As anyone else been on this dose long term? He also had a very bad cough and we phoned 111 - our surgery closed for staff training. The doctor phoned him back sent him to A and E saying that the Fumaderm could have caused a drop in the white blood cells and he needed a blood test within 2 hours. He went and 9 hours later was discharged as ok.
He is having blood tests twice monthly.
He has very little appetite and his weight is now 7st 10. He has had a endoscopy which aws clear apart from gastritis and also has had a recent colon scan - waiting results. I do know that the GP is worried about potential internal bleeding but the anaemia started way before the Fumaderm so probably is not connected.
Thanks for reading - still worried that this product is not licensed in the UK and wonder if the trials included people over 65? A lot of trials do not....
Helena

Hello Helena,

On the one side good to hear that your husbands psoriasis is under control, on the other side it is very odd that he is so powerless.

As far as I know the product is licensed in the UK. The fact that a product is possibly not licensed says nothing about the safety or security of a product. Fumaderm is already in use in Germany for at leastt 30 years with very good results. That means that there are long term positive and real life results far outreaching other current medications like the biologicals as they are not yet that old.
Basically if your husband has good blood values, and he has, there is nothing against continuing the use. Blood tests twice monthly is excellent. Fumaderm can cause a drop in the white blood cells, but if you build up slowly it most cases this drop will be minimal. The trick is in the slow build up.

There is one "BUT" to Fumaderm. It is a combination preparate, it contains a combination of salts (for protection of the stomach), monoethylfumarate and dimethylfumarate. That is why there is a maximum dose which your husband currently has. Unfortunately the only working substance is the Dimethylfumarate.
The monoethylfumarate is totally obsolete and there are signals that it is not good for your kidneys.
Maybe you should have your husbands kidneys extra researched. The creatinine level of the kidneys should at least be on a normal level.

On your question if you can use this for long... well yes, myself I am already more than 10 years on a Dutch equivalent which contains only the DMF (not the MEF), and I am doing very well. From a patients community over here I know that lots of people over here even use higher doses than your husband, that is possible with my kind of DMF, and that for many years.
I use the same dose as your husband does and feeling very good. There of course are two differences, I am a lot younger and my meds are slightly different. You could perhaps think of trying, though it will not fall under the NHS.

Caroline

[jiml]

My 76 year old husband has been on Fumaderm since the Summer, building up the dose to 120 x 2 x 3 which is a total dose of 720. In fairness, his psoriasis is now under control. But he does have other serious health issues. He is very anaemic and has just been started on iron pills which do seem to be causing digestion problems. He was put on this high dose late September and I sort of assumed we would get an appointment with the consultant, and providing it was under control, start weaning him down to keep him on the lowest possible dose that would control the condition. (I have no medical knowledge but this is what we do with cats when we are trying to give 'quality of life' with potentially potent drugs if used long term,  such as steroids and metacam)
My question is how dangerous is Fumaderm long term at such a high dose? As anyone else been on this dose long term? He also had a very bad cough and we phoned 111 - our surgery closed for staff training. The doctor phoned him back sent him to A and E saying that the Fumaderm could have caused a drop in the white blood cells and he needed a blood test within 2 hours. He went and 9 hours later was discharged as ok.
He is having blood tests twice monthly.
He has very little appetite and his weight is now 7st 10. He has had a endoscopy which aws clear apart from gastritis and also has had a recent colon scan - waiting results. I do know that the GP is worried about potential internal bleeding but the anaemia started way before the Fumaderm so probably is not connected.
Thanks for reading - still worried that this product is not licensed in the UK and wonder if the trials included people over 65? A lot of trials do not....
Helena

Hi again Helena and thank you for returning, I'm glad you have so I can reassure you that the Fumaderm tablets your husband Eric is on are very safe . The only time I would be worried is if the hospital wasn't monitoring my blood. As long as they are doing that and the levels are all within the normal range I would be happy.
The dose of 720mg a day is normal on the build up phase of Fumaderm, I believe he only started on the initial tablets in August so the build up has been normal, and you then stay on the high dose for a while before, reducing to a maintenance dose ( for me that's 480mg a day less than that and my psoriasis comes back)

I don't think the weight loss can be attributed to Fumaderm ( how I wish it had that effect)  I'm 68 years old and have been on Fumaderm for four years, and hope to stay on it until it stops working. So age shouldn't be a problem.
I wouldn't worry about the drug because it's not licensed in this country, here is a link  to read
Fumaderm leaflet

Cut and paste this link it is an NHS document which may be of interest

NO LINKS ALLOWED

[Bill]

Hi,

You would need to find the cause of the anaemia. Speaking from my own experience, I would not like taking the drug with a chronic gastritis. Has atrophic gastritis been ruled out?

I hope you can get some answers soon.

Bill

[Closed account 1259]

Thanks everyone. Not really sure what is causing the anaemia Bill. But the haemoglobin should be 135 and his is 97 and has been for a couple of months. He is now on high iron pills but had to come off those before the colon scan on Monday. I think when we see the Dermo I will ask if we can start to reduce the dose of Fumaderm. In fairness, it is hard to get him to take the 6 tablets a day so often he only takes 4 and I find the other 2 in the pill organizer. I do agree that for most Fumaderm would appear to be safe for long term use, but with Eric and his co -morbidities, I am not convinced! But psoriasis is pretty horrible too so I guess all we can do is try to work out the lowest dose possible to control it and go with that! Hopefully we will get an appointment with the dermo in December. He has recently got a Geriatric Consultant who appears to be very good and is trying to get the Dermo, GP and consultant who did the endoscopy to work out a plan together - basically to make sure that nothing is being prescribed that could potentially interact dangerously with what else he is taking. but it feels like one step forward and 2 back and today he is just over 7st 8 - he used to be 10st 10 in early Summer so that is a very dramatic weight loss. The acid reflux pills can cause internal bleeding too....GP very good thankfully but I get feeling he too feels a little out of his depth at times. Thanks for reading - at least I feel reassured re Fumaderm.

[jiml]

Another little fact is I continued taking Fumaderm all the way through my radiotherapy for prostate cancer without any interaction. Whatever is causing his weight loss I would doubt it is his Fumaderm
And the anemia (reducition of red blood cells ) doesn't show as far as I can see as a side effect

[Closed account 1259]

Totally agree Jim and the weight loss started before he went on the tablets and was initially blamed on the ciclosporin which is known to cause lack of appetite. Also as far as I can see, Fumaderm is more likely to cause a reduction in the white blood cells but this is being monitored with the twice monthly blood tests.

[jiml]

Totally agree Jim and the weight loss started before he went on the tablets and was initially blamed on the ciclosporin which is known to cause lack of appetite. Also as far as I can see, Fumaderm is more likely to cause a reduction in the white blood cells but this is being monitored with the twice monthly blood tests.

Yes that is true it is more likely to reduce the White blood count and particularly the lymphocyte count
But you are being monitored well

[Fred]

Just to help with what you was asking when you said "still worried that this product is not licensed in the UK"

Quote:

---

Sometimes a healthcare professional may recommend an unlicensed medication or an off-label use for a medicine.

Off-label use means that the manufacturer of the medicine has not applied for a licence for it to be used to treat your condition. In other words, the medicine has not undergone clinical trials to see if it is effective and safe in treating your condition.

However, the medicine will have a licence to treat another condition and will have undergone clinical trials for this.

Many experts will use an unlicensed medication if they think the medication is likely to be effective and the benefits of treatment outweigh any associated risk.

Source: nhs.uk

The bit not mentioned in their statement that local NHS trusts will know is "In the absence of a license, a drug may still be prescribed in the UK provided there is funding available locally to pay for it and there is a clear body of evidence to confirm that the drug is effective for the condition in question and that safety concerns have been adequately addressed"  

As your husband is being prescribed Fumaderm and not buying it privately there is no problem. They are and will keep a check on him, so don't worry that it's not licensed as such that mostly means that you can't legally buy it on the open market. But a registered professional such as your dermatologist can prescribe it provided it is funded locally.

Just think yourself lucky you are in a good part of the UK and getting the treatment you deserve, some can't and probably won't get Fumaderm.    

Hope that helps clarify why you are seeing it as unlicensed in the UK.

[Bill]

That is a big weight loss. What treatments have been tried other than iron tablets? Vitamin B injections? Antibiotics?