Leflunomide side effect?

[AdoptMeow]

I've been taking 10 mg of leflunomide daily for two months. The bottoms of my feet feel swollen and sore. Is this the beginning of peripheral neuropathy? My doctor recommended doubling the dose, which I declined. She didn't answer the question about neuropathy risk.

[Ruadh]

Your rheumatologist was remiss in not addressing your question. Yes. Leflunomide does indeed cause neuropathy. Patients have to be carefully monitored. This drug can also cause damage to the liver; liver toxicity... A patient group has approached the FDA to ask for it to be removed from the marketplace. Please check out the following research criteria : ........< Leflunomide risk of neuropathy >...... and follow up the various links. Then I would respectfully suggest you follow this up with your rheumatologist. 'Careful monitoring of the patient's neurological status during leflunomide treatment is mandatory.'Some rheumatoid arthritis patients may develop mild form of neuropathy, but leflunomide drug can indeed lead to horrible neuropathy and other UNwanted side effects.

'Leflunomide may cause peripheral neuropathy, and presenting symptoms may mimic rheumatoid vasculitis'. In addition, has been known to 'induce cystoid macula oedema'.

Suggest you seriously discuss your findings with your rheumatologist. Bonne courage.

[AdoptMeow in reply to Ruadh]

Thank you for your comments. I just noticed last evening that my hands and wrists are also somewhat swollen and sore. The rheumatologist doesn't agree that I have PMR, so she is treating inflammatory arthritis. But I'm sure my PMR diagnosis in June 2018 was correct, and it wasn't challenged by the three rheumatologists who saw me before this one. Since PMR is a vasculitis, I sure don't want to take a drug that can also cause vasculitis. She also never discussed with me the fact that leflunomide stays in the body for two years.

[Ruadh in reply to AdoptMeow]

Oh AdoptMeow - Just too darn stressful. And it 'stays in the body for two years'...! Good you are getting referred to the hospital. Make notes for yourself, and a copy for the specialist team you will be seeing. So easy to forget to note summat or the other. A little history and what has happened, and, where you are with it all now. Good you are determined - and continued courage. Big (((HUG))) from over the watery divide. Bonne courage.

[PMRpro Ambassador in reply to AdoptMeow]

It only rarely remains in the body for 2 years - its half life is 2-4 weeks, a substance is completely out of the body (or not measurable) in about 5 half lives, so 6 months at most. There are always outliers. If it must be removed from the body quickly there is a wash-out procedure that can be used.

Drug induced neuropathy usually goes away when the substance is stopped - so vigilance is required. If a doctor won't listen - go to another,

[123-go]

I agree with Ruadh in that your doctor should have addressed your question. It is entirely possible that he/she doesn't know, in which case he/she should have looked it up. One of the side effects of lef is, indeed, neuropathy and your doctor has been remiss in ignoring your concerns.

The article Ruadh mentions appears to have been written in 2008. There has been much research carried out on Leflunomide since and it is my understanding that it is only prescribed when the benefits outweigh the risks, serious side effects being rare. However, there are some adverse effects when taken with other drugs and you should look into this if you are taking other medications.

You should also be having monthly blood tests to check your liver function in particular and you should avoid alcohol.

I should mention here that I've been taking 10mg lef daily for 5 months and have had no apparent side effects. Whether your sore, swollen feet are an indication of peripheral neuropathy is not for me to say, but it is something that needs looking into as should any new symptoms. If I were you and my doctor wouldn't investigate, I would find someone who will.

[AdoptMeow in reply to 123-go]

Since the rheumatologist and I don't agree when I tell her I'm certain I have PMR ("it goes away by itself within two years"), she has referred me to the University of Virginia or Duke U Hospitals. Hope to get clarification about vasculitis and why leflunomide is considered beneficial in spite of the neuropathy risk. I'm going to stop taking it until then.

[123-go in reply to AdoptMeow]

Hi. The alert for your reply has only just appeared and I see that you commented 20 hours ago. We all know that PMR doesn't go away on its own! You must feel as though you are hitting your head against a brick wall. I hope you get the clarification you need. Those of us taking Leflunomide will most certainly be interested to hear the response from the hospital. Good luck.

[Helipad]

I am on Leflunomide as well, at 1 point i was taking 20mg a day, along with Pred and Tocilizumab, and I have developed peripheral neuropathy. The bottom of my feet feel like I’m permanently walking on a scrunched inner sole, I also get burning sensations, tingling, numbness, the full works. My rheumatologist has shown no interest in these symptoms whatsoever but luckily for me my GP has but I expect whilst I’m on this medication nothing can be done. I tried talking to my Rheumatologist about symptoms and he just got irate and basically his way is the only way.

[PMRpro Ambassador in reply to Helipad]

If that is neuropathy I think your rheumatologist is being negligent and I'd be hi-tailing it out of his way. I would NOT accept any doctor who was that narrow-minded and abandoning MY body to unnecessary damage. And since I know who you see - not even him. Especially since this is one sided - he has changed approaches in a way that suggests he is trying out different ideas on patients by doing so.

One lady I know in the Scottish charity did brilliantly with leflunomide in terms of getting off pred - but at 20mg developed neuropathy so stopped with an immediate return of symptoms and needing to start over again with pred. She experimented with 10mg - no neuropathy but not quite enough so went up to 15mg which worked OK until suddenly she had a flare of PMR symptoms that also sent her back to 20mg pred.

I would maybe consider trying it. Methotrexate didn't suit at all but I'm scared of leflunomide. I am a sole carer, I have enough dealing with limitations that are unlikely to change on leflunomide, pred hasn't caused identifiable problems yet. But my rheumy, as much a world name as yours, doesn't throw his toys out of the pram when I express reluctance,

[Helipad in reply to PMRpro]

Yes that is my problem and he basically told me last time if I don’t do as he says he will stop my Tocilizumab injections and it’s very difficult when my next appointment is probably at least another 6 weeks away, they haven’t given me a date yet and I did used to get a telephone call from one of the nurses mid way between appointments but I’ve heard nothing about that either and as I’ve been told not to ring the department leaves me a bit in limbo. I intend to talk to my GP about it all as she is really good and said if need be she will contact Rheumatology on my behalf. I have to say I was expecting such good things when I found out who my consultant was, after reading about all the work he had done but have been left really let down and alone.

[PMRpro Ambassador in reply to Helipad]

To be honest - whoever it is, if a consultant threatened me like that I would put in a complaint. Do you have an inflammatory arthritis? The trials for TCZ and GCA did not include a DMARD as far as I know although they do use them alongside TCZ in RA. That is the sort of thing I was meaning - I don't mind being experimented on if that is made clear but otherwise ...

[Helipad in reply to PMRpro]

No I don’t have an inflammatory arthritis, not that I’m aware of any way. Originally I was diagnosed with GCA and PMR but when I actually saw him for my last appointment he said it’s not PMR but Fibromyalgia. When I mentioned the 20mg of Leflunomide I was still taking and asked if he wanted me to reduce that or even stop, he just asked me if I would like to reduce, I did point out that this was what his colleagues had originally told me would happen once they were sure the TCZ was working. He seems more interested in getting me off the steroids very quickly, I’ve gone from taking 60mg at the beginning of September, this week I’m taking 7.5/5mg on alternate days and next week it will be 5mg every day and by the end of the month he wants me on 2.5mg.

[PMRpro Ambassador in reply to Helipad]

How long have you been on pred altogether? That's a breakneck reduction for someone who's been on high dose pred for a longish time. You have had GCA and are on TCZ but it isn't PMR causing pain? How's he work that one out? And why drag in fibro all of a sudden?

[Helipad]

Only been on Pred since last September so yes it is a break neck speed and I don’t know why he’s suddenly said fibro and not PMR, though I do have a lot of the PMR symptoms but then I thought I had PMR symptoms, I have to say it’s all really confusing.

[AdoptMeow in reply to Helipad]

I can understand your confusion! If you have PMR, what is the reasoning for taking two pred sparers and suffering the side effects of both? If it is actually fibromyalgia, none of the three meds are appropriate treatment since it is not an inflammatory disease. I've had fibromyalgia , a nervous system malfunction, since 1984 and PMR, a vasculitis, since May 2018. They are very different conditions, and one cannot suddenly turn into the other.

[Helipad]

I do have GCA as well which is why I was started on Pred initially, I also have CRPS which is another chronic pain condition but yes totally agree.