Methotrexate FDA warning.

[YuliK]

FDA warnings

This drug has black box warnings. These are the most serious warnings from the Food and Drug Administration (FDA). Black box warnings alert doctors and patients about drug effects that may be dangerous.

Liver problems warning: Methotrexate can cause end-stage liver disease (fibrosis and cirrhosis). Your risk increases the longer you take this drug.

Lung problems warning: Methotrexate can cause lung lesions (sores). This effect can occur at any time during your treatment and with any dosage. Stopping treatment may not cause the lesion to go away. Call your doctor right away if you have trouble breathing, shortness of breath, chest pain, or a dry cough while taking this drug.

Lymphoma warning: Methotrexate raises your risk of malignant lymphoma (a cancer of the immune system). This risk may or may not go away when you stop taking the drug.

Skin reactions warning: Methotrexate can cause skin reactions that could be fatal (cause death). They may or may not go away when you stop taking the drug. If you have certain symptoms while taking this drug, call your doctor or 911 right away. These symptoms include red, swollen, blistered, or peeling skin, rash, fever, red or irritated eyes, or sores in your mouth, throat, nose, or eyes.

Infections warning: Methotrexate can make your body less able to fight infection. People taking this drug are at increased risk of serious infections that could be life-threatening. People with an active infection should not start using methotrexate until the infection is treated.

Harmful buildup warning: Certain health problems can make your body clear this drug more slowly. This can cause the drug to build up in your body and raise your risk of side effects. If this occurs, your doctor may decrease your dose or stop your treatment. Before starting this drug, tell your doctor if you have kidney problems, ascites (fluid in your abdomen), or pleural effusion (fluid around your lungs).

Tumor lysis syndrome warning: If you have a rapidly growing tumor and take methotrexate, you’re at increased risk of tumor lysis syndrome. This condition can be fatal (cause death). Call your doctor right away if you have any symptoms of this syndrome. Symptoms include trouble passing urine, muscle weakness or cramps, upset stomach or no appetite, vomiting, loose stools, or feeling sluggish. They also include passing out, or having a fast heartbeat or a heartbeat that doesn’t feel normal.

Warning about treatments that increase side effects: Some medications and treatments can increase the side effects of methotrexate. These include radiation therapy, which raises your risk of bone or muscle damage. These also include use of nonsteroidal anti-inflammatory drugs (NSAIDs). These medications raise your risk of problems with your stomach, bowel, or bone marrow. These problems can be fatal (cause death). Examples of NSAIDs include ibuprofen and naproxen.

Pregnancy warning: Methotrexate can seriously harm or end a pregnancy. If you have psoriasis or rheumatoid arthritis and are pregnant, don’t use methotrexate at all. If you get pregnant while taking this drug, call your doctor right away. This drug can also affect sperm. Both men and women should use effective birth control during treatment.

Gastrointestinal tract warning: Methotrexate can cause severe diarrhea. It can also cause ulcerative stomatitis, an infectious disease of the mouth resulting in swollen, spongy gums, sores, and loose teeth. If these effects occur, your doctor may interrupt your treatment with this drug.

[YuliK]

One should be under careful supervision of either GP or Rheumatologist all the time whilst taking methotrexate..

YuliK. 76

Started 25 mg prednisone

Down to 7 mg

[Hidden in reply to YuliK]

Hi Yulik

GP’s cannot start treatment of Methotrexate, they can only issue a ‘script once initially prescribed by a Consultant.

No GP’s can issue the monthly prescription unless your Bloods have been taken & they have the results, you remain under the care of a Consultant at all times.

As in my case the hospital rang me when a blood level rose & it was stopped immediately.

I’m really not sure if this is particularly helpful to anyone on Methotrexate & it may be very worrying as we approach the weekend.

[YuliK in reply to Hidden]

Your post is extremely helpful. Methotrexate is discussed often lately. Giving the true insight to everyone's experiences can be very rewarding to many people here.

[GOOD_GRIEF in reply to Hidden]

A cautionary note:

There are no such restrictions on doctors in the US. Here, if they have a medical license to practice, they are free to prescribe as they please.

[Hidden in reply to GOOD_GRIEF]

In the U.K. Drugs are classified as Red, Amber, Green.

Red can only be prescribed by a Consultant.

Amber ie Methotrexate initially prescribed by a Consultant & a GP can issue a repeat.

Green a general prescribing Medication, no conditions.

Also, the Patient has to sign a Consent Form before starting the Methotrexate, have a Chest X-ray & Bloods before commencing, monthly blood tests, a prescription should not be issued unless there are up to date blood results to cross check & the patient has to carry a booklet with all their results & doses marked up in it.

I’m surprised that in the US the prescribing conditions are not as strict with such a Drug.

MrsN

[GOOD_GRIEF in reply to Hidden]

Nope.

No such luck. Freedom and caveat emptor, ya know? Which is why the dr that fixes your nose here can also replace your hip. Or your Family Practice Physician can treat you for cancer.

[Hidden in reply to GOOD_GRIEF]

Yikes!......

[GOOD_GRIEF in reply to Hidden]

Gotta do our research over here. No one does it for us...

[YuliK in reply to GOOD_GRIEF]

Shocking when you think about it.

That's why we see so many people after nose jobs struggling with their breathing. ( ENT plastic surgeon should do the op) not a general surgeon.

[GOOD_GRIEF in reply to YuliK]

That's why you always have to do your own research here, including on your physician, to determine whether they've been Board Certified in the specialty, and also, how many times they've been sued for malpractice.

You also have to research the track records of the hospitals and clinics for their ratings and how many times they've been sued, and for what.

As I said, caveat emptor.

[SheffieldJane in reply to GOOD_GRIEF]

For those who didn’t have to do Latin at school “ buyer beware”. I always thought the US was safer because you were litigious.

[GOOD_GRIEF in reply to SheffieldJane]

Sadly, litigation is only brought after the fact. Most people cannot afford to hire an attorney to file suit, and can only bring a case if they can find any attorney who will take their case on contingency. And they'll only take the case on contingency of there is an excellent chance of a very large settlement before trial, or jury award as the result of a trial.

And the medical community is notoriously protective of its own, so there is very little self policing in the profession.

So there it is...we're on our own.

[SheffieldJane in reply to GOOD_GRIEF]

Thanks for bringing me up to date. I watch too many movies clearly,

[SheffieldJane]

Thank you for taking the trouble to reproduce this for us. Methotrexate is currently being brandished at me. Needless to say, I would rather take my chances with Prednisalone.

For reasons of balance, members have reported taking this drug without problems. They may wish to add their views.

I was diagnosed 3 years ago with PMR only. I have reduced using the dsns method to 5.5 mgs from 20 mgs.

[YuliK in reply to SheffieldJane]

I refused to take it after my Rheumatologist offered it instead of Prednisone..she said it would help stop my fingers etc getting disfigured, from the Rheumatoid Arthritis I have too as well as the PMR ...😩

[GOOD_GRIEF in reply to YuliK]

Just so you know, MTX is the gold standard for treatment of RA, and for RA is given in much smaller doses than the doses where the black box warnings kick in. MTX is also used for treating many conditions from psoriasis to chemotherapy for certain cancers, and the doses vary widely depending on the condition.

I waved off MTX myself because my rheumy was convinced I had RA, even though I tested for RA factor in the normal range while my PMR was flaming along with ESR and CRP off the charts.

However, if you do have RA, you might want to consider MTX as treatment, because it is a disease modifying drug, unlike pred, which only treats the symptoms.

[PMRpro Ambassador in reply to YuliK]

In the case of RA it has been used widely as a DMARD (Disease Modifying Anti-Rheumatic Drug) since the early 1980s having been found in the early 1950s to have a speedy effect in RA and psoriasis. This isn't a brand new and untried drug in the rheumatology field, it has a tried and tested basis for certain disorders.

PMR is a different matter - the evidence for its use there is not as strong. But a post like this is likely to give RA patients the idea that they shouldn't be taking the mtx that is preventing their RA progressing to a degree that will disable them.

[Marijo1951 in reply to YuliK]

But why instead of pred? It's normally prescribed as a steroid saver so the patient can reduce the pred dose. I started taking it when I couldn't get below 25 mg of pred without flaring badly. So far I've had no nasty side effects and I have my blood tests every month.

[katiemills in reply to Marijo1951]

HelloMarijo1951, how long were you taking 25 mg of pred before you started taking Methotrexate? I was diagnosed in October2018 and have struggled to reduce from 30 mg - now I've just reduced from 19 to 18 mg . My rheumy wants me to start taking Methotrexate ( as long as my liver scan etc are ok) ASAP . I can't help but think this might be too soon. I get the feeling that quite a few people take several months or years to get below 10mg, but he's not happy with my slow tapering .

[Marijo1951 in reply to katiemills]

I tried twice to reduce to 25 mg and had two bad flares. The first was (I think) in October 2017, the second time was definitely just after Christmas that year and that was when I was given the MTX.

[katiemills in reply to Marijo1951]

Thank you for replying . What level of pred have you managed to reduce to ?

[Marijo1951 in reply to katiemills]

On Thursday I started on 9 mg per day after 5 months on 10 mg. I'm supposed to reduce to 8 mg after 4 weeks and to 7 mg 4 weeks after that, but I'll probably go at a slightly slower pace, i.e spend 2 weeks at 8.5 mg and 2 weeks at 7.5. I haven't had any obvious GCA or PMR symptoms, but I've been hit by the sledgehammer of deathly fatigue. I can't say if this is directly because of the reduction or not.

[katiemarymills in reply to Marijo1951]

Probably........good luck with your taper.

[SheffieldJane in reply to YuliK]

It must have been hard to obtain a PMR and an RA diagnosis. I know RA can be identified in the blood, but usually PMR is diagnosed on symptoms and response to Prednisalone, together with high inflammatory markers in most cases. Yet to the patient they can feel very similar. I would be more drawn to a difficult drug that claimed to cure me. Pred is just palliative.

[bunnymom in reply to SheffieldJane]

Glad to hear your taper is going well Jane 💐

[SheffieldJane in reply to bunnymom]

Please tell my Rheumatologist, she thinks I am slower than Molasses in June.

[bunnymom in reply to SheffieldJane]

You are ahead of me. Do Drs ever think we are low enough? I'd love to hear one say wow that was quick!

[SnazzyD]

Thanks for the above which makes it more of a mystery as to why some doctors prescribe it so readily before Pred has been given a chance as if it is not risky. However, there are those for whom it has been a life saver and many who have no problems at all. When I was a nurse in GP surgeries I saw some bad effects and a couple of deaths but they were all in those who didn’t for one reason or another have consistent frequent blood testing.

[YuliK in reply to SnazzyD]

Yes dear, I totally agree, some Doctors give us pills like they are handing out smarties.

Rather takes me back to the late 50s and 1960s .. thalidomide comes to mind.

[GOOD_GRIEF in reply to YuliK]

Neither MTX nor pred are "like thalidomide". Both have been used across the globe on tens of million of people - we're now in the third generation using both drugs - , while thalidomide was a rather new development, and had no been subjected to sufficient clinical trials.

[YuliK in reply to GOOD_GRIEF]

Yes you are correct regarding thalidomide .

[HeronNS in reply to GOOD_GRIEF]

In fact as far as I know thalidomide's use as a morning sickness drug was off label. Heard a few years ago that it is an effective treatment for some serious diseases, including forms of cancer and is still being used but of course much much more carefully.

[scats]

It hospitalised my brother twice. I'm not sure of the details but he passed out each time and knocked himself out. It was attributed to methotrexate.

[Longtimer]

Reminds me of the Zelondronic acid side affects that I read, couldn`t believe the list...terrifies me I will admit....so will have to do battle with the doctor next week....but I don`t think they realise just how much it scare us with these drugs....

[PMRpro Ambassador]

However - as I said in response to your other post with this information, much of the warning refers to use of methotrexate in chemotherapy where far higher doses are used.

No drug comes with no side effects. Do you take NSAIDs or paracetamol for a headache/toothache? They too can kill. It is all a question of balance, the advantages should outweigh the disadvantages, always.

I have tried mtx, I stopped the mtx because of side effects. I knew all the black box stuff beforehand, I was willing to try it after 14+ years of PMR and over 9 years of pred. I wasn't prepared to feel as bad as I did for several months to see if it helped.

Methotrexate will only EVER be prescribed by a consultant and a GP can only fill the original script. Patients are monitored by the use of blood tests for liver and other potential problems and in many cases have a direct contact with a specialist rheumatology nurse.

This is a useful piece of information to use as a basis for discussion with your doctor if they want to use it. But there are a lot of other considerations both for and against the use of methotrexate.

[GOOD_GRIEF in reply to PMRpro]

This is one of the times when I wish it was possible for someone to move a Reply up the string to the top.

Misinformation is so damaging, especially those who aren't likely to read through all the postings on a serious topic.

[Soraya_PMR in reply to GOOD_GRIEF]

I agree. Read the warnings on any drugs, prescribed and OTC, and you might think twice about taking any! It’s about balance, pros and cons. One may sail through without any side effects, or a drug may not be efficacious for a particular person. Discussion and a person centred approach are useful; although even that can’t predict allergy or side effects. Life is risky after all!

[dancersize]

This post certainly made me feel concerned as I have been on mtx as well as pred since Jan2019. I haven't noticed any bad side effects and have managed to taper from 6mg of pred to 5mg over the two months. I'm using the very slow taper and 1/2mg drops. My rheumy had an emergency trip away so self treating until she returns. Have had one set of blood tests at end of jan but haven't heard results. I feel OK so just going by that and advice gleaned on here. I was diagnosed with PMR July 2017 and spent six months from Aug 18 on 6mg because dropping lower caused pains and on 6 I felt fine. Now going down so that's good.

[polymy]

......and they say pred is the bad boy!! I am shocked.

[Neverending63]

I was on methotrexate for RD. Unfortunately had to stop it as my liver results started rising. I felt my best when I was on it and nothing has come close to it not even biologics. When I was on it I was monitored with monthly blood tests and when my results started to rise I got a call from consultation and had to stop it for 2 weeks. I had another blood test before restarting it. However eventually it went straight back up as soon as I started it so had to come of it completely. Personally I think if the benefit out ways the possible side effects it is worth trying. You never know you might be lucky and not get any side effects.

I know it is different when used in PMR/GCA as it is usually used to help you get off pred. In this case I would rather stay on the pred than use methotrexate. However this is just my personal opinion from experience of using it with RD.

[SheffieldJane in reply to Neverending63]

My Rheumatologist said ask any Rheumatologist, they would rather be on Methotrexate than Prednisalone! Glad it made you feel good!