Methotrexate Shortage

I've had PA for about three years. My condition is bad enough that I take Methotrexate, Humira, Relafen, and folic acid. This combination has worked really effectively.

Now I find out that there is a methotrexate shortage and that this drug will not be available until maybe November.

Am I the only one worried about this situation? Is any one else out there affected by this shortage?

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You take MTX injection, right? As far as I know there is no shortage on MTX pills.
Can you switch to pills?

You can monitor some company shortages and maybe get some additional information on the FDA website:
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314741.htm

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No. I take pills. A family member takes MTX pills for Stills disease. Neither of us can get MTX. And, my pharmacist told me last week that he had nine other customers waiting for pills.

I did notice that there is no mention of a shortage of MTX pills on the internet. Also, I could find no mention of an MTX pill shortage on the FDA site, only a shortage of MTX injections.

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That's odd, there doesn't appear to be a shortage where I live. Just got a refill this weekend too.
I do know that different pharmacies might use different wholesalers which represent various manufacturers. Maybe try a different pharmacy?

Wish you luck.

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I agree that taking methotrexate once daily will improve psoriasis as i've experienced..but be aware of the result of taking too much of this med..it will affect your liver, so let your dermatologist monitor your psoriasis, visit them regularly for check up.

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Roberto, I hope that's a typo - taking methotrexate DAILY can be fatal. It is taken once a week for psoriasis.

It is sometimes prescribed daily for certain indications but only for a short period of time.

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I phone in a refill for my methotrexate last week (pill form) and was told that they did not have any and have no clue as to when they would be getting any. What a scary thing for all of us who depend on this medication to help with our autoimmune diseases and to slow the progression of it. I wish all of you luck in getting some from your pharmacy if they still have any.
Taffy

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Well. I have finally figured out my methotrexate shortage problem.

I have been getting my prescriptions from Walmart. For some unknown reason, Walmart recently ran out of methotrexate and cannot, at this time, replenish its stock. From what I've heard this morning, there is at least one other pharmacy in my area that cannot replenish its supply of methotrexate.

Next question. Are drug shortages going to be an on-going problem for the foreseeable future?

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Oh. I forgot to mention that I got my monthly supply of methotrexate this afternoon from Walgreen's.

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I had to go to a different Rite Aid store to get mine as well.

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i got a 3 month refill of methotrexate from my cvs--the pharmasist told me he did not hear of any shortage of it. when there is talk of a shortage of anything thats just an excuse to raise the price. back in the 70's there was supposed to be an oil shortage. well we know there isnt. so when i hear there is a shortage of things i don't believe it.

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I also had to wait a week to get my refill of the pills. But i eventually got them, and my rite aid said they had to find another manufacturer that had them.

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Thanks TW for the suggestion of trying another pharmacy. That's exactly what I did and I got my refill.
Sincerely, Taffy

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Be very careful. If you're like me, the type of Mx pills with NO preservative that I take weekly control my PsA in my hands well - the ones I take are made by Teva and are football shaped and yellow (2.5mg each pill in those I take; don't know if all dosages are the same shape and color).

There isn't a present shortage for Mx made by some other manufacturers 'but' it all has preservatives in it, and may either do nothing for your PsA, or hurt you. Don't remember the manufacturer of the preservative type I got that once (traded them back to the druggist for my regular type) but they're round and yellow, the yellow being about the same shade as the football-shaped Teva type. Normally by the end of the week with the Teva non-preservative type my fingertips and fingernails are starting to hurt again and the skin around the nails on my little fingers looking inflamed again. Taking my weekly Teva non-preservative Mx dose makes all that disappear by the next day. With the preservative type, the symptoms just got worse and worse.

My druggist found a couple of bottles 'somewhere' in a warehouse of the football-shaped non-preservative type and has reserved it for me so I'll have enough to last another 3/4 of a year, as I fill prescriptions (this 'shortage' started for me Spring, 2012). What scares me, though, is that he mentioned to my husband last time he picked up a prescription that maybe I should consider biologics - which won't happen for 2 reasons: 1) the sometimes terrible and deadly side effects and time limits you should take them scare me much worse than low dose weekly Mx's possible effects on my liver (no effect yet over about an 8 year period), and 2) they aren't covered by Medicare or my supplemental Rx drug plan, which I'm sure the druggist knows, and no way I could afford $30-40K out of pocket 'if' I was willing to take them. Husband didn't know 'why' the druggist mentioned them but first time it has happened - I'm afraid the druggist was hinting there will be a continuing shortage of non-preservative type Mx.

It's a profit thing causing the shortage; Mx is no longer patented but the patent holder still controls which secondary manufacturers can make it and how much - and that type Mx isn't bringing in as much $ as it did while it was under patent. Hard to believe the drug companies would short hospitals and let kids with leukemia die because of profit, but that's it.

The article doesn't mention it is also used to control PsA; just rheumatoid arthritis. Perhaps because more RA around than PsA? Probably it is more expensive to make the non-preservative type since it wouldn't last as long and probably can't be made in as large batches - and they can't charge as much since the patent ran out.

The Mx type with preservatives can't be used for kids with leukemia (injectable type) - kills them. Evidently both injectable and pills with preservatives can't be used for many things since the hospitals are so frantic about being able to find it, too. So I assume this article from Life Extension Foundation (lef.org) about the upcoming trials using Mx for other diseases and risk factors will place yet greater pressure on us, the kids with leukemia and the hospitals being able to obtain Mx without preservatives since they do mention leukemia in it - though maybe quantity demand will make it profitable enough for the drug companies they'll start letting the non-preservative type be made in larger quantities again:

"Tuesday, September 11, 2012. An international multi-site trial has launched to determine whether a common anti-inflammatory drug can reduce heart attacks, strokes, and deaths due to cardiovascular disease in people at high risk for them. This study is being supported by the National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health (see also Diabetes).

Inflammation, along with high blood pressure and high cholesterol, plays a major role in heart attack and stroke. The Cardiovascular Inflammation Reduction Trial (CIRT) will determine whether treatment with a drug specifically targeting inflammation reduces rates of cardiovascular events among adults who have had a heart attack within the past five years and who also have type 2 diabetes or metabolic syndrome. The trial will randomly assign participants to receive methotrexate given at 10 to 20 milligrams weekly for three to four years or a placebo. Methotrexate is an inexpensive generic drug commonly used at low doses to treat rheumatoid arthritis. It is also used at higher doses to treat certain forms of cancers such as leukemias and lymphomas."

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how do know if they are preservative free? I used to have the football shaped ones...Ive noticed i now have round yellow ones made by DAVA Pharmaseutical.

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After the fact (of trying both) both my doctor and my pharmacist told me about the difference - preservative free (or non-preservative) vs. with preservative. Plus it was mentioned in data sent to me by fda.gov right around the same time (early spring, 2012).

You can sign up on the FDA site to be notified by email about drug shortages, recalls (drugs and foods - be forewarned the food recalls will make you wish you really could grow all your own food - scary what's in our food chain now), and you can also search Methotrexate as a drug on fda.gov and see what they say about the 2 different types. Search Methotrexate shortages there too while you're at it - since they've sent me email notices about them (ongoing; still occasionally get an email on that topic) I can't imagine that data isn't still in their database of info about specific drugs.

Didn't know there were different types myself till I got a bottle of the round pills - when I asked because I thought maybe I'd accidentally been given a wrong drug, (I'd never seen the round pills before) was told then just a different manufacturer. After experiencing the difference in symptom control I again asked both doc and druggist and was 'then' told about the preservative vs. non-preservative types - and druggist felt sorry for me, I guess (small town) and hunted till he found some of the non-preservative type to stock for me. 'Then' I started getting the FDA notices re hospitals not being able to get stocks of Mx for their patients, and some kids with leukemia dying (or being paralyzed - had forgotten that happened, too) after being injected with the preservative type. So I started googling and found much more data about why this was happening. A lot of the links are about injectable Mx, but you'll find some on the pill form, too.

I just searched on Google using "preservative vs. non-preservative Methotrexate" and "Methotrexate shortage" and "Methotrexate with no preservative" and "preservative free Methotrexate" and got lots of results for all of them (particularly a bunch back in Feb. 2012). Companies called Bedford and APP were given FDA approval to manufacture some back then to try to supply hospitals and the kids with leukemia; don't know if they're still making it as I'm lucky enough for a while yet to still be getting the Teva football pills I've always taken.

Or start with searching fda.gov, drugs.com, nih.gov - any number of good sites out there that will give you more info. I expect you know we all get different search results now on Google, based on what we've searched for in the past? 'If' you get the same results I did, go down the page a bit and look at the ABC News link for Feb. 10, 2012 where they're talking about the shortage of preservative free Mx for kids with leukemia (didn't click on through to the article but what I could see at the link was that it is considered less toxic - this is for injection into their spines, mind, so not pills in that case).

There are probably threads about it here on Inspire, too - I just don't know how to search to find them but one of the others contributing to this thread may well be able to help you find those threads.

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I really don't think that the pills have a preservative free version...by definition of them being in solid form and not needing to be preserved like that, they can just be coated. Someone must be getting the info mixed-up.

My understanding has always been that the liquid form MTX intended for low dose injection has the preservative Benzyl Alcohol (I believe) and a preservative free version is offered for high dose injections and certain indications. Besides, the only 'preservative free' forms of MTX approved on the FDA website are all injectable (liquid).

I think you're right about shortages being driven by profits though - it's relatively easy for a pharmaceutical company to get into generics so there's competition and it's a volume game. But vials are difficult and can be expensive to process so I can imagine that companies might want to get away from that business. As a result, more drugs are being manufactured overseas and that introduces other issues with the supply chain leading to shortages.

For example, look at the huge Indian pharmaceutical company Ranbaxy - only recently was the first time the US Department of Justice issued a Consent Decree Injunction against a foreign company for falsifying data (in ANDA applications for generics) and also for not making a lot of important drugs correctly. The US DoJ doesn't really have authority in India but it was allowed so they could continue manufacturing and supplying under the injunction....because the USA is a huge market...and we desperately need their drugs since no one here wants to make them because it's too expensive.

Then it becomes a public health issue if people can't get necessary drugs - the government can't force US companies to make certain drugs so they have to work with what they got -> a foreign company that falsifies data and takes shortcuts -> to get what is needed for treatments. But it has to be safe and Ranbaxy has a record so there's extra attention. Everything slows way down.

I think there's only 4 approved manufacturers of MTX tablets in the US - I'd be surprised if even half of them are made in the US so maybe we'll see more tablet shortages just because of the global supply trend, IMO. My last co-pay for a month worth of tablets was 3 bucks.

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