Confusion & Blame Surround Methotrexate Shortages & Recalls
U.S. caught off guard by methotrexate shortage
Shortages of injectable methotrexate began in 2010 and some sources say may continue through 2014. Many have been surprised that shortages of such inexpensive generic drugs could take Americans by surprise and continue for such an indefinite period. Finger-pointing at the FDA and drug companies is probably the one thing that has not been a surprise.
Over the past year we’ve heard regular reports from patients having problems obtaining injectable methotrexate. Some find alternate sources; some switch to oral methotrexate; some quit taking the drug. Only one thing has been certain throughout this crisis: confusion.
Methotrexate is a half-century old chemotherapy drug used as treatment for autoimmune diseases and several cancers. NIH is also conducting clinical trials investigating methotrexate as a treatment for certain types of cardiovascular disease.
“It’s the FDA’s fault”
According to Pharmalot, a US House of Representatives Committee on Oversight and Government Reform blames the current FDA oversight process for the drug shortage crisis. It is hard to imagine how such life saving medications could be in such short supply for such an extended period. Two FDA spokespersons I talked to were quick to say that the FDA is powerless and not to blame since they have no power to force companies to produce drugs or maintain a certain amount of any product.
In defense of FDA, factory shutdowns were ordered after some horrifying conditions were observed in some cases. To help relieve the crisis, FDA also approved imports of methotrexate from Australia earlier this year. FDA also cites lack of resources to hire enough reviewers to adequately inspect facilities and analyze new applications.
“It’s pharma’s fault”
Since methotrexate is such an inexpensive drug, many have blamed pharmaceutical companies for not producing more of it, saying there is little profit in methotrexate production compared to newer medicines. Ironically, Ben Venue Labs is owned by Boehringer Ingelheim Pharmaceuticals which makes 5 of the top 200 drugs by U.S. sales, including Spiriva, Flomax, and Combivent.
Last winter, police investigated after a ten gallon can of urine was found in a storage area of the Ohio facility. This, after mold and rust had been found previously. There’s obviously no excuse and or sympathy from the public when such lines are crossed and patients suffer needlessly.
Sorting out reasons for the methotrexate shortage
The methotrexate shortage and other drug shortage issues ca n be monitored on the FDA’s drug shortage page, you can search or scroll down to “Methotrexate Injection.” Check this page if you want to follow the shortage status of methotrexate or other drugs. Another reliable source of information is the American Society of Health-System Pharmacists. In their July Methotrexate Injection bulletin, they list reasons for the methotrexate shortage:
- APP discontinued 2mL vials of methotrexate with preservative. 10mL vials are on shortage due to increased demand.
- Ben Venue suspended all manufacturing in November 2011 on a voluntary, temporary basis. Note: Ben Venue is owned by Boehringer Ingelheim.
- Bedford has all methotrexate on hold as of July 2012 pending a new investigation of manufacturing processes. Note: Bedford Labs also owned by Boehringer Ingelheim.
- Hospira has had methotrexate shortages due to manufacturing delays. Additional note: In July 2012 Hospira recalled methotrexate and other injectable drugs due to a “glass vial defect” which could put patients at risk of injury. Hospira is the world’s largest producer of injectable drugs.
- Sandoz recalled 2mL and 10mL preservative-free vials in October 2010. Reasons not known.
- Bioiche (acquired by Mylan in 2011) does not provide a reason for shortage.
Media methotrexate mess
It’s no surprise the media has repeatedly ignored the fact that most Rheumatoid Arthritis / Rheumatoid Disease patients are prescribed methotrexate when the “cancer drug” shortage is reported. Between 1.5 and 2 million people in the U.S. have RA and most are prescribed methotrexate, a majority of those remaining on the drug a for a dozen years or more. PBS is one of dozens of examples that I’ve seen which entirely fails to mention the hundreds of thousands of Rheumatoid patients taking this drug (although not all on an injectable form).
Your report?
What have you experienced or read about the methotrexate shortage? This is an extensive, complex, and ongoing story and there is still more to report. If you have new information about obtaining of methotrexate or updates on recalls, please comment on this post so others can use as it a resource.
Recommended reading
- All RA Warrior articles on methotrexate
- What’s the Big Deal about Rheumatoid Disease?
- 3 Reasons Why the Public Image of RA Is So Rosy
- The infamous Frying Pan posts – some bottom lines in Rheum care
rawarrior I have been lucky so far, but I know soon I will have problems getting it.Pharmamist warmed me already!
No problems here in Canada that I’m aware of.
I haven’t been able to get it in PA for over 8 months now. I can’t use the oral so I’ve been suffering horribly.
Thank you, as always, Kelly for such priceless information. I have been on the MTX injectable since 2004 and now I find no other alternative but to take the oral since I’ve had so much trouble getting the injectable. Well, it just isn’t the same..I sit here, barely able to type this because I am so stiff and sore. The oral just does not give me the same relief. I am also more nauseated and the mega doses of folic acid recommended by the doctor just doesn’t take care of that usually. I am not one to be sue-happy, but for a drug company to cause so much pain and suffering, well, just who needs for the blame to be left at their feet? I am frightened that I may get to the point-of-no-return with my RA and the crippling will start…or worse, the inflammation will cause internal problems (heart, etc.)…
Thank you a thousand times a thousand for all the vigilant work you do, even in the midst of your own medical issues, to keep us all informed. You are such a blessing to us who are never sure if anyone “gets it” or is willing to champion our cause. God Bless you, Kelly! XOXOXO
thank you for taking time to type that Kathy. It means a lot to know you’re reading & it’s helping someone.
Thanks for the update. Thank goodness as RA patients we do have the option of oral MTX. It is not optimal for many of us but at least its a stop gap until injectable is available again. The cancer patients don’t have the option of oral. Injectable MTX metabolizes a greater percentage of the total dose than it does of the oral. If you find yourself with increased inflammation on the oral, you might check with your doctor about potentially increasing your dose until you can get the injectable again. Also temporarily adding prednisone or slightly increasing the dose can help you through this shortage.
I was just into the Rheumy Dr yesterday, and they said that their shortage was just lifted. I was allowed to go on the injectable Methotrexate after taking the pills for 8 months. The little glass bottles of the liquid Mtx are only a “use once” doseage, even if you use just a portion of it. So, once a week I use only half of the liquid then I am to throw the rest away – per my pharmacist. What a waste!
I have had some trouble with getting my injectable methotrexate…I have to go to a different pharmacy than I usually do to get it….the vials are made in Australia, by Hospira and are not on the list of recalled vials….I have the 2ml vials with preservative….I cannot get the ones without the preservative in it….
This is very upsetting…..my RA doctor changed me to injections and they are working…in remission…I have had a terrible year…in August of 2011 I was hit by a pickup truck while crossing a street…fractured femur w/surgery…RA went out of remission so the horrific pain of accident and surgery the RA kicked in again and the pain was beyond description…..Have been on injections for several months and it has been such a relief.
Needless this article has sent me into a tailspin….thank you for taking your time to keep us posted….
On the positive side, the shortages can get others to view RA as more serious. I have told a few people that I take that cancer medicine that’s having a shortage, and they sometimes get a shocked look on their face, like “Huh, RA must be more serious than I thought!”
Hi. I posted a few months ago about the alarming news of shortages of injectable methotrexate. The University Medical Center Rheumatology Clinic in Tucson, Arizona staff have said they understand the shortage of injectable methotrexate is because the production of the drug is not profitable. I have no facts to back-up this information. I was able to obtain the injectable form of methotrexate in Tucson and have now moved back to Canada so we’ll see.
In my previous post, I asked what the RA Foundation or RA Warrior can do as the patient advocacy groups to raise awareness of the impact of the shortage on RA patients to the FDA and other government regulatory bodies. I suggested we first gather facts, as Kelly has so brilliantly just done. Thank you Kelly for your article on this very important topic. Any suggestions for a unified approach to represent the potentially hundreds of thousands of patients taking this drug?
Hi Helen,
I do remember your post and we have been following the issue in the news and gathering information as much as possible over the past few months. I think my using the word “confusion” to begin the title to this post is significant of how things have unfolded. We watch reports on evening news implying it is all the FDA’s fault. Then, like you, we hear others blame the lack of profitability and the poor motives of the pharma industry. We visited an FDA exhibit locally and spoke with two representatives to get their perspective. So “blame” has been the other key theme.
Not solutions, a clear plan to restore mtx availability, nor any concern for the hundreds of thousands of RA patients who need it. So all along, we hear & read alarming human interest stories about how sad this is because of those cancer patients who may not get medication. Never a mention of Rheumatoid patients or that they can also be in dire straights if they cannot get this medicine.
We are doing all we can to unravel the issues and find ways to make an impact. At the same time, I have been working full time behind the scenes with the Rheumatoid Patient Foundation http://rheum4us.org. This is the only patient advocacy group specifically for RA patients in the U.S. Your question about the “RA Foundation” puzzled me because there is not one. This is why a year and a half ago we founded RPF. I probably didn’t have time to explain that when you said it the first time – I’ve talked about RPF here for the past 18 months. This has kept me so busy with also doing RA Warrior and living with RA that I myself barely have time to rest sometimes. But, back to methotrexate…
This post is the first step. I hope to learn more, write more, and take action. It is difficult to get everyone on the same page and that’s something I wish I had more time to dedicate to – but I believe that we’ll accomplish that thru RPF. Together, we can do a lot more to benefit patients. We need everyone who has been asking for such an organization to stand together with us so we can be able to work out problems like this one. Thank you so much for your confidence and I hope to hear from you more.
I missed a few doses earlier in the year but haven’t had any problem recently.
I take mtx pills and when I went to get my refill last week, the pharmacy was out of them and said they would call around to their other locations to see if they could get some. A few hours later they called me back and said someone had cancelled their prescription (without picking it up and taking it home!), so their mtx could be returned to stock and my prescription could be filled. Otherwise, who knows how long it would have taken.
Kelly, thank you for this website and ALL the work you do! I was diagnosed in April, (fortunately early), and because of you I don’t feel quite so alone and scared. You are a blessing to all of us with RAD.
My local small town pharmacy says that injectible methotrexate is still widely available BUT…the sources of the most inexpensive mtx have stopped producing it or have issued recalls for various reasons. My pharmacist says the mtx is available from other manufacturers and that most insurance companies will support those Rx if none is available from the cheapest sources. Also, my RPh says mtx is so inexpensive anyway that the cost should not be prohibitive to anyone and that if the price is jacked-up because of “shortages” that someone is being gouged. NW Georgia RAD patient
I’m in NW Georgia, too (well, more N than W). I’ve had no problems getting injectable MTX. I’ve been on it for well over a year now. It’s made my life a lot less sucky! I’ve asked my pharmacist about the shortages, and he says for now things are OK, and don’t worry about it. They are a large compounding pharmacy and carry a large inventory, so that may make a difference.
It really is shocking how many people don’t know that RAD patients take chemotherapy drugs. My hubs was in the hospital last week, and (being completely out of laundry) I one day wore my “Chemotherapy: Not just for cancer patients” with the blue ribbon and “Rheumatoid Autoimmune Disease Awareness” on it.
Being as it was a large hospital, I could not believe the comments I got (I was all over the place – waiting rooms, cafe, cafeteria, you name it) some even from RN’s. I even got the old standard “my grandma has that”.
I shake my head in shame for these ill-educated medical personnel.
Last time I went to pick up a vial of MTX at my local pharmacy, there was a small note attached that said “We’re currently out of methotrexate. We will possibly get some in late August.” The person checking me out didn’t even mention it, but I check my prescriptions right there, because I’ve been given the wrong medications many times before. I called one of the slightly farther away big-box store chain pharmacies, and basically had to plead with the local pharmacist to transfer my Rx there. The pharmacist I talked to at the big-box pharmacy said that they haven’t had any problems getting it in the last year, and are well supplied.
As much as I’m for supporting local businesses, if anyone is having trouble finding MTX in smaller pharmacies, definitely check the larger chain drug stores.
We’ve had a number of people on FB over the past few months say that only a small pharmacy could get it, so I’m wondering if there is actually a pattern or not.
If I remember correctly, the recent recall was on 40 ml vials, which is larger than the RA community would usually get. I switched to the injectable about 6 weeks ago. My usual pharmacy didn’t have and couldn’t get, but the local Pharmaca had some. My doctor’s office said that the local CVS pharmacies usually have it too. I ended up having to buy a 10 ml. vial, which the Pharmaca said the insurance wouldn’t cover because of the quantity. Say what? I would have happily taken the smaller vial if anyone could have provided it. There went about $75. It does have the preservative, though, and my doctor has said to keep using it for now.
I also have to say, I’m a little concerned about that stray 10 gallon of bucket of yellow liquid in Ohio. Is THAT where all the methotrexate actually is? Was it misidentified?
Im not actually on MTX, I’m on Enbrel and hydrochloriquinine (sp?) and a rare 5mg prednisone, which is working fairly well for me, but I’m only at 8 months on Enbrel and Doc says we may add MTX next month if I’m not better than fairly good if my liver enzymes continue to be ok.
So I ask my pharmacy regularly (and ask friends to), about supply after hearing of the shortage in a cancer help facility that I volunteer at.
So far no shortage I’ve heard about anywhere in the Boulder or Mth Metro Denver area… Doesn’t mean there isn’t, but where I ask and other have for me, we’re told no problems.
I’m analytical so I’d love to see a marked map of supply and shortage to see if there are patterns or demographics involved.
I heard that the MDA submitted something to congress related to the methotrexate problem. I believe this happened in early July. Do you know any details about this?
I have only just started MTX injections. This is because I am at the top of my pill dosage and am hoping to get the maximum benefit of the dosage via the injection and praying that this added oomph will be enough to make the difference in my needs. I could not get it at my regular pharmacy which is the most highly used pharmacy of that type in the area. They were, however, able to transfer this prescription to a lesser utilized sister pharmacy on the opposite side of town. I don’t know how much stock they have but I have a months worth anyway. Good luck to all of you who are searching.
It might be good to start looking a couple of weeks early, Donna. I hope it helps you.
Many of us are on it for the same reasons – not many can tolerate 25mg orally, the max dose for most rheum docs. I’ve only met a couple people on a 30mg dose.
Don’t forget that methotrexate is an important drug in relation to the biologics that many of us are on. The mtx helps to keep the immune system from building up a reaction to the proteins that make up the biologic.
I’m surprised that the pharmacutical companies for the biologics (who are making a mass of $$), aren’t stepping up on controlling the mtx shortage for us. Without this control, we as patients are at risk for losing the effectiveness and even more so, the risk for developing life threatening anaphalaxis to their biologics.
HI Beth. Been trying to reply for about 4 hours. Problems w/ the server. Hopefully over now!
I’ve brought that up on the blog several times and to insurance also – https://www.rawarrior.com/lauras-cvs-commercial-with-kellys-cvs-and-the-a-word/
I agree that “bigger” pharma co that produce biological drugs ought to be “interested” in whether we have access to mtx and I’ve said so.
I use it in oral form and I have been able to get it in Nebraska, however my pharmacy did tell me that they have had problems getting it in — may be because people have been switched from the injectable to the oral.
I’ve just started on injectable MTX and all I can say is no wonder there’s a shortage. I have to drive 40 miles to the hospital pharmacy (where my rheumy is) to get my refills. I can only get 4 weeks at a time. No pharmacy near me has any right now. The weird thing is that they only have 10 ml bottles BUT I can only use each bottle for 4 weeks and THEN I have to bring it back for disposal. That’s 6 ml of MTX going to waste each time I refill!
How many other RA folks are in the same boat? What a boondoggle – I hope this is straightened out soon.
I always use the whole bottle. I don’t know why they are disposing of it Marcia. I’ve had all kinds of prescriptions over the past 6.5 yrs and I’ve never thrown any away. Is it with or w/out preservative? Are you allergic to preservative? I use w/preservative & still refrigerate mine.
Hi Kelly- I’m not allergic to preservative that I know of. They told me that I can only use the bottle for 28 days (4 injections) because of the possibility of contamination. It doesn’t really make sense to me because if I use it more than once, seems to me there would be contamination risk. I was also told not I didn’t need to refrigerate it. Hmmm, clearly there are some things I don’t know. Will be asking some questions at my next visit.
Refrigeration isnt usually required w/ mtx. But it doesn’t hurt it either to be cautious. I clean the top w/ alcohol & like you, I figure that if I can use it 4 times, I can use it 8 times. Needles are sterile and it does have preservative. I think one time I had to get a preserv-free since thats all they had & he told me to refrigerate it that time. You are right if you sense there is a lot of confusion or mixed information out there about this. 🙂
Back in September of 2011 I was told by my Rx insurance company that they were out of stock of injectable mtx so I went to my local large chain pharmacy and was given the 40ml preservative free vial. The pharmacist told me I could use it ONLY ONCE because of the risk of bacterial contamination after the stopper was punctured. I discussed the waste with my pharmacist – knowing of the shortage – and she told me their distributor only had access to the 40ml size.
I didn’t understand why the Pharmaceutical company wouldn’t put the preservative free in 2ml bottles. After receiving 3 of these 40ml bottles I couldn’t in good conscious continue “throwing away” medicine that was in such short supply so I asked my Rheumy to put me on oral mtx. The oral not only doesn’t work as well for me, but the stomach issues were horrendous.
I asked my Rheumy to please switch me back to IM mtx. Well now my Rx insurance company was requiring a blood test to determine if the mtx absorption rate warranted going back to injectable mtx. I was approved and received my first 10ml vial in April 12, but it had to be discarded after 28 days from first use.
FINALLY, I am back to the 2ml vial size which is perfect for my .8 IM dosage.
Not sure if anyone will find this interesting or not, but here is the info on the vials
40ml bottle – Hospira, Inc. ~ Lake Forest, IL Product of Australia
25ml bottle – APP Pharmaceuticals, LLC ~ Schaumburg, IL
2ml bottle – Hospira/Mayne ~ Lake Forest, IL Product of Australia
Gentle hugs and positive thoughts going out to all.
I did not realize that there was a shortage until reading your FB post. Then I started doing some investigating. Both CVS pharmacies near me have a very limited supply. I’m beginning to worry because I don’t tolerate the oral form well and I am going through one hell of a flare right now.
I just got a shock today. For the first time I am finding a HUGE shortage of methotrexate 2.5 mg tablets here in area of Ohio. I was paying $11.30 for a month supply with my Humana Medicare part D card. Today my pharmacist charged $31.39. When I called Humana I discovered that it was the pharmacy, not them, bumping up the price almost 300%!!! I contacted my wonderful pharmacist and he looked into it and found that they are using a new pricing system because the drug is now so very scarce.
So I called around to all the different pharmacy chains, RiteAid, CVS, Walmart, etc…and discovered that MOST of them in my area DO NOT HAVE ANY METHOTREXATE PILLS, and will not get any until at least two months from now!! My HUGE Walmart Superstore had exactly 90 pills in their entire stock. A three month supply for ONE person!
They all say they are on back order….some have had none for two months already.
Now this is ridiculous! There are MILLIONS of us with RA on this drug. And we NEED it to function.
Why in the name of all that is holy is it NOT being manufactured?????
I am afraid of not being able to get my pills next month at all. Then I can be assured of returning to the level of pain and dysfunction I was at when I started on Methotrexate almost 3 years ago.
SHAME ON whoever is at the bottom of this mess.!!!!!!
At my most recent RD appointment the Labcorp tech and I were discussing shortages of MTX. I just found out that the shortage affected the pills as well. I guess that explains why the pharmacy switched generic brands on me two months ago. Wow, this is the first time I am concerned that I won’t have meds I need to function, not a very good feeling. I will find out if the shortage is local to me this week when I submit my refill.
In 2005 (?) there was also a shortage of the injectable methotrexate-a manufacturing problem overseas. The oral kind was ineffective for me. I was really thrown physically and emotionally by it. At that time a lady at the FDA did locate methotrexate for me in Canada and had it shipped to my local pharmacy. She followed up on it, calling me a few days later to make sure I had received it. The ups and downs of the availability had a negative effect on me and I had to discontiue using it. My new rheumatologist feels it would be effective for me. I don’t want the stress of it though – stress is one of my factors for flare-ups and I feel the shortage is artificial to drive the price up and I hate playing their game… Notice the lack of shortage in Canada.
Kelly, I must have somehow got off your mailing list….uggg. Anyway, I am experiencing this in South Dakota. I haven’t had to skip a week yet but my pharmacy (Super Walmart) is only able to get me week by week. I am taking the 2.5 mg oral tablets — just 8 a week. I don’t understand why this is so hard to get. Why can’t the companies make more of this cheap drug that has been around for a long time?
Hi Jane, nice to see you. 🙂
Hopefully this will improve soon. There is a follow up article and more comments here: https://www.rawarrior.com/the-end-of-the-methotrexate-shortage-thanks-to-pfizer/
Thanks Kelly. It sounds like things might be getting better. Sure hope so. I’ve been feeling great the last few months, just stiffness. Then, I get blasted with something that is feeling a lot like a RA Flare after I sent that first comment….oh, it sure reminded me how awful this disease is….it is so easy to forget when the RA has fallen asleep for a while, like a sleeping monster….oh I hate when it wakes up!
OMG!!! I came online looking up Methotrexate because my doc just increased my dose. I suffer from a myriad of complex medical issues, Myasthenia Gravis (a rare disease and an even rarer form of same) being one biggie. This form of MG has accumulated a large assortment of auto-immune diseases, one of which is RA of the pretty severe and disabling kind. Though, I haven’t met an autoimmune disease I am fond of. I worked as a case manager in neurology and multi-trauma for 30 years and was forced to stop working when I was in my early 50’s. I am a fighter and a very positive person. I am just very tired of fighting. As you know it is so very hard and I am so very tired. Anyway…YES! I have had trouble getting my methotrexate from the beginning of being put on it!! Until my just coming across your info I had no idea and neither did my specialty pharmacist at CVS CareMark Mail Order NYS/USA and by local pharmacy in Monroe, NYS, USA. They have been working together to keep me supplied and so far I have been able to get the injectable as long as I allow plenty of time. My nurse will be here tomorrow, I get IVIG every other week for 2 days. She will be interested to read this! Looks like you have some great info. I must say that after working in the field for so long and being enmeshed for 12 yrs trying to get a diagnoses, I have tired myself out and most of what I like to read are things I find enjoyable. Best of luck in your ventures. Barb. Do feel free if you have ant questions I can answer for you.