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MS Drug Tecfidera More Trouble Than It’s Worth?

MS drug Tecfidera

People with multiple sclerosis who take the MS drug Tecfidera may want to listen up. Others who are considering the medication should pay attention as well.

Why? At the recent joint meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis, experts presented a number of reports on the side effects associated with the use of Tecfidera (dimethyl fumarate). The findings are substantial enough to cause potential and current users of the drug to think about the findings.

Trouble with Tecfidera
More than 50 percent of patients who participated in an open-label study by the drug’s manufacturer (Biogen Idec) required over-the-counter (OTC) drugs to help manage diarrhea and stomach upset associated with Tecfidera. Among patients who kept taking the drug, the symptoms eventually resolved after two months. About 25 percent of patients who switched to Tecfidera after taking another MS drug stopped taking the drug completely within three months.

In a University of California Los Angeles study involving 30 patients, five (17%) stopped taking the drug because of gastrointestinal side effects (with one developing splenomegaly), 13 reported significant side effects (e.g., nausea, vomiting, bloating, and/or diarrhea), and 12 had minimal or no side effects. Another finding was that three patients who stopped taking Tecfidera had high eosinophil levels, which is an indication of infection.

A Lexington, Massachusetts study of 104 patients revealed that 57 percent experienced gastrointestinal symptoms during the first 30 days of treatment. By month three, 11 percent still had the problems.

In that same Lexington study, 51 percent experienced flushing during the first month of treatment, and that percentage was halved during subsequent months. In addition, 13 patients stopped treatment completely mainly because of GI adverse effects and 25 percent developed leukopenia or lymphopenia at month six.

Of the 66 MS patients who participated in a University of Texas Southwestern Medical Center study, only 18 percent suffered no side effects. The others experienced flushing (44%), GI symptoms (51%), or itching (12%). OTC medications such as aspirin, loperamide, antihistamines, and bismuth drugs were used to treat the side effects.

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However, some patients suffered persistent problems and needed prescription drugs such as montelukast and glycopyrrolate. Overall, 26 percent of the patients stopped taking Tecfidera because of the side effects.

Biogen Idec funded several post-marketing studies of Tecfidera. One study of 233 patients found that 206 of the participants experienced a GI event during the four-month study and 126 required an OTC medication for the symptoms. Ten percent of the patients stopped treatment because of side effects.

In another Biogen Idec sponsored study, it was confirmed that up to 3.6 percent of patients who took the drug for 96 weeks developed lymphopenia. This is a condition characterized by low levels of white blood cells (lymphocytes) that fight infection.

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Adverse events and other problems with medications such as the MS drug Tecfidera are often revealed after they hit the market. Postmarketing studies as well as reported experiences by patients can expose significant problems with these drugs.

Some patients with MS fare well on Tecfidera while others do not. Talk to your healthcare provider, do your own research, and be an informed consumer before you take the MS drug Tecfidera or any other medication on the market.

Read about vitamin E for MS

Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis

Image: Pixabay



This article gives #s of patients with various side effects. Nothing more. It seems no different than reading the information that is provided when a patient begins the drug. It gives no information on these side effects vs those experienced by people who take any other MS drug. It gives no information on the efficacy of Tecfidera. The pills pictured in the photo are not even Tecfidera capsules. I'm left wondering what, exactly, was the point of this article?
Hi I have started Tecfidera because after 7.5 years of Copaxone my skin was so damaged that it was becoming almost impossible to find anywhere to put an njection into my skin. Also once in I think my skin was so damaged that the copaxone was just sitting in one place and was not dissipating. When I was first shown techniques of injecting they recommended putting a cool thin maluble plastic container filled with a liquid ( which I kept in the fridge to keep it cool) onto the injection site after I had had my injection. Apparently the company that makes copaxone stopped giving this advise that they used to do because all though the cool gel in the plastic container that they suggested is applied onto the injection site after one has had an injection does give some physical relief, it is now thought to be bad practise because using a coolant causes all the peripheral blood vessels to shut down meaning as the injection is shallow injection then shutting the near to the surface blood vessels down by applying something cool may very well slow down the drugs absorption and thus the medication is likely to sit in one place for longer causing increased risk of damage to the dermis and epidermis levels of the skin - thus as the skin is damaged further then the skins ability to absorb the medication is impeded. Why they do not pass on new guidelines I just do not know. I personally believe it is to do with the drug company offering to provide injection training as part of the cost that the NHS pays for copaxone. Unfortunately although this might seem attractive to purchesers of copaxone ( NHS) because they do not have to use their own personel for injection training but because this element of health care comes under the cost of supplying the copaxone then health authorities will inevitably take up the drug company's offer. However if the drug company give initial training and then do not follow up this training with new advise as it becomes known then the people who are injecting the medication do not get the appropriate new advuse once it becomes known. Consequently it may well be that my skin has become very much more damaged than it should have done. The result of this is that I can no longer take copaxone because my skin will not tolerate copaxone any longer. This means I have moved on to Tecfidera which costs about 3 times as much as copaxone. Consequently the NHS have not saved money by permitting the manufacturer of the drug to attend to the trains as the NHS now has to pay substantially more than my previous medication. The other problem with copaxone was the unbelievably poor quality of the autinjector. The auto injector that copaxone supplied was so cheap and useless to use that again additional additional damage was done to my skin. One would calibrate the auto injector to 6mm depth but because the autinjector was such poor quality that one coukd no be sure if the autinjector would stay set at the depth required, the auto injector was so poorley made that the depth of the injection loaded into the auto injector could vary from up to 2mm each way. In other words the auto injector would be set at 6mm depth but by the time the medication from injection had been delivered it could well have been delivered to the depth of only 4mm (to shallow) to 8mm (to deep) so that the medication injected was not delivered to the correct depth and so potentially much more damage to the skin which in turn meant that the kength of time that one coukd tolerate the drug was undermined because of the ineffectiveness of the auto injector provide by copaxone. Copaxone has at last produced a much better auto injector but all though new people might receive the new style autinjector people allready using copaxone may still very well be using the old type injector with all the negatives consequences associated with the old injector.,if you are on copaxone now and have not recieved the new style auto injector then ask copaxone for one of these new autominjectors ASAP, so as to lessen the high risk of using the sub standard auto injector which can potentially damage ones skin very much faster. Demand your new auto injector ASAP so as to try and reduce the constant damage to ones skin by requesting and using the new auto injector ASAP. Ps inam now on Tecfidera and have had problems getting onto it. Side effects with tummy and gastro system etc. I am also getting an amount of flushing. Does anyone know what causes the flushing, does the drug make ones blood thicker or puts ones blood pressure up? I know they suggest aspirin to counteract flushing but I really would like to know what causes the flushing. This level of detail about side effects seems to be scant and poor. We really do need to know why one gets a side effect like flushing. What is happening in the body to cause flushing in the first place. Ok it is useful to know how to reduce a side effect, but knowing why one gets this or that side effect is actually really important to recieve informtion about but we do not seem to recieve such important info so we can work out a risk reward exercise.
Thank you for reading the article. It appears you are well informed about the potential side effects of Tecfidera. Unfortunately many MS patients are not, and a lack of information and understanding about what drugs one takes is certainly not limited to people with MS! The article covers information recently discussed at the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis. Thus it serves as an informational piece for individuals with MS who may be interested and otherwise uninformed about what experts have to say about the drug and its adverse effects. This article was not meant to address efficacy...that would be another article. As for the photo--I chose it for effect.
I have been using Tecfidera since October 2013. Once I realized that spicy food went hand in hand with the flushing and gastro issues, I cut out the spicy foods. The issues have pretty much disappeared. Maybe they should work food consumption into the next study. Seems like common sense to me. I currently take 2 blue, 240MG tablets twice a day. My MS has not progressed since taking Tecfidera. It has not cured my symptoms either.
Thank you for sharing your experience with Tecfidera. It is important for anyone who is currently taking or who is thinking about taking Tecfidera (or any drug, for that matter) to have as much information about the medication as possible. You have brought up a point about diet that definitely should be part of the discussions patients have with their healthcare provider. At the same time, many doctors have little background in nutrition. I have spoken with MSers whose doctors have downplayed the role of diet. As healthcare consumers, we can learn much from each other, keeping up with the literature, and asking questions of our doctors and other experts. I wish you continued success.
I completely disagree! Tecfidera is the best drug I've taken so far! Compared to the others these side effects for me, were mild to inconsequential. Let's compare...Tecfidera side effects (for me)--1-2 weeks of gastrointestinal, flushing, uhhh that's it. Avonex- deep muscle injection, flu like symptoms, possible liver failure( happened to my friend). Copaxone-injections that destroy skin, liver issues, feeling like your having heart attack (happened to me) again injections DAILY. Soo the comparisons are pretty obvious and yet you are making people think it is horrible. The forums are full of people scared to death of Tecfidera when it might be perfect fo them. It is for me!
Does or did it stop flare ups
While on tecfidera have had serious gi effects(nausea) little flushing, serious nasal congestion and constant nightly shortness of breath? I was taken off the medication for 3 weeks entirely yet the nausea,shortness of breath and conjestion have continued. I have been told to do the starter pattern again but instead of two weeks at a time for escalating dosages to increase the time between dosages to get get use to increasing dosages, it has been 3 and a half weeks on just 120mg and the side effects continue, I am feeling leg weakness and fearing sleeping for breathing sorry I'm out.
And i completely disagree with you.After 16 years of injection I switched to Tecfidera and I have now decided to drop it. Gastroinstestinal effects were lasted days and days and were so severe thatI had to be hospitalised. i stopped tecfidera and my stomach, spleen, tummy still hurt. So, we are all different.
Update year three! I am a working, active 48 year old Mom with an 11 year old. Tecfidera has been great and I have only had one minor exascerbation in 3 years. However, this summer despite the fact that I have only taken 1pill a day quite a bit my lymphocyte levels have gone down to 518 and they have been around 600-700 for a while so the doc wants me to switch. Sigh. Tecfidera has been good to me and I still recommend it.
I am glad Tecfidera has helped you. But like all drugs on the market, some work for some people while they are not helpful at all or are harmful to others. Pencillin is a life saver for some but dangerous for others. I did not make "people think it is horrible." I simply reported the findings of research. I have heard from people who had a bad experience with Tecfidera. The article is meant to provide information so people can make informed choices. That is what all healthcare seekers deserve.
Ive been taking Tecifidera for about 7-8 months after the initial side effects I've had no problems. Yes, people need information about Tecifidera but that information should be compared to the other MS medications so people can compare the side effects of all the medications. Every MS medication has some sort of side effect so why just give the side effects of Tecifidera? As far as I'm concerned things like Avonez, Copaxone have far worse side effects and your putting a needle into all the time which can lead to infection, site injection problems along with lots of side effects as well. Every medication you take has side effects, but it's your responsibility to be well informed about the medications they take.
I cant stand the bloating that I still feel after approx 6 months. I do have bouts with consipation still (seems to be like a flare up:stress or MS?) I do like that I dont have to give myself shots and dont miss the crappy flu feeling. But I am an active person with a bloated belly and I really dont like the weight I have gained since taking.
Sounds exactly like me! I've been taking Tec for just over 3 years. I've gained 50(!!) lbs. I don't like how I feel from the weight gain, but have had minimal ms related concerns. I have even considered discontinuing the medication because I can only assume it's going to get worse. But then I question myself and wonder if I really am that vain? Sometimes the answer is yes! I can carry an extra 5 lbs and the bloating is awful. Swollen ankles, belly and puffy everything else! I've spent a lot of money too, always needing to go up a size. I've ranged from a size 2 (at my smallest) to currently a size 12, comfortably a 14, thankfully I'm 5'08. But I can see it and feel the weight as well. Not fun! I feel your pain on this!
I am having the exact same problem. I've gained 50 pounds in a year, gone up several size if clothes several time which is expensive and a blow to your self esteem. I feel bloated and my ankles are swollen. Carrying this extra weight is exhausting.
I had to stop taking Tec back in April. I was uncomfortable and the weight gain was rapidly increasing. I instantly dropped abt 20 lbs! The bloating is gone too! Btwn the weight gain and hair loss, I was feeling pretty down abt myself. It was helping the ms tho so it was a tough decision to stop. Best of luck to you!
Thank you, Kandy, for sharing your experience with Tecfidera. Everyone has a different experience with the drug, and it is important for patients to have information so they can make an informed decision.
To Deborah Mitchell on June 18, 2014; It is about the way your provide the information, not the information itself. I think that's what Belinda wanted to point out. If not, i'm sorry, but then i'll do it. Yes, the studies show nothing but facts, and there's nothing wrong with that. But maybe there would have been a better and more moderate way of presenting these results. I don't blame you for writing "against" this Company (In my perception you are doing it, but feel free to prove me wrong). Maybe, just maybe the positive effects (as mentioned in the Titel) are worth it in some cases. So an example like Belinda would have given the article a fair touch. The article is a bit one-sided, but that's ok because we have freedom of speech. So, Keep up the good work Deborah and please dont feel offended. Best regards Chris
Chris: Thank you for writing back. I am not offended; I understand your position and appreciate your candor. I don't feel like I wrote unnecessarily "against" this one drug company--in fact, I think all health care consumers need to be wary of all pharmaceutical companies, their products, and testing procedures and results. Yes, the article is a bit one-sided, but I do offer a carrot in the last paragraph, noting that some patients do well on the drug. If someone has success with any medication, and they are fully informed about what is known about potential side effects and complications, I believe that is a noble goal. Also, one goal of writing any piece is to spark interest, discussion, and emotion. I apparently have been successful to some extent with this short article. Thank you for continuing the discussion.
I've been on tecfidera since last august and love it! The only issue I've ever had is randomly ill get flushed but that either resolves itself in a half hour or an aspirin takes care of it. I've been on this, gilenya and copxone and this is my favorite because of ease of use and safety but I had no issues with other drugs. The pic doesn't even represent tecfidera which is kinda funny and the stats seem to be such a small sample size that it's hard to gauge. Go with what your neuro says and hopefully this works for you!
I have been on Tecfidera since feb.2014 when diagnosed, now 8 mths later, nothing serious like at times I feel flushing but no diarrhea or vomiting. No other problems, Thank God.
Please tell me how was your flare ups... I had a problem in Nov then in April and that's when I got diagnosis. . And now I have a flare up 9.20.14 present mines seem to be 5 to 6 months flare ups with in this last year.. hit me back ASAP I was on tec but stopped maybe that's why flare up came but it was a six month gap when I wasn't taking medicine...
I've been on Tecfidera 10 months and up until recently thought it was the best thing since sliced bread! I have had flushing, on and off, for the entire time. Aspirin helps but doesn't get rid of the flushes entirely. The last three months though have been horrid... never ending chest infections, asthma that doesn't respond to steroids and feeling tired ALL the time. Have just discovered that not only is my lymphocyte count down around my boots; so too are all my immunoglobulin G class counts. My immune system has essentially crashed and the major suspect is Tecfidera. I've got a six week wait to see an immunologist and can't find any info about whether this kind of immunology problem has been seen much with Tecfidera. Any clues??
Gill: I am sorry to hear you are having so much difficulty. I am not a doctor, but according to reports I have read, Tecfidera frequently causes flushing and fatigue and it can lower lymphocyte levels. I do not know about the IgG levels nor the chest infections, although the latter may be a result of a compromised immune system. I wish you good luck with your doctor and hope you find effective treatment.
I hate the man made meds.... I use gingko for my symptoms it's been working drugs from earth
A year later, how are you? I'm on this now but stopped 2weeks ago. Similar issues, I am choosing not to be a pharmaceutical guinea pig. God bless you. Hope things are better now for you.
Immune system dysfunction is one of the serious side effects of Tecfidera. Don't wait six months to see a doctor.
Diagnosed in June 2014, been on Tecfidera 240g twice per day since July. No new or relapse of MS symptoms yet (some never went away). No side effects initially, but recently have been getting flushing about every other day...which is getting difficult to hide from coworkers when my neck suddenly looks completely sunburned :). Haven't figured out any triggers yet, but really not that bad of side effect compared to what I've read about other meds.
I have been on Tecfidera for 4 months now and you name the side effects I've had them, and I am still getting them now. It's not fun and since I've only been diagnosed for 5 months with MS I'm kind of a newbie. I know a lot of people with MS and they all say this new "wonder drug" is the best thing. Yes its stopped my relapses but the side effects are making me doubt my decision. And now I get a letter through saying someone has died after being on Tecfidera because her white blood count cause PML scary stuff. But if we don't try it we'll never know it works for some but not for others. Research is key!
Lynne: Thank you for sharing your experiences with Tecfidera. As you probably know, people have wide ranging opinions and experiences with this (and other) drugs for MS. I also believe that research is critical, although I also think we must be very cautious about who does the investigations and who funds them. Like so many serious health issues, treatment of MS is a topic of much debate and controversy. Since each of us is unique, what works for one will not for another, even if symptoms and other factors appear to be similar on the surface. Each of us is charged with becoming as familiar as possible with as many possibilities for treating and managing MS as possible, from diet to drugs and alternative therapies. I wish you health and well-being.