MS Drug Tecfidera More Trouble Than It’s Worth?

2014-06-03 09:00
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.

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.

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

Image: Pixabay

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Comments

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?
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
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.
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