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Sep 1

Reumofan – a wolf in sheep’s clothing

Reumofan is…

Reumofan (or Reumofan Plus) has been called the miracle drug by many who have used it. Still, others believe Reumofan to be harmful. After my own patients reported their experience with this drug, I decided to take a closer look at the enigma that is Reumofan.

What prompted this blog

Last week I saw a young woman who was referred for evaluation of swelling in her legs. A quick exam made it obvious that her problem was not rheumatologic. “But why do I have this swelling?”, she asked through tears. Her legs had been swollen for about 4 months, and all labs and imaging studies were normal. In addition, she pointed to an annoying rash that had appeared on her entire face for the same length of time. She had already seen a dermatologist and an allergist, but nothing they gave her was working. She was clearly miserable.

We went through everything she had done and everywhere she had been before these symptoms started. “Any new medications?”, I asked, but her answer was no. When I asked if she was taking anything herbal or over the counter she replied, “well, not now, but 6 months ago I took a supplement from Mexico for plantar fasciitis, but stopped it about 3 months ago”. I was not familiar with Reumofan then, but a quick google search revealed concerns that it may contain dexamethasone, a form of steroids. Suddenly my patient’s symptoms made sense: as expected with long term steroid use, she had gained 30 lbs and developed swelling in her legs, in addition to steroid-acne on her face. In addition, she was at risk of adrenal insufficiency, a life-threatening condition that can occur if steroids are stopped abruptly.

After I saw my second patient with lower extremity swelling and weight gain- this time a middle aged man who had taken Reumofan for low back pain- I started to do a more in depth search on this drug. What I found was petrifying. “Reumofan” or “Reumofan plus” has been marketed as a “100% natural”, Mexican herbalary product to treat arthritis, tendonitis, muscle pain, osteoporosis, bone cancer, and a variety of other conditions. It has been sold not only in Mexico, but online in US and Canada.

Review on Reumofan

Blogs dating back to December of 2011 described a magical effect of this drug- aches and pains rapidly disappeared, people reported a “boost of energy”, and they were able to do things they could not previously. By March of 2012 people taking Reumofan started blogging about weight gain, leg swelling, irritability, sleep disturbance, muscle cramps, and abnormal hair growth, among others.

On June 1, 2012, the FDA, working closely with the Mexican government, issued a warning about Reumafen plus. An FDA laboratory analysis of Reumofan plus found that it contains a few hidden ingredients: diclofenac sodium and methocarbamol. The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone. Consumer adverse reports to the FDA included many of the side effects expected with these ingredients.

The FDA updated its warning on August 21, 2012, noting more reports of fatalities, stroke, severe gastrointestinal bleeding, dizziness, insomnia, high blood sugar, and problems with liver and kidney functions, as well as corticosteroid withdrawal syndrome.

Let’s take a look at what these ingredients actually are:

  • Dexamethasone– a form of steroids, it is a powerful anti-inflammatory medication with rapid efficacy but many side effects when used long term. It is one of the medications that I as a rheumatologist commonly prescribe, but would monitor the patient frequently and carefully and try to wean off as fast as possible. It should never be stopped abruptly as that can lead to adrenal insufficiency. Potential side effects include:
            -weight gain
            -water retention (which can cause swelling in the legs)
            -heart failure
            -skin thinning and easy bruising
            -osteoporosis
            -gastrointestinal ulcers and bleeding
            -cataracts
            -steroid acne
            -steroid psychosis
            -adrenal insufficiency when stopped abruptly (some of the symptoms include fatigue, nausea, low blood pressure, dizziness. It can cause death).
  • Diclofenac sodium (Voltaren)- a prescription non-steroidal anti-inflammatory drug (NSAID), similar to ibuprofen, advil, naproxen, aleve, meloxicam, etc. It may be contraindicated in people with heart disease, kidney disease, or those on blood thinners. It also should not be combined with aspirin or other NSAIDS as it can increase the risk. Potential side effects include:
            -gastrointestinal upset, ulceration, perforation, and bleeding (black box warning)
            -increased risk of cardiovascular events like heart attack, clots, and stroke (black box warning)
            -kidney failure
            -increased risk of bleeding in people on blood thinners
  •  Methocarbamol (Robaxin)- a prescription muscle relaxant, which can cause sedation, dizziness, and impaired mental status. Its use is not recommended in people older than 65.

These ingredients may also interact with other medications and result in serious adverse events.

What is the take-home message?

First, if you have taken or are currently taking Reumofan, make sure to alert your doctor. Do not stop it abruptly as it may cause serious problems. Report any side effects to the FDA (click here).

Second, let’s be more skeptical of supplements that claim to be “all natural”, especially if they come from Mexico.  This is not the first time I have seen a supplement from Mexico contain steroids.

Third, just because a product is natural, or claims to be, it may not be necessarily safe. For example, Ginko biloba can cause serious bleeding and Ginsing can interact with Coumadin (a blood thinner). Keep in mind that tobacco is also a natural product.

Finally, if you see a number of side effects listed on FDA-approved drugs, it’s because these drugs have been extensively tested and side effects are carefully reported. The side effects of many “natural” supplements are unknown. While I am a proponent of herbal supplements that have been around for a long time, like turmeric or glucosamine for arthritis, I advise judicial skepticism when considering a new product with promises too good to be true.

Firooz, Dr. Nazanin

Dr. Firooz is board-certified in Rheumatology and Internal Medicine. She is an active member of the American College of Rheumatology, and is affiliated with the Department of Rheumatology at Cedars Sinai Medical Center.

11 comments

  1. Given the side effects of Reumofan vs the side effects of Enbrel, I opted for the Reumofan. While the Enbrel worked great, there are too many systematic side effects and dangers of it. My goodness, what it does to your immune system is enough all by itself.

    We all know that the “found” drugs in Reumofan are used in multiple FDA approved drugs available to us all. Is the FDA not happy because they are not in control of this, or not making revenue?
    Agreed, everything needs to be used with caution, but lets not try to make this out to be the big bad wolf and that the FDA has all the answers.

    Sincerely and respectfully, a medically un-educated user,
    Pete

    1. Dear Pete,

      Thank you for your comment. I appreciate your expressed concern about Enbrel. It is definitely a drug that we do not take lightly, and monitor closely for side effects.

      I encourage you to look up the effects of Dexamethasone on the immune system. This is a form of steroids that was reportedly found in some formulations of Reumofan plus. Believe it or not, steroids are the strongest form of immune suppressants! In the long run, its side effects far outweigh those of Enbrel’s. Personally, if I had a choice between Enbrel and Dexamthasone for a long-term disease, I would definitely pick Enbrel.

      That is not to dismiss the role and efficacy of each of the components found in Reumofan. I use SHORT courses of steroids in my patients to relieve pain quickly- but ALWAYS under careful monitoring. The point is that all these drugs- just like Enbrel- have side effects. Some are contraindicated in people with certain health conditions. Some can be more harmful if used long term. Look at how many side effects and even deaths have been reported in the short period of time it has been available in the US.

      I definitely don’t think the FDA has all the answers- I have my own frustrations with many of its policies. However it is the best way we have to monitor drugs and catalog their side effects systematically.

      Thanks again for opening up this discussion. I wish you the best of luck with your health concerns. I also encourage you to involve your physician in your decision to use or not use Reumofan.

      Best,
      Nazanin Firooz

    2. I guess the same can be said for NyQuil. Each individual ingredient in it is available separately over the counter. Yet we are told to take the individual ingredients as needed based on our symptoms, because it is not a good idea to take more medication than you need. Antibiotics can be an absolute necessity in certain situations, but their over-use or incorrect use can result in anti-biotic resistant bacteria and literally kill us. These have nothing to do with FDA approval or profits.

      Life is a balancing act, with medication it’s often between short term relief and long term risks. One of my kids has severe food and environmental allergies, which means her immune system over-reacts to harmless things like soy and grass. From difficulty breathing to very itchy rash to abdominal pain to constipation to diarrhea to a runny nose that won’t stop for weeks and develops into ear or sinus infections, she has had it all. She has had to use steroids to get symptoms under control at times: oral, nasal, topical, or inhaled. Sometimes it is a must. But it would not be good to have her on steroids continually or long term I am told. Too much risk to her vital organs and muscles, higher risk of getting infections and things because her immune system is suppressed, and even risk of death. An over reactive immune system has its pain and challenges, but a suppressed immune system puts one at great risk too.

      And it’s not just the FDA sounding the alarm on this particular medication. Individual users have done so months before FDA got involved. FDA only gets involved with foreign or natural products when it goes past “anecdotal evidence” and a pattern starts to emerge, percentage of the afflicted becomes “statistically significant,” or “empirical evidence” surfaces.

      -An educated-through-necessity non-doctor

  2. Dr Nazanin,

    Perfect timing. Long story short, I got more Reumofan, which is difficult to do now. I took it for 2 days and the side effects were wild!! Puffy, pain, etc.

    I took Reumofan for a year, felt truly wonderful [psoriatic arthritis], had pain, but I can deal with that. After a year I took a shot of Enbrel a week ago Sunday, it still works…which I was concerned about. I dont like the side effects one bit. Everything from feeling flushed to shingles like itches at times. Just weird stuff, nothing conclusive. I hate the stuff….but. 😉

    Had the Reumofan behaved itself, I would have continued. I have read there are “different” batches or Reumofan. I did notice the pill was a different shade of purple and had similar but different markings. I’m surely not using it now.

    Thanks for your input.
    Pete

    1. Dear Pete,

      Thanks for your comment. Well I’m really glad Enbrel is working for you! I suggest you discuss the side effects with your doctor, as you may not have to suffer them. Sometimes, something as simple as changing the angle of injection or warming the vial to room temperature a little longer may do the trick! If not, you may even consider a different TNF inhibitor if your side effects are persistent.

      Best wishes
      Nazanin Firooz

  3. How should I wean myself off? I have been taking them for about 5 months. One tablet a day. I decided to take a half tab tonight. I’m concerned because I’m having surgery in 2 weeks on my back.

    1. Dear Darlene,

      Thank you for your message. The potential problems with surgery can come from 2 of the possible ingredients: 1) Diclofenac is an NSAID, and all NSAIDs are stopped 1 week before surgery for the potential for bleeding complications. 2) Dexamethasone is a steroid and long term use can cause adrenal insufficiency, and during surgery (which is a stressful situation) you will need a kick from your adrenal glands.

      It seems that not all brands of Rheumofan have the 3 hidden ingredients (dexamethasone, diclofenac and methocarbamol)- but unfortunately we don’t know if the brand you’ve been using may have them or not.

      What I suggest is to talk with your doctor and let them know you have been taking Reumofan for 5 months. Many doctors may be unaware of the controversy surrounding this drug so please do explain that it may contain the 3 ingredients listed above. It is probably wise to wean off slowly before surgery, and you may need a dose of steroids during surgery to compensate for your adrenals. This can be tricky and it’s a good idea to have your doctor help you with the process.

      Best wishes,
      Nazanin Firooz

  4. My problem is only arthritis, and my husband is lower excruciating back pain, numbness on his lower parts of the legs, desperately, seeking something for painless, and comfort. In Oct 1 was introduced to reumofan plus, I took one, and my husband took one, after a couple of hours, we noticed we were going painless, the greatest feeling ever! me and my husband were so excited, about the product, we anxiously wanted to know where we could get it, I looked it up in the internet to order, and the first thing I see is that its not safe, and I was like in denial, how can a pill that makes you feel so good, not be safe, so I ignored it, of course, and went to a different web site, and ordered it, I take the pill every three days, cause thats when I feel my symptoms coming back, and my husband takes it everyday, I am most concerned with my husband because he is diagnosed with type 2 diabetic and also highblood pressure, and is also taking meds for that, (no insylin) I have been reading and resurching on reumofan plus, and becoming more aware of the dangers it has, and how its not safe to stop instantly, Question #1 how do we safely stop taking it?

    1. I suggest that you both talk with your physicians. Make sure to let them know of the possible hidden ingredients just in case they are not familiar with this product. Best wishes!

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