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Reumofan Plus is marketed as a '100% all natural dietary supplement' but in fact contains prescription drugs, says the FDA
Lab tests on Reumofan Plus, a dietary supplement made in Mexico and marketed as a natural pain reliever, show that it contains at least two prescription painkillers, the Food and Drug Administration (FDA) has warned.
An FDA laboratory analysis of the product - described on websites such as reumofan-plus.org as a “100% all natural dietary supplement” containing Eastern Teaberry, White Willow and Curcumin - revealed that it also contained the prescription drugs Diclofenac Sodium (a non-steroidal anti-inflammatory) and Methocarbamol (a muscle relaxant).
Diclofenac Sodium, Methocarbamol and Dexamethasone
These active pharmaceutical ingredients may cause increased risk of heart attack and stroke, gastrointestinal bleeding and ulceration (Diclofenac sodium) and dizziness, drowsiness and low blood pressure (Methocarbamol), claimed the FDA.
Multiple AERs
Meanwhile, the Mexican Ministry of Health has also discovered that “at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant”, said the agency.
“FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression."
Product recall
Labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions, Reumofan Plus is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites, said the FDA.
“FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.”
Active pharmaceutical ingredients
While there is no hard data to suggest that the spiking of dietary supplements with unauthorized active pharmaceutical ingredients (APIs) is a growing problem, it has become a talking point this year following a Dr Oz episode devoted to it in January.
Speaking to NutraIngredients-USA after the show aired, James Neal-Kababick, director of Oregon-based lab Flora Research Laboratories, said that some of it was deliberate spiking, and some of it was inadvertent contamination.
He added: “We’re seeing more deliberate spiking with high levels of APIs but also more samples with low level contamination.”
Sloppy manufacturing
In the latter case, this might be due to manufacturers producing supplements in facilities that are also licensed to produce drugs, or where manufacturers are making counterfeit drugs and then producing ingredients or dietary supplements out of the same facility, he said.
“Some of these companies use compressed air to clean up kit between batches – which can leave residues - instead of properly washing down the facility and then validating the cleaning as per pharmaceutical standards.
“I’d say that this low level contamination is a more recent phenomenon and it concerns me, because it is sloppy manufacturing.”
He added: “What is also worrying is that while most of the spiking is in weight loss, sports and male virility products, we’re also seeing more in anti-diabetic blood sugar support products, where we have detected anti-psychotic and blood pressure meds.”
3 comments (Comments are now closed)
short lived relief
I took Reumofan for two weeks,starting at 1 every 12 hrs, then once a day. I have had Rheumatoid arthritis for 16 yrs and have been taking 5mg prednisone a day to keep it somewhat in control. I cut down on the prednisone while on Reumofan and after 10 days I felt like I didnt have R.A.! Energy, no pain and R.A. nodules on my elbow vanished!!! Havn't felt that good since before I got sick. I quit taking them after news of recall and am back at square one, hurting & tired. Strongly thinking of going back on Reumofan since the only thing my dr wants to do is put me on biologics that can cause heart liver eye problems and CANCERS. Ya... not me!
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Posted by Wanda Scholz
31 July 2012 | 04h32
reumofhan
es horrible vivir con dolor toda la vida y si hay algo k lo mitigue lo usas de todosmodos morir es inevitable mas mal ya no se puede estar tal vez no sea el medicamento adecuado pero al menos ya no duermo con dolor y camino sin dolor solo hay k cuidar muchisimo la dieta
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Posted by rosalba sanchez
23 July 2012 | 10h30
reumofan plus
So we are all so hang up on ourselves, that we think if it is not manufactured in the USA is NOT GOOD, REALLY? SINCE WHEN? Aren't the American pharmaceuticals selling medications that have killed and are killing millions of people worldwide? Don't we all know that the the FDA conspire with the pharmaceuticals. Don't we know that some medications get banned from the market after 100 people have died. Reumofan IS THE BEST THAT HAS EVER HAPPENED TO ME. For the first time in my entire life i am free of pain and my glucose reading in the AM are 106 and 113 VS 240 before. It gives me energy, and what I am saying can be said by the dozens of friends and relatives that I have recommended the product to. All of you had to find something wrong with Reumofan Plus for the tremendous success it has had in this country and abroad. The pharmaceuticals along with the FDA can not tolerate that such a good product is not "approved" by them. I have been taking medications for my arthritis and all I have gotten is getting sicker and the pain persists. I am taking Glipizide for my diabetes, and as I said before my glucose was high, but after taking Reumofan my glucose has gone down. So entertain yourself with something more productive. Research the "approved" FDA medications and then criticize Reumofan, because it is made in Mexico. Let us stop being so darned proud of our USA products and face reality and the truth. FDA IS SOLD TO THE VERY RICH AMERICAN PHARMACEUTICALS.
Thank you
Kathy Henderson
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Posted by kathy
14 July 2012 | 19h52