FDA: All-natural dietary supplement Reumofan Plus contains prescription drugs

By Elaine Watson

- Last updated on GMT

Related tags: Food and drug administration

Reumofan Plus is marketed as a '100% all natural dietary supplement' but in fact contains prescription drugs, says the FDA
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.”

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4 comments

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reumofan plus

Posted by Ana,

I took reumofan plus one pill per day for 2month and enhance the overall wellness...I can found anymore...Live in pain,inflammation at my fingers joins..

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short lived relief

Posted by Wanda Scholz,

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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reumofhan

Posted by rosalba sanchez,

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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