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Copyright 2013 Natural Standard (www.naturalstandard.com)
June 2012

FDA Warning: Dietary Supplement Reumofan Plus May Contain Harmful Drugs

The U.S. Food and Drug Administration (FDA) has posted a warning to consumers that Reumofan Plus, a product marketed as a natural dietary supplement for relieving pain and other conditions, contains possibly harmful pharmaceutical ingredients that are not listed on the supplement label.

Reumofan Plus, a Spanish-labeled product that manufactured by Riger Naturals in Mexico, is marketed as a remedy to treat arthritis, bone cancer, muscle pain, and osteoporosis. The product is sold in certain retail outlets, and well as at flea markets and on some internet websites.

As a result of the unlabeled ingredients, the FDA has received reports of several mild and serious side effects, including liver injury, uncontrolled sugar levels, weight gain, swelling, cramping in the legs and kidney dysfunction (adrenal suppression). These side effects are likely due to the presence of various drugs that are not listed on the label of Reumofan Plus.

Based on laboratory studies, the FDA determined that Reumofan Plus contains diclofenac sodium. Diclofenac sodium is a non-steroidal anti-inflammatory drug (NSAID) that requires a prescription to use. Side effects of this drug include heart attacks, stroke, bleeding, ulceration and the formation of holes in the stomach or intestines that may lead to death.

In addition to diclofenac sodium, the FDA also determined that Reumofan Plus contains methocarbamol. Methocarbamol is a muscle relaxing drug that also requires a prescription to use. Side effects of this drug include tiredness, dizziness, reduced blood pressure and reduced mental and physical abilities. Furthermore, both methocarbamol as well as diclofenac sodium have the potential to interact with other medications.

Prior to the FDA's analysis of Reumofan Plus, the Mexican Ministry of Health discovered that at least some batches of the product contained dexamethasone. Dexamethasone is a corticosteroid that functions as both an anti-inflammatory and immune-suppressing agent. The Mexican Ministry of Health went on to order Riger Naturals to recall Reumofan Plus, and issued a warning to consumers regarding the potential health hazards associated with the product.

According to the FDA, several of the side effects that have been reported for Reumofan Plus may be caused by the corticosteroid content. For instance, suddenly stopping the use of corticosteroids after using the drug over long periods of time or at high doses may cause tiredness, nausea, reduced blood pressure and blood sugar levels, pain in the muscles or joints, dizziness, fainting or fever.

Consequently, if patients report symptoms similar to NSAID toxicity, depression or corticosteroid use and/or discontinuation to their physician, the physician is recommended to ask the patient about use of Reumofan Plus. Furthermore, patients who report using Reumofan Plus should be evaluated by their physician for possibly drug interactions involving diclofenac, methocarbamol, and corticosteroids. The physician should determine whether the patient should undergo a corticosteroid taper regimen.

The FDA recommends that people who are currently using Reumofan Plus or who have recently discontinued use of this product should contact their physician or healthcare provider. Furthermore, the FDA recommends that future purchase of this product be avoided.

Despite the FDA's warning regarding this particular dietary supplement marketed for pain relief, various other integrative therapies have shown potential benefit in treating pain or related symptoms. Listed below are examples of integrative therapies that have shown strong or good scientific evidence for relieving pain.

Acupuncture: strong scientific evidence for relieving chronic pain

Acupuncture: strong scientific evidence for relieving post-operative pain

Acupuncture: good scientific evidence for relieving pain associated with endoscopy procedures

Acupressure, shiatsu, tuina: good scientific evidence for relieving general pain

Cayenne: good scientific evidence for relieving post-operative pain (plaster at acupoint)

Clove: good scientific evidence for relieving dental pain

Comfrey: good scientific evidence for relieving inflammation

Comfrey: good scientific evidence for relieving pain

Guided imagery: good scientific evidence for relieving pain

Hypnotherapy, hypnosis: good scientific evidence for relieving pain caused by various conditions

Marijuana: strong scientific evidence for relieving chronic pain

Music therapy: good scientific evidence for relieving adjunct pain

Physical therapy: good scientific evidence for relieving pain

Therapeutic touch: good scientific evidence for relieving pain

For more information about integrative therapies with evidence for reducing pain, please visit Natural Standard's Medical Conditions Database.

References

  1. Natural Standard: The Authority on Integrative Medicine. www.naturalstandard.com
  2. U.S. Food and Drug Administration (FDA). www.fda.gov
The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright 2013 Natural Standard Inc. Commercial distribution or reproduction prohibited.