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Copyright © 2017 Natural Medicines (www.naturalmedicines.com)
January 2013

FDA: Supplement May Contain Prescription Drug Ingredients

The U.S. Food and Drug Administration (FDA) recently issued a consumer warning for WOW, which contains unlabeled prescription drug ingredients with potentially adverse effects.

WOW was sold on several websites, including www.gonepainfree.com and www.browerent.com. WOW was marketed as a remedy to treat arthritis, bone cancer, muscle pain and osteoporosis.

According to the FDA, WOW is the relabeled version of Reumofan Plus, which caused several mild and serious side effects from Reumofan Plus. Subsequently, the FDA issued warnings against Reumofan Plus in June and August 2012.

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.

The FDA advises consumers in possession of WOW or Reumofan Plus to discontinue use immediately. Any negative side effects should be reported to a healthcare provider and the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

For more information about integrative therapies for pain relief, please visit Natural Standard's Comparative Effectiveness database.

References

  1. Natural Standard: The Authority on Integrative Medicine. 
  2. US Food and Drug Administration. www.fda.gov

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