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FDA and Mexican Health Officials Recall Reumofan Plus

FDA and Mexican Health Officials Recall Reumofan Plus

June 4, 2012 — The U.S. Food and Drug Administration (FDA) and Mexican Health Authorities are recalling Reumofan Plus, a dietary supplement that is used for arthritis, joint pain, osteoporosis, bone cancer, and more. Although the manufacturers claim it is “100% natural,” Reumofan Plus actually contains pharmaceutical drugs that could be dangerous or deadly.

The FDA has already received numerous adverse event reports related to the supplement, which suggested that the drug contained pharmaceuticals. One doctor’s report suggested that the drug could impair kidney function. Suddenly stopping the drug could also induce fatigue, nausea, low blood pressure, low blood sugar levels, fever, muscle and joint pain, dizziness, and fainting.

When the FDA conducted a laboratory analysis of the ingredients in Reumofan Plus, they found that it contained the following drugs:

  • Diclofenac sodium: A prescription NSAID (non-steroidal anti-inflammatory drug) that can interact with other medications and increase a person’s risk of heart attack, stroke, and gastrointestinal events including ulcers, bleeding, and holes in the stomach or intestines.
  • Methocarbamol: A prescription muscle-relaxant drug with adverse effects that include sedation, dizziness, and low blood pressure. A person taking this drug may have an impaired ability to physically or mentally drive a car or operate heavy machinery.
  • Dexamethasone: Mexican health authorities discovered this ingredient in at least one lot of Reumofan Plus. The ingredient is a pharmaceutical drug that is an anti-inflammatory that also suppresses the immune system.

The FDA is also warning that these ingredients can interact with ingredients in other drugs, with unintended consequences.

Reumofan Plus is manufactured by Riger Naturals, a Mexican company. It is sold in some stores, flea markets, and on the internet. There is a Reumofan USA website, but it refers all inquiries to the Mexican-based company.

The FDA is specifically warning doctors to ask their patients if they are taking Reumofan Plus and other products marketed as dietary supplements. Because the FDA does not have the ability to conduct laboratory tests of all dietary supplements, it is possible that there are more which contain pharmaceutical drugs.

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