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FDA Issues Safety Alert on Reumofan Plus and Reumofan Plus Premium

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By: Sean Moloughney

Editor, Nutraceuticals World

The U.S. Food and Drug Administration (FDA) has issued a new warning to about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products, Reumofan Plus and Reumofan Plus Premium, contain several potentially harmful active pharmaceutical ingredients that are not listed on the product labels. FDA has received dozens of additional adverse event reports, including death and stroke, associated with the use of Reumofan Plus since the agency issued its first warning about the product on June 1, 2012. Other reports include liver injury, severe bleeding, sudden worsening of glucose control, weight gain, swelling, leg cramps and withdrawal syndrome, and adrenal suppression. Ongoing FDA laboratory analyses of Reumofan Plus found that it contains the prescription drug ingredients dexamethasone , diclofenac sodium, and methocarbamol. The products are manufactured in Mexico by Riger Naturals and sold in the U.S. in some retail outlets, at flea markets, and on various popular Internet sites.

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