NMA: Nonprescription Medicines Academy

Patient Safety Alerts

August 29th, 2012

FDA Issues New Warning About Reumofan Plus
The FDA has issued a new warning about the potential health risks of Reumofan Plus and Reumofan Plus Premium, marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products contain several potentially harmful active pharmaceutical ingredients that are not listed on the product labels, including dexamethasone, diclofenac sodium, and methocarbamol. The 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. Reumofan Plus and Reumofan Plus Premium are labeled in Spanish; however, versions of these products with English labeling may also exist. The products are manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various Internet sites.