Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA is working with the Mexican government on this matter and an agency order has been issued to recall the product.

The FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps, and adrenal suppression (problems with kidney functioning). An FDA laboratory analysis of Reumofan Plus found that it contains diclofenac sodium, a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, and methocarbamol, a prescription muscle relaxant that can cause sedation, dizziness and low blood pressure, etc.

FDA is urging health care professionals to ask their patients about use of Reumofan Plus and other products marketed dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or abrupt discontinuation of corticosteroids.