Severe Health Risks Associated With Use of Reumofan Supplement Products, FDA Warns

Food and Drug Administration (FDA) warns that consumers should not use Reumofan Plus products due to serious health risks related to the presence of prescription drug ingredients not listed on product labels. In a news release, FDA explains that the products, Reumofan Plus and Reumofan Plus Premium, which are marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions, contain several potentially harmful active pharmaceutical ingredients. Prescription drug ingredients dexamethasone, diclofenac sodium, and methocarbamol have been detected in the products but are not listed on the labeling. These ingredients may interact with other medications and result in serious adverse events. Since FDA issued an initial warning about Reumofan products in June 2012, the agency has received dozens of related adverse event reports, including reports of death and stroke, as well as reports of liver injury, severe bleeding, sudden worsening of glucose control, weight gain, swelling, leg cramps and withdrawal syndrome, and adrenal suppression. The products are manufactured in Mexico by Riger Naturals and sold in the United States in some retail outlets, at flea markets, and on various popular Internet sites. The products are labeled in Spanish; however, versions of these products may also exist with English labeling.

FDA advises health care providers to ask patients about use of Reumofan Plus, Reumofan Plus Premium, and other similar products marketed as dietary supplements when patients present with unexplained symptoms that suggest non-steroidal anti-inflammatory drug toxicity, psychiatric changes, or the use or abrupt discontinuation of corticosteroids. Additionally, FDA states that health care providers should evaluate patients who have used Reumofan Plus and/or Reumofan Plus Premium for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate.

Adverse events related to Reumofan Plus and Reumofan Plus Premium may be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program by completing the online form on the FDA Web site, or by calling 800/332-1088.