FDA Warns Consumers of Dangerous Relabeled Supplement "WOW"

WASHINGTON FDA is warning the public that Reumofan Plus a dietary supplement that is potentially extremely harmful and marketed to treat such conditions as arthritis, bone cancer, muscle pain and osteoporosis is being relabeled and sold under the name WOW.

The agency said its lab analysis confirmed WOW contains the same prescription drug ingredients that are found in Reumofan Plus.

FDA noted the ingredients including dexamethasone (a corticosteroid), diclofenac sodium (a non-steroidal anti-inflammatory drug) and methocrabamol (a muscle relaxant) can cause grave injury. In fact, FDA said it has received reports since June of liver injury, severe bleeding, stroke and even death from consumers who have used Reumofan Plus.

These dangerous products should simply not be sold or distributed," said Melinda Plaisier, FDAs Acting Associate Commissioner for Regulatory Affairs, in a statement.  FDA is prepared to take aggressive enforcement action to protect consumers from these dangerous products, including seizure, injunction, and pursuit of criminal prosecution." 

The agency is advising consumers not to purchase or use the products and recommends that consumers who have taken Reumofan Plus or WOW immediately consult a health care professional.

The products are sold on various websites, including www.gonepainfree.com and www.browerent.com, and manufactured by Riger Naturals S.A, FDA said. The agency also said various websites, including www.reumofanusa.com, continue to sell Reumofan Plus in spite of previous FDA warnings, and it's concerned other distributors may be relabeling Reumofan Plus products and selling them under other names.

"FDA has been in contact with both Brower Enterprises and Reumofan USA, LLC about voluntarily recalling the dangerous products," the agency said. "At this time, neither firm has adequately alerted the public about the safety risks associated with the products."