December 20, 2012 — The U.S. Food and Drug Administration (FDA) is warning that the recalled dietary supplements Reumofan and Reumofan Plus has been re-branded as “WOW” with the same illegal prescription drug ingredients. Although the FDA issued a recall of Reumofan, the manufacturer continues to sell it online as a treatment for arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The manufacturer has also refused to issue an adequate recall of Reumofan or “WOW.”
According to Melinda Plaisier, FDA’s Acing Associate Commissioner for Regulatory Affairs:
“FDA is prepared to take aggressive enforcement action to protect consumers from these dangerous products, including seizure, injunction, and pursuit of criminal prosecution.”
In the meantime, the FDA is warning the public not to buy or use Reumofan or “WOW.” Any patients who are currently taking these drugs should contact a healthcare professional immediately, because they may require a tapering schedule. Healthcare professionals should also ask their patients whether they are taking the products.
Reumofan and “WOW” are marketed as dietary supplements, but they are illegally marketed because they contain the following drug ingredients:
- Dexamethasone: A corticosteroid
- Diclofenac sodium: A non-steroidal anti-inflammatory drug
- Methocrabamol: A muscle relaxant
These prescription drugs are not listed on the label of Reumofan. These ingredients can interact with other medications and potentially cause severe injury. The FDA has warned about the dangers of Reumofan in June and August 2012. The warnings were in response to dozens of adverse event reports, including the following:
- Liver injury
- Severe bleeding
- Corticosteroid withdrawal syndrome
- Adrenal suppression
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