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Reumofan Plus is being relabeled by distributors and sold under the name "WOW." FDA is advising consumers not to buy any product with "Riger Naturals S.A." printed on the bottom. FDA has warned consumers twice about potentially harmful side effects from use of Reumofan Plus Products.
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The Food and Drug Administration (FDA) is warning the public that a product distributed and sold under the name 'WOW' is really just another product in disguise, one that can cause serious harm.
Earlier in 2012, FDA twice warned the public about taking Reumofan Plus—marketed as a "natural" dietary supplement for the treatment of many conditions, including arthritis and bone cancer—because, in reality, it contains undeclared active ingredients found in prescription drugs that should only be used under the supervision of a health care professional.
Brad Pace, regulatory counsel at FDA's Health Fraud and Consumer Outreach Branch, says some distributors have deliberately put a new label and a new name, WOW, on bottles of Reumofan Plus to deceptively sell remaining supplies. Pace says WOW has been distributed to online retailers and other distributors, as well as directly to consumers.
FDA is concerned that other distributors will also put different labels on Reumofan Plus and sell it under other names.
The agency offers this advice to consumers:
Since June, FDA has received dozens of reports from consumers who used Reumofan Plus of serious, and sometimes fatal, outcomes. The reports include liver injury, severe bleeding, corticosteroid withdrawal syndrome, adrenal suppression and stroke.
FDA laboratory analysis confirmed that WOW contains the same undeclared prescription drug ingredients that are in Reumofan Plus:
In addition to causing injury on their own, the hidden drugs found in these products could interact with other medications, resulting in serious health consequences.
Because one of the hidden ingredients—dexamethasone—is a corticosteroid, people taking these supplements must work with their health care professional to safely stop taking the drug. A person who abruptly stops taking corticosteroids after long-term use or after taking high doses runs the risk of suffering from a withdrawal syndrome and life-threatening adrenal suppression.
The withdrawal syndrome may include nausea, low blood pressure, low blood sugar levels, fever, muscle and joint pain, dizziness and fainting. Adrenal suppression of cortisol production can be life-threatening because, among its many important roles in the body, cortisol is needed to maintain normal blood pressure and supply glucose to vital tissues, such as the brain and red blood cells, in response to stressors such as trauma, surgery, and infection.
FDA notes that there may be other harmful hidden ingredients in these products. Ingredients may vary from lot to lot, and products found to have hidden drug ingredients are generally not manufactured in a way that would ensure their quality and safety.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
December 21, 2012
Page Last Updated: 02/22/2013
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