Dangerous Supplement Again
April 19, 2013
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.
Serious Health Risks
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:
- dexamethasone—a corticosteroid used to treat inflammatory conditions such as asthma and rheumatoid arthritis, that can increase the risk of infection, and cause increased blood sugar levels, changes in blood pressure, damage to bones, psychiatric problems. When taken for a prolonged period at high doses, it can cause adrenal suppression.
- diclofenac sodium—a non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events, such as heart attack, as well as serious gastrointestinal problems.
- methocarbamol—a muscle relaxant that can cause sedation, dizziness and low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.
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.