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FDA Issues Warning About Potentially Deadly Supplement

The hidden dangers in the largely unregulated supplements market came back into the limelight again this week when the Food and Drug Administration (FDA) issued a warning to consumers about the risks they face by taking Reumofan Plus and Reumofan Plus Premium, popular dietary supplements which can cause serious and even fatal side effects.

According to an FDA notice, Reumofan Plus and Reumofan Plus Premium contain undeclared active ingredients found in prescription drugs that should be used only under the supervision of a health care professional. After receiving reports of adverse events associated with Reumofan Plus, FDA analyzed the product in one of its laboratories and found that it contains the following drug ingredients:

• diclofenac sodium—a prescription 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 prescription 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.

• dexamethasone— a corticosteroid used to treat inflammatory conditions such as asthma and rheumatoid arthritis, which can increase the risk of infection, increased blood sugar levels, changes in blood pressure, damage to bones, psychiatric problems and adrenal suppression.

Since June 1, 2012, when FDA first warned the public about the dangers of these supplements, the agency has received reports of fatalities, stroke, severe bleeding in the gastrointestinal tract (including the esophagus, stomach and intestines), dizziness, insomnia, high blood sugar levels and problems with liver and kidney functions, as well as corticosteroid withdrawal syndrome.

“Consumers who are currently taking Reumofan Plus or Reumofan Plus Premium, or who have recently stopped taking it, should immediately consult a health care professional,” says Elizabeth Miller, Pharm.D., acting director of FDA’s Division of Non-Prescription Drugs and Health Fraud.

Reumofan Plus and Reumofan Plus Premium are marketed as “natural” dietary supplements for treatment of arthritis, muscle pain, osteoporosis (the thinning of bone tissue and loss of bone density), bone cancer and other conditions. These products are manufactured in Mexico by Riger Naturals and sold widely on the Internet, as well as at flea markets and some retail outlets.

Miller says that the presence of dexamethasone, a corticosteroid, means that people taking these supplements must work with their health care professional to slowly and safely taper off the drug. A person who abruptly stops taking corticosteroids after long-term use or after taking high doses runs the risk of suffering from withdrawal syndrome. This may include nausea, low blood pressure, low blood sugar levels, fever, muscle and joint pain, dizziness and fainting.  

Any of the drug ingredients found in Reumofan Plus or Reumofan Plus Premium can also interact with other medications a consumer may be taking and result in serious health consequences.

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