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FDA issues warning on supplement Reumofan Plus due to presence of pharmaceutical drugs

Filed June 6th, 2012 Laurie

The Food and Drug Administration has issued a public safety alert on a dietary supplement marketed as “natural” because tests have shown that it contains as many as two different pharmaceutical agents.

According to a release from the agency, which follows a recall issued by health officials in Mexico, Reumofan Plus should be avoided and anyone that recently used it or stopped using it should contact a physician if they suspect it could have caused them injuries.

Reumofan Plus is marketed and labeled in Spanish and is marketed as a supplement used in the treatment of arthritis, muscle pain, osteoporosis, bone cancer, and other conditions, according to the FDA’s release. The product is manufactured by Riger Naturals and sold through several retailers.

Along with Mexican authorities, the FDA has received reports of consumers who’ve suffered sudden and unexpected side effects while taking Reumofan, including liver injury, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps, and adrenal suppression (problems with kidney functioning).

According to the release, the supplement contains but does not label diclofenac sodium, a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines. It also contains methocarbamol, a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.

The FDA considers supplements containing prescription drug products to be adulterated and unsafe. If a company wishes to market these products, it would have to prove through unbiased scientific evidence that it is safe. Because these drugs are not on the labels, people taking other drugs that could interact with those in the supplement are more likely to suffer serious injuries from taking it.

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