Supplement Laced with Harmful Meds | Body Health & Fitness

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The FDA issued a warning to consumers against using a a Mexican ?natural? dietary supplement promoted for pain relief due to unlabeled and potentially harmful pharmaceutical ingredients.

The warning for Reumofan Plus was issued after the agency received a number of adverse event reports, including incidences of liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression.

After a laboratory analysis, the agency found Reumofan Plus contains the prescription drugs diclofenac sodium and methocarbamol.

Diclofenac sodium is a nonsteroidal anti-inflammatory drug that may cause cardiovascular events such as heart attack and stroke as well as serious gastrointestinal adverse events including bleeding, ulceration, and fatal perforation of the stomach and intestines, the FDA said in a statement.

Methocarbamol is a muscle relaxant that can cause sedation, dizziness, hypotension and can impair mental and physical performance to drive or operate machinery.

Additional analysis by the Mexican Ministry of Health uncovered that at least one lot of the product contained the corticosteroid dexamethasone, which acts as an anti-inflammatory and immune system suppressant.

The Mexican Ministry of Health ordered the manufacturer, Riger Naturals, to recall the product and has issued a health warning to the public.

The FDA warned that these unlabeled components of Reumofan Plus may put patients taking other medications at risk for adverse drug interactions.

It cautioned that patients taking corticosteroids may be at risk for fatigue, nausea, hypotension, low blood sugar levels, fever, muscle and joint pain, and fainting if they discontinue Reumofan Plus use abruptly after prolonged or high-dose exposure.

The agency added that healthcare professionals are urged to ask patients about use of Reumofan Plus ? or other products marketed as dietary supplements ? if they present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids.

?Healthcare professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus,? the FDA stated.

The product is labeled in Spanish and marketed as a treatment for arthritis, muscle pain, osteoporosis, bone cancer, and other conditions, the statement said. It is sold at retail outlets, flea markets, and through online distributors.

Patients using, or who have recently used, Reumofan Plus should immediately consult a healthcare professional.

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Cole Petrochko

Associate Staff Writer

Cole Petrochko started his journalism career at MedPage Today in 2009, after graduating from New York University with B.A.s in Journalism and Psychology. When not writing for MedPage Today, he blogs about nerd culture, designs websites, and buys and sells collectible card game cards. He is based out of MedPage Today?s Little Falls, N.J. Headquarters.

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