Our August newsletter about dietary supplements included some cautionary advice about some so-called “natural” supplements that can cause significant harm. One was Reumofan, a product manufactured in Mexico and marketed as a remedy for pain.
The FDA had issued a warning earlier this year about it after receiving several adverse event reports, including stroke, gastrointestinal bleeding, liver problems and worsening glucose control.
Last week, the feds raised the volume of concern about Reumofan after additional reports of bleeding, strokes and even death, according to AboutLawsuits.com.
The warning, “FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium,” says that these products contain drugs that are not declared on the labels. They’re also illicit.
The worrisome active ingredients are dexamethasone, diclofenac, and methocarbamol, a combination whose risk factors include severe injury or death, according to the regulators. Dexamethasone, a corticosteroid, is so powerful that the FDA advises people taking Reumofan products to consult their doctor before they stop using it. It must be discontinued under medical supervision because of a risk of withdrawal syndrome.
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID); methocarbamol is a muscle relaxant. The former can increase the risk of heart attack, stroke and gastrointestinal problems, and the latter can cause dizziness, low blood pressure and compromised mental and physical activity.
It is illegal for products billed as dietary supplements, which are not subject to the same regulatory scrutiny as drugs, to contain FDA-controlled medications.
If you use or recently used any Reumofan product, contact your doctor immediately. If you had a problem after taking Reumofan, contact MedWatch, the FDA’s adverse event reporting program, at (800) 332-1088 or online here.
