FDA: All-natural dietary supplement Reumofan Plus contains prescription drugs

11-Jun-2012 - Last updated on 12-Jun-2012 at 15:40 GMT

Reumofan Plus is marketed as a '100% all natural dietary supplement' but in fact contains prescription drugs, says the FDA

Lab tests on Reumofan Plus, a dietary supplement made in Mexico and marketed as a natural pain reliever, show that it contains at least two prescription painkillers, the Food and Drug Administration (FDA) has warned.

An FDA laboratory analysis of the product - described on websites such as reumofan-plus.org as a “100% all natural dietary supplement” containing Eastern Teaberry, White Willow and Curcumin - revealed that it also contained the prescription drugs Diclofenac Sodium (a non-steroidal anti-inflammatory) and Methocarbamol (a muscle relaxant).

Diclofenac Sodium, Methocarbamol and Dexamethasone

These active pharmaceutical ingredients may cause increased risk of heart attack and stroke, gastrointestinal bleeding and ulceration (Diclofenac sodium) and dizziness, drowsiness and low blood pressure (Methocarbamol), claimed the FDA.

Multiple AERs

Meanwhile, the Mexican Ministry of Health has also discovered that “at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant”, said the agency.

“FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression."

Product recall

Labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions, Reumofan Plus is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites, said the FDA.

“FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.”

Active pharmaceutical ingredients

While there is no hard data to suggest that the spiking of dietary supplements with unauthorized active pharmaceutical ingredients (APIs) is a growing problem, it has become a talking point this year following a Dr Oz episode devoted to it in January.

Speaking to NutraIngredients-USA after the show aired, James Neal-Kababick, director of Oregon-based lab Flora Research Laboratories, said that some of it was deliberate spiking, and some of it was inadvertent contamination.

He added: “We’re seeing more deliberate spiking with high levels of APIs but also more samples with low level contamination.”

Sloppy manufacturing

In the latter case, this might be due to manufacturers producing supplements in facilities that are also licensed to produce drugs, or where manufacturers are making counterfeit drugs and then producing ingredients or dietary supplements out of the same facility, he said.

“Some of these companies use compressed air to clean up kit between batches – which can leave residues - instead of properly washing down the facility and then validating the cleaning as per pharmaceutical standards.

“I’d say that this low level contamination is a more recent phenomenon and it concerns me, because it is sloppy manufacturing.”

He added: “What is also worrying is that while most of the spiking is in weight loss, sports and male virility products, we’re also seeing more in anti-diabetic blood sugar support products, where we have detected anti-psychotic and blood pressure meds.”