A Popular "Natural" Arthritis Supplement Contains Drugs
The FDA says Reumofan Plus has corticosteroid, anti-inflammatory and muscle relaxant ingredients.
Some arthritis patients swear by the effectiveness of the dietary supplements Reumofan Plus and Reumofan Plus Premium, but the U.S. Food and Drug Administration (FDA) says the products actually contain prescription drug ingredients not listed on the label. These active ingredients can be potentially harmful to users, and the FDA is advising consumers using either supplement to see a doctor immediately. One of the chief concerns is the presence of a corticosteroid in Reumofan Plus that, if stopped abruptly, could result in harmful withdrawal symptoms.
In a safety alert, the agency potentially linked use of Reumofan Plus with severe side effects, including death and stroke. Other reported health problems in those using the two products included liver injury, severe bleeding, alterations in blood sugar levels, weight gain, swelling, leg cramps and adrenal suppression.
“[The] FDA has received at least two reports of death and one of stroke in consumers who had used Reumofan Plus,” says Sarah Clark-Lynn, a press officer for the FDA. “Based on the limited information provided in the reports, assessments regarding causality or other contributory factors could not be evaluated.”
The products, manufactured by Riger Naturals, located in Mexico, were sold in retail outlets as well as on popular Internet sites such as eBay and Amazon. They are billed as “100% Natural” and claim to contain ingredients such as white willow, eastern teaberry and Holm oak, as well as vitamins and minerals.
But lab tests on Reumofan Plus found the prescription ingredients dexamethasone, a corticosteroid; diclofenac, a prescription nonsteroidal anti-inflammatory drug; and methocarbamol, a muscle relaxant. Tests on Reumofan Plus Premium found diclofenac and methocarbamol.
Clark-Lynn says the agency first issued a warning about the potential danger of taking Reumofan Plus last June. Around the same time, the FDA reported that Mexican health authorities ordered Riger Naturals to recall the product. One distributor in the U.S. also issued a recall. But there still may be bottles of the product out there.
“Because this product is manufactured by a company in Mexico and distributed by a large number of small distributors in the United States, it is extremely difficult for [the] FDA to address all distributors that may be selling this product at retail and on the internet,” says Clark-Lynn.
One pharmacy expert says the finding of drug-tainted supplements is not all that surprising. “When you buy a natural product, it’s kind of like the wild, wild west,” says pharmacist C. Michael White, professor and head of the department of pharmacy practice at the University of Connecticut, in Storrs, who says the FDA’s regulatory authority over supplements is limited. “With natural products, the onus is on the FDA to prove that the products don’t meet purity standards, that the ingredients inside those products are unsafe,” says White.
That is in contrast to the way FDA regulates over-the-counter and prescription medications: the manufacturer – and not the FDA – has to prove purity and safety beforethe drug hits the market. “It’s like an alternate universe for the FDA,” White says.
Natural product experts say the red flags for the two Reumofan products should have gone up for consumers long before. For example, White says, using a supplement containing more than a few ingredients is asking for trouble, because it’s more likely those ingredients have not been studied to see if they interact with each other. Labeling for the Reumofan line indicates they contain more than a dozen ingredients, including plant products, vitamins and minerals.
Pharmacist Lana Dvorkin Camiel, director of Applied Natural Products Programs at the Massachusetts College of Pharmacy and Health Sciences in Boston, says it’s also crucial to know who is making the product. “Every time something like this comes out it creates a strong reminder to the consumer that reputation of the manufacturer is the No. 1 priority,” she says.
Dvorkin Camiel says tainted supplement cases highlight a sad irony. “Patients considering taking these supplements are looking for a safer alternative,” she says. “And so when we see these cases, it’s surprising – and it certainly doesn’t do anything for the dietary supplement industry.”
A 2006 survey by the Natural Products Foundation – the research and education arm of the Natural Products Association, a trade group – found the dietary supplement industry contributed $61 billion to the U.S. economy. But it has a reputation for not always being above-board with consumers. In recent years, the FDA says it has flagged hundreds of tainted dietary supplements, including some that have been shown to cause harm. The three most common categories of tainted supplements include weight-loss, body-building and sexual enhancement products.
“It’s very frustrating,” says Dvorkin Camiel. “Cases like this destroy the reputation that is being built. It overshadows the whole industry.”
White says there are ways consumers can protect themselves. For one thing, he recommends individual-ingredient products. Also, he says look for the USP, or United States Pharmacopeia, seal. This guarantees that what’s on the label is in the bottle, in the amounts specified for each dose, that the product does not contain harmful levels of contaminants, and that it was manufactured in an acceptable, sanitary way. And he recommends only buying products from U.S. manufacturers.
Dvorkin Camiel says it’s also important to get professional help. “Communicate with your health care provider, talk with your pharmacist, your naturopathic physician. Don’t necessarily choose a product yourself,” she says.