Certain products marketed for arthritis and pain management could contain hidden ingredients that could be harmful to consumers, according to a warning by the US Food and Drug Administration (FDA).
Some of these products contain active ingredients found in anti-inflammatory prescription medication.
“These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking,” the FDA said in a statement. “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers.”
Unlike prescription medication and over-the-counter drugs such as loratadine (Claritin) or acetaminophen (Tylenol), supplements do not need FDA approval before they can be sold. Only after a complaint is made or FDA testing reveals illegal or unsafe ingredients can the FDA get involved.
Dr Candy Tsourounis
From August 2013 to September 2023, the FDA identified 22 arthritis and pain products with active ingredients not disclosed on the product label. The most common hidden ingredients detected in these supplements were prescription-only corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and muscle relaxants, said Candy Tsourounis, PharmD, a professor in the department of clinical pharmacy at the University of California, San Francisco.
Kuka Flex Forte and Reumo Flex, both promoted for joint pain and arthritis, both contain the NSAID diclofenac. Tapee Tea, a product promoted for pain relief, contains dexamethasone and piroxicam. AK Forte, also sold for joint pain and arthritis, contains diclofenac, dexamethasone, and methocarbamol not disclosed on the label.
“It is interesting that these products have hidden ingredients that are used to reduce swelling and inflammation,” Tsourounis said. “I don’t know if this was intentional, but it seems suspicious that a product marketed to reduce joint pain and inflammation contains prescription-only ingredients that are used for this purpose.”
Certain products also contained antihistamines including cyproheptadine and chlorpheniramine.
Dr Pieter Cohen
These types of products are likely targeted toward underserved and immigrant communities, added Pieter Cohen, MD, a primary care physician and an assistant professor of medicine at Harvard University in Cambridge, Massachusetts, who studies dietary supplements. They might be sold in mom-and-pop shops or gas stations to individuals with limited access to healthcare or insurance, he noted.
The FDA warned that this list included “only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of arthritis and pain management products.”
Advising Patients
Research suggests that most patients do not tell doctors about the supplements they are taking, and often, clinicians do not ask, said Cohen. “Most of the time it’s a total black box – we don’t know what’s going on,” he added.
He advised raising the subject of supplements in a very nonjudgmental way, particularly when treating patients in marginalized and immigrant communities. One approach he suggested was first mentioning that other patients in your care dealing with joint pain have bought remedies locally or have tried treatments that friends recommend. You can then ask a patient about their own use, framing it as a way to better help with treatment decisions.
Once a clinician understands what their patient is taking, they can then give advice and discuss if a product is safe to combine with prescription drugs, Cohen said. “If they come down too hard, I think the patients will just clam up and not talk about it anymore,” he said.
If a patient begins to experience side effects or gets sick, a clinician will already be informed in what their patient is taking can ask that patient to bring the product or supplement in, so they can look over the product together, Cohen noted. Any side effects or other adverse events potentially related to the use of these products should then be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Tips for Safe Shopping
To make sure supplements and other over-the-counter products are safe to use, Tsourounis recommends that consumers:
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Buy products from well-known retailers like Target or large pharmacies like CVS or Walgreens.
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Avoid buying products with labels in another language that you cannot read or products with no drug label.
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Be cautious of buying products online or from other countries.
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Look up suspicious products on the FDA’s health fraud database.
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Be wary of any product that offers miracle cures or relies on personal testimonies without evidence.
In general, do not base purchasing decisions on any health claims on a product label because companies selling supplements making these claims “don’t have to have any clinical data to back them up,” Cohen said.
Cohen also recommending sticking with individual ingredients. “If you want echinacea, buy echinacea. Don’t buy a complicated mix that is supposed to be good for arthritis with 10 different botanical [ingredients]. That’s more likely to run [you] into trouble,” he said.
Last, Cohen recommended buying supplements that are certified by NSF International or United States Pharmacopeia, both respected third-party testing organizations. “If it has an NSF International or USP stamp, that gives us more certainty that what’s in the bottle is going to be what’s listed on label,” he said.
Tsourounis noted that if you are skeptical of a product, you can also try calling the manufacturer number on the product label.
“I always encourage people to call that number to see if somebody answers,” she said. “Sometimes, you can tell a lot about that company just by calling that number.”
Cohen has received research support from the Consumers Union and PEW Charitable Trusts and royalties from UpToDate. He has collaborated in research with NSF International. Tsourounis disclosed no relevant financial relationships.
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