FDA Warns of Hidden Substances in Arthritis, Ache Merchandise

Oct. 24, 2023 – Sure merchandise marketed for arthritis and ache administration might include hidden elements that might hurt customers, in accordance with an FDA warning.

A few of these merchandise have energetic elements present in prescribed drugs. 

“These merchandise might trigger probably severe unwanted side effects and will work together with drugs or dietary dietary supplements a shopper is taking,” the FDA stated in a statement. “It’s clear from the outcomes of our decade of testing that retailers and distributors, together with on-line marketplaces, don’t successfully forestall all these probably dangerous merchandise from being offered to customers.” 

Over 10 years of testing, the FDA identified 22 arthritis and ache merchandise with elements not disclosed on the product label. These hidden elements could be energetic, that means they’ve a direct impact on the physique, or inactive, stated Sweet Tsourounis, PharmD, a professor within the Division of Scientific Pharmacy on the College of California, San Francisco. Ibuprofen, for instance, is the energetic ingredient in Advil. Inactive elements are issues like preservatives, flavoring, and dyes.

Not like prescription remedy and over-the-counter medicine comparable to loratadine (Claritin) or acetaminophen (Tylenol), dietary supplements don’t want FDA approval earlier than they are often offered. The FDA can get entangled solely after a grievance is made or FDA testing reveals unlawful or unsafe elements.

On this investigation, the FDA discovered prescription-only medicine, together with steroids, nonsteroidal anti-inflammatory medicine, and muscle relaxants, in sure dietary supplements, Tsourounis stated.

Kuka Flex Forte and Reumo Flex — each promoted for joint ache and arthritis — each include the NSAID diclofenac. Tapee Tea — a product promoted for ache aid—incorporates the steroid dexamethasone and the NSAID piroxicam. Diclofenac, dexamethasone, and piroxicam are all prescribed drugs. 

“It’s attention-grabbing that these merchandise have hidden elements which can be used to cut back swelling and irritation,” Tsourounis stated. “I don’t know if this was intentional, nevertheless it appears suspicious {that a} product marketed to cut back joint ache and irritation incorporates prescription-only elements which can be used for this goal.”

These kind of drugs can have severe unwanted side effects. Steroids could make the physique much less capable of combat off infections. And in some sufferers, NSAIDs can result in the next threat of stroke or coronary heart assault. Muscle relaxants could cause dizziness and drowsiness, and may make somebody much less capable of do sure duties, like driving or working heavy equipment, Tsourounis stated. These drugs may also work together with different drugs somebody is taking or might trigger allergic reactions. 

These kind of merchandise possible goal underserved and immigrant communities, stated Pieter Cohen, MD, a major care physician and an assistant professor of drugs at Harvard College in Cambridge, MA, who research dietary dietary supplements. They may be offered in mom-and-pop retailers or fuel stations to folks with restricted entry to well being care or insurance coverage, he stated.

Tsourounis advises anybody taking any of the listed merchandise to cease immediately and call their care workforce. They’ll present safer suggestions for managing signs and will counsel testing, like checking kidney operate. Any unwanted side effects or opposed occasions that might be associated to the usage of these merchandise could be reported to FDA’s MedWatch Security Info and Hostile Occasion Reporting Program.

The FDA warned that this list included “solely a small fraction of the possibly harmful merchandise marketed to customers on-line and in shops. Even when a product will not be included on this record, customers ought to train warning earlier than utilizing all these arthritis and ache administration merchandise.” 

To ensure dietary supplements and different over-the-counter merchandise are protected to make use of, Tsourounis beneficial shopping for merchandise from well-known retailers like Goal or giant pharmacies like CVS or Walgreens. Keep away from shopping for merchandise with labels in one other language that you simply can not learn, and be cautious of any product that gives miracle cures or depends on private testimonies with out proof. 

Typically, don’t make purchases based mostly on any well being claims on a product label, as corporations promoting dietary supplements making these claims “don’t should have any scientific information to again them up,” Cohen stated.

Cohen additionally stated you need to persist with particular person elements. “If you would like echinacea, purchase echinacea. Don’t purchase an advanced combine that’s purported to be good for arthritis with 10 totally different botanical [ingredients]. That’s extra prone to run into bother,” he stated. 

Lastly, Cohen beneficial shopping for dietary supplements which can be licensed by the NSF or USP, each revered third-party testing organizations. “If it has an NSF or USP stamp, that provides us extra certainty that what’s within the bottle goes to be what’s listed on label,” he stated. 

Tsourounis famous that in case you are skeptical of a product, you’ll be able to search the FDA’s health fraud database to see if that product reveals up. You may also strive calling the cellphone quantity on the product label. 

“I at all times encourage folks to name that quantity to see if someone solutions,” she stated. “Generally, you’ll be able to inform loads about that firm simply by calling that quantity.”