FDA Warns of Hidden Ingredients in Arthritis, Pain Products

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

A few of these merchandise have energetic elements present in pharmaceuticals. 

“These merchandise could trigger probably critical uncomfortable side effects and should work together with drugs or dietary dietary supplements a client 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 stop all these probably dangerous merchandise from being bought 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, which means they’ve a direct impact on the physique, or inactive, stated Sweet Tsourounis, PharmD, a professor within the Division of Medical 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.

In contrast to prescription treatment and over-the-counter medication equivalent to loratadine (Claritin) or acetaminophen (Tylenol), dietary supplements don’t want FDA approval earlier than they are often bought. The FDA can get entangled solely after a criticism is made or FDA testing reveals unlawful or unsafe elements.

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

Kuka Flex Forte and Reumo Flex – that are promoted for joint ache and arthritis – each comprise the NSAID diclofenac. Tapee Tea – a product promoted for ache reduction – comprises the steroid prednisone 21-acetate and the NSAID piroxicam. Diclofenac and piroxicam are pharmaceuticals. 

“It’s fascinating that these merchandise have hidden elements which are used to scale back swelling and irritation,” Tsourounis stated. “I don’t know if this was intentional, nevertheless it appears suspicious {that a} product marketed to scale back joint ache and irritation comprises prescription-only elements which are used for this objective.”

Most of these drugs can have critical uncomfortable side effects. Steroids could make the physique much less capable of battle off infections. And in some sufferers, NSAIDs can result in a better 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 work together with different drugs somebody is taking or could trigger allergic reactions. 

Most of these merchandise doubtless goal underserved and immigrant communities, stated Pieter Cohen, MD, a main care physician and an assistant professor of drugs at Harvard College in Cambridge, MA, who research dietary dietary supplements. They may be bought in mom-and-pop outlets or gasoline stations to individuals 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 get in touch with their care workforce. They’ll present safer suggestions for managing signs and should recommend testing, like checking kidney perform. Any uncomfortable 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 Adversarial Occasion Reporting Program.

The FDA warned that this list included “solely a small fraction of the doubtless 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 secure to make use of, Tsourounis advisable 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 just can not learn, and be cautious of any product that gives miracle cures or depends on private testimonies with out proof. 

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

Cohen additionally stated it is best to keep on with particular person elements. “If you need echinacea, purchase echinacea. Don’t purchase an advanced combine that’s alleged to be good for arthritis with 10 totally different botanical [ingredients]. That’s extra more likely to run into hassle,” he stated. 

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

Tsourounis famous that if you’re skeptical of a product, you possibly can search the FDA’s health fraud database to see if that product exhibits up. You can too attempt calling the cellphone quantity on the product label. 

“I at all times encourage individuals to name that quantity to see if any person solutions,” she stated. “Typically, you possibly can inform so much about that firm simply by calling that quantity.”

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