Tablets sold as dietary supplements should not have been, according to the U.S. Food and Drug Administration (FDA), after three drugs were found in the product.
AK Forte, produced by C&A Naturistics, were sold throughout the U.S. on Etsy and eBay as supplements for joint pain and arthritis, but contained drugs: dexamethasone, diclofenac and methocarbamol.
All lots of this product are being recalled voluntarily by C&A Naturistics, as announced by the company on Tuesday, October 8.
The FDA announced the recall on Wednesday, October 16, specifying that the tablets should have been regulated as a new drug but did not go through processes necessary to ensure safety and efficacy.
One of the drugs that these tablets contain is dexamethasone: a type of drug called a corticosteroid, used to treat inflammatory conditions. It can impair a person’s ability to fight infections, and can lead to muscle injuries, high blood sugar levels, and psychiatric problems.
When taken for a long period of time or at high doses, corticosteroids such as dexamethasone can suppress the adrenal gland, responsible for producing and releasing essential hormones such as cortisol and adrenaline.
Diclofenac is another of the three drugs contained in AK Forte. It is a non-steroidal anti-inflammatory drug (NSAID), which may increase a person’s risk of heart attack and stroke, and of serious damage to the digestive system, including bleeding, ulcers and perforation of the stomach and intestines, which can be fatal.
The third drug used in AK Forte is methacarbamol: a muscle relaxant that can cause low blood pressure, dizziness, and a sedative effect. Methocarbamol can prevent someone from performing certain tasks safely, such as driving a car or operating heavy machinery.
The FDA has also warned that these drugs could interact with other medications, causing serious side effects, especially if an individual is taking other NSAIDs.
The AK Forte tablets were sold as boxes of 100 tablets, with white, blue, red and gold cardboard packaging, and a logo that depicted a gold crown above the letters “AK.”
To date, there have been no reports of negative health events related to these tablets, but anyone who does experience problems that might be connected, should contact their physician or healthcare provider.
C&A Naturistics has been notifying distributors and consumers to arrange for returns, and consumers are being advised to return the tablets—by calling 619-498-9811 or emailing naturisticsca@gmail.com—or discard them.
The FDA has advised that consumers taking AK Forte should immediately consult with their healthcare provider to be assessed for withdrawal risks and to safely stop using the tablets.
Newsweek has approached C&A Naturistics for comment.
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