RECALL UPDATE: Arthritis and Joint Pain Supplements Recalled Due to Undeclared Drugs
According to News Week, Tablets marketed as dietary supplements have been recalled after the U.S. Food and Drug Administration (FDA) discovered three undisclosed drugs in the product. AK Forte, produced by C&A Naturistics, was sold across the U.S. on platforms like Etsy and eBay, claiming to alleviate joint pain and arthritis. However, the product contained dexamethasone, diclofenac, and methocarbamol, necessitating an urgent recall.
Voluntary Recall Announced
C&A Naturistics announced a voluntary recall of all lots of AK Forte on Tuesday, October 8. The FDA followed up with an official announcement on Wednesday, October 16, emphasizing that these tablets should have been regulated as a new drug due to their undisclosed ingredients, which had not undergone the necessary safety and efficacy evaluations.
Potential Health Risks Associated with Ingredients
Dexamethasone
One of the active ingredients, dexamethasone, is a corticosteroid used to treat inflammatory conditions. It can weaken the immune system, making individuals more susceptible to infections and potentially leading to muscle injuries, elevated blood sugar levels, and psychiatric issues. Long-term or high-dose use of corticosteroids can suppress adrenal gland function, affecting hormone production, including cortisol and adrenaline.
Diclofenac
The second drug, diclofenac, is a non-steroidal anti-inflammatory drug (NSAID). Its use may increase the risk of serious cardiovascular events, such as heart attack and stroke, as well as significant damage to the digestive system, including life-threatening conditions like ulcers and perforation of the stomach and intestines.
Methocarbamol
The third ingredient, methocarbamol, is a muscle relaxant that can lead to low blood pressure, dizziness, and sedative effects, potentially impairing the ability to perform tasks requiring focus, such as driving or operating heavy machinery. The FDA has also warned that these drugs may interact adversely with other medications, especially other NSAIDs, leading to serious side effects.
Consumer Advisory
The dietary supplements from C&A Naturistics were marketed to alleviate arthritis and joint pain but contained undeclared drugs. Consumers who have taken AK Forte are strongly encouraged to consult a healthcare professional for advice on safely discontinuing use.
The tablets were sold in boxes of 100 and came in white, blue, red, and gold packaging, featuring a logo with a gold crown above the letters “AK.”
No Reported Health Issues
As of now, there have been no reported adverse health events linked to these tablets. However, individuals who experience health issues potentially connected to AK Forte are advised to contact their physician or healthcare provider promptly.
Return and Disposal Instructions
C&A Naturistics is actively notifying distributors and consumers to facilitate the return of the product. Consumers should return the tablets by calling 619-498-9811 or emailing naturisticsca@gmail.com, or they may choose to discard them. The FDA further recommends that anyone taking AK Forte should seek immediate consultation with their healthcare provider to evaluate withdrawal risks and ensure a safe discontinuation of the product.
