FDA Issues Recall for Joint Pain Supplements Over Undisclosed Medications
According to News Week, The U.S. Food and Drug Administration (FDA) has announced a recall of AK Forte, a product marketed as a dietary supplement for joint pain and arthritis, after it was found to contain three undeclared drugs.
Details of the Recall
C&A Naturistics, the producer of AK Forte, voluntarily recalled all lots of the product on Tuesday, October 8, 2023. The recall was made public by the FDA on Wednesday, October 16, 2023, which clarified that the tablets should have been regulated as a new drug but had not undergone the necessary safety and efficacy evaluations.
Undeclared Drugs Found in AK Forte
The recalled AK Forte tablets contain the following drugs:
- Dexamethasone: A corticosteroid used to treat inflammatory conditions. It can impair the immune system, increase the risk of muscle injuries, raise blood sugar levels, and lead to psychiatric issues. Long-term or high-dose use can suppress adrenal gland function, impacting the production of essential hormones such as cortisol and adrenaline.
- Diclofenac: A non-steroidal anti-inflammatory drug (NSAID) that may heighten the risk of heart attack and stroke. It can also cause serious gastrointestinal damage, including bleeding, ulcers, and perforation of the stomach and intestines, which can be fatal.
- Methocarbamol: A muscle relaxant that may cause low blood pressure, dizziness, and sedation. This drug can impair the ability to perform tasks requiring alertness, such as driving or operating heavy machinery.
Health Risks and Interactions
The FDA has warned that these undeclared drugs can interact with other medications, potentially leading to serious side effects, especially for individuals taking other NSAIDs.
Consumer Advisory
C&A Naturistics has begun notifying distributors and consumers to facilitate the return of the affected products. Consumers who have taken AK Forte are urged to consult with their healthcare professionals about safely discontinuing use.
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The AK Forte tablets are packaged in boxes containing 100 tablets, featuring white, blue, red, and gold cardboard packaging with a logo depicting a gold crown above the letters “AK.”
No Reports of Adverse Health Events
As of now, there have been no reported negative health events linked to the use of AK Forte. However, anyone experiencing health issues that may be associated with the product should contact their physician or healthcare provider.
How to Return the Product
Consumers can return the recalled tablets by calling C&A Naturistics at 619-498-9811 or by emailing naturisticsca@gmail.com. Alternatively, they are advised to safely discard the product.
The FDA strongly recommends that consumers taking AK Forte consult with their healthcare providers to assess any withdrawal risks and to ensure a safe discontinuation of the tablets.
