Recall Alert: Arthritis Supplements Found Containing Undeclared Drugs

According to News Week, The U.S. Food and Drug Administration (FDA) has announced that AK Forte, a dietary supplement produced by C&A Naturistics, should not have been sold as such after it was found to contain three undeclared drugs. The product, marketed for joint pain and arthritis relief, contained dexamethasone, diclofenac, and methocarbamol.

Recall Announcement

C&A Naturistics voluntarily recalled all lots of AK Forte on Tuesday, October 8, 2024. The FDA confirmed the recall on Wednesday, October 16, emphasizing that the tablets should have been regulated as a new drug, as they did not undergo the necessary processes to ensure safety and efficacy.

The Risks of Dexamethasone

One of the active ingredients in AK Forte is dexamethasone, a corticosteroid used to treat inflammatory conditions. While effective, dexamethasone can impair the immune system, making individuals more susceptible to infections. Prolonged use or high doses can lead to serious health issues, including:

• Muscle injuries
• Elevated blood sugar levels
• Psychiatric problems
• Suppression of the adrenal gland, which produces essential hormones like cortisol and adrenaline

Dangers of Diclofenac

Another ingredient, diclofenac, is a non-steroidal anti-inflammatory drug (NSAID). It carries risks such as:

• Increased likelihood of heart attack and stroke
• Severe damage to the digestive system, potentially resulting in bleeding, ulcers, and perforation of the stomach and intestines, which can be fatal

Concerns About Methocarbamol

The third undeclared drug, methocarbamol, is a muscle relaxant that can cause:

• Low blood pressure
• Dizziness
• Sedative effects

These side effects can hinder a person’s ability to perform certain tasks safely, such as driving or operating heavy machinery.

Interaction Warnings

The FDA has cautioned that the drugs found in AK Forte could interact with other medications, leading to serious side effects, particularly for individuals taking other NSAIDs.

Consumer Guidance

Consumers who have taken AK Forte are urged to consult with a healthcare professional about how to discontinue use safely. The tablets were sold in boxes of 100, featuring white, blue, red, and gold packaging with a logo of a gold crown above the letters “AK.”

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Health Monitoring and Reporting

To date, no negative health events have been reported in connection with AK Forte. However, anyone experiencing adverse effects related to the product should contact their physician or healthcare provider immediately.

Return Instructions

C&A Naturistics is actively notifying distributors and consumers to facilitate returns. Consumers can return the tablets by calling 619-498-9811 or emailing naturisticsca@gmail.com. Alternatively, they can safely discard the product.

The FDA strongly recommends that consumers taking AK Forte consult with their healthcare provider for an assessment of withdrawal risks and guidance on safely stopping use of the tablets.