Non-FDA approved medication and gout

A family member recently asked me about this new herbal supplement, which I had never heard of, that supposedly stops gout attacks in an instant. Since I have never heard of it, I decided to look it up on reliable sources such as PubMed, Lexi-Comp, UpToDate, and Natural Medicines Comprehensive Database and found nothing. It turns out that this supplement is not approved by the U.S. Food and Drug Administration. This article will discuss background information on gout, FDA approved medication options, and the non-FDA approved drug in question that you can discuss with your healthcare provider and pharmacist.

In patients with gout, we see an overproduction or under excretion of a chemical called uric acid. Clinical presentation of gout in the early stages typically feature an acute inflammation of any joint (typically the big toe) such as ankles, heels, knees, wrists, fingers, and elbows. Later stages feature an increase in uric acid resulting in flares, more than one joint being affected, tophi (due to crystal deposits), kidney stones, and renal failure.

To treat an acute attack, the current guidelines from the American College of Rheumatology suggest both non-medication and medication options that acutely treat pain and decrease inflammation (do not target pathophysiology). If you do not have access to the recommended medications and the pain is very mild, you can apply an ice pack on the affected area. For mild/moderate acute gout attacks, monotherapy is recommended with NSAIDs (indomethacin, naproxen, and sulindac are FDA-approved to treat acute gout), colchicine, and corticosteroids (prednisone and methylprednisolone are typically used).

To prevent recurrent attacks, typically in those who experience more than two gout attacks per year, urate-lowering therapy is recommended. ULT medications include allopurinol, febuxostat, or probenecid (if you cannot take febuxostat or allopurinol), which help decrease the amount of uric acid in your body.

The non-FDA approved drug/supplement in question claims on the packaging that it is an herbal supplement that “soothes achy joint, relieves pain, longevity joint strength, and liver detoxification.” One website that sells the product claims that it “cures high uric acid, arthritis, and gout.” According to the FDA, a product sold as a dietary supplement (herbal products are considered dietary supplements per FDA) and promoted on its label or labeling as a “treatment, prevention or cure for a specific disease or condition would be considered an unapproved—and therefore illegal—drug.” In 2015, even the Philippines FDA issued a warning against using it, as it posed “potential danger or injury.” In addition, the ingredients are not listed on its packaging box nor on any website so we do not even know what are the contents in each capsule but can only assume that it is not 100 percent herbal, as many supplements contain prescription medications not mentioned on their labels.

Gout is a condition due to overproduction or under excretion of uric acid. The approved therapy for acute gout attacks can be treated with NSAIDs, colchicine, and corticosteroids. For those that experience more than two attacks per year, there are medications that target the pathophysiology of gout. Due to the non-FDA approved medication’s time of onset almost being immediate in treating an acute gout attack, many have vouched for it and tell their family and friends about it. However, this herbal supplement is not approved in treating gout, with its claims even being illegal per the FDA. Before starting any new medication or supplement, seek medical advice from your healthcare provider or pharmacist to ensure that your treatment is both safe and effective.

References:
1. Khanna D, Fitzgerald JD, Khanna PP, et al. 2012 American College of Rheumatology guidelines for management of gout.

Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia.

Arthritis Care Res (Hoboken). 2012;64(10):1431-46.

2. Khanna D, Khanna PP, Fitzgerald JD, et al. 2012 American College of Rheumatology guidelines for management of gout.

Part 2: therapy and anti-inflammatory prophylaxis of acute gouty arthritis. Arthritis Care Res (Hoboken). 2012;64(10):1447-61

3. Questions and answers on dietary supplements. Available at: https://www.fda.gov/food/dietarysupplements/usingdietarysupplements/ucm480069.htm#legal_market. Accessed May 29, 2017.

4. Public health warning against the use of the following unregistered drug products. Available at: http://www.fda.gov.ph/attachments/article/250255/FDA%20Advisory%20No.%202015-035.pdf. Accessed May 29, 2017.

JONATHAN MUNA (Special to the Saipan Tribune)
Jonathan Muna, PharmD, was raised on Saipan and is a graduate of the University of Hawaii at Hilo Daniel K. Inouye College of Pharmacy, who received his Doctor of Pharmacy degree in 2017. His interests include infectious disease and ambulatory care.