California-based Nano Well-being Health, Inc., has issued a voluntary recall for Super Arthgold (500 mg) – a dietary supplement marketed for joint pain and arthritis – after testing by the U.S. Food and Drug Administration (FDA) found it contained undeclared drug ingredients, making it an unapproved new drug.

The supplement is billed as an “all-natural source formula.” Among the ingredients listed on the label are the organic compound MSM, the popular Chinese herb Angelica sinensis (also known as dong quai) and white peony root.

The drug ingredients found in the supplement but not listed on the label are the prescription muscle relaxant chlorzoxazone and two prescription nonsteroidal anti-inflammatory drugs (NSAIDs), diclofenac and indomethacin.

According to a press release issued by the FDA:

“Use of this product containing undeclared drug ingredients has a reasonable probability of resulting in fatal adverse events in consumers and patients with underlying illnesses, including known allergy to the hidden ingredients, cardiac, gastrointestinal, hepatic [liver], and renal [kidney] conditions as well as patients who recently [have] undergone cardiac bypass graft surgery.”

NSAIDs – including ibuprofen, naproxen, diclofenac, etodolac, meloxicam and indomethacin – are among the most commonly used drugs to reduce arthritis-related pain and inflammation. Various NSAIDs are the active ingredients in many prescription and over-the-counter products, including Aleve, Advil, Arthrotec, Indocin, Mobic and Voltaren XR – none of which are involved in the recall. But NSAID use has been linked to gastrointestinal (GI) bleeding and elevated risk of cardiovascular events, such as heart attack and stroke. 

The hidden NSAIDs in Super Arthgold are problematic for at least two reasons. Consumers who should not take NSAIDs – including those who have or are at risk for heart disease and GI problems – may believe Super Arthgold is a safe substitute and take it, inadvertently getting the drug they were seeking to avoid. Secondly, because consumers are not aware that Super Arthgold contains NSAIDs, they may accidentally overdose by taking another medication that also contains an NSAID, which could put them at greater risk for adverse events.  

“The diclofenac and indomethacin [in Super Arthgold] may cause gastrointestinal upset or bleeding, heart attack, stroke, kidney problems. It’s quite an issue for those already at risk of those problems,” says Donald Miller, PharmD, professor and chair of pharmacy practice at North Dakota State University, in Fargo. “Generally, in an older population, they are definitely at risk of all those issues.”