Arthritis Supplement Recalled Due to Undeclared Drug Ingredients
FDA analysis found Super Arthgold is contaminated with several drugs that could cause adverse reactions, potentially fatal.
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.”
The muscle relaxant chlorzoxazone (prescription brand name Lorzone) “is probably the least dangerous,” says Miller. “It may cause some dizziness.” It also can interact with other medications, and it is not recommended for the elderly.
Anthony Kwak, the director of sales for Nano Well-being Health, says that his company ships the product’s raw ingredients to a second company, Human Science Foundation in Gardena, Calif., that produces the capsules, and it was there that the mix-up occurred.
In fact, in January, Human Science Foundation issued a voluntary recall of another product, Pro ArthMax, after FDA testing found undeclared drug ingredients, including chlorzoxazone, diclofenac and indomethacin – the three drugs later found in Super Arthgold.
This turned the spotlight on Super Arthgold. “We give them our ingredients and they [Human Science Foundation] put some other, unknown ingredients in it,” says Kwak. “We found [Super Arthgold] has some active ingredients, so we started the [voluntary] recall last January. The FDA got involved in April,” says Kwak. “We are the victims, too.”
Super Arthgold was sold nationwide in bottles containing 120 capsules. The two lots affected are:
L1P1-6100/Expiration date June 25, 2016
L1P2-6000/Expiration date September 16, 2016
Kwak says that about 2,000 bottles were sold to retailers, such as health food stores. Although Kwak says Nano Well-being Health does not market Super Arthgold on the Internet, bottles of it had been (but are no longer) available on Amazon.com.
Consumers who have products from those lots should not take any more of the supplement and should return it to the place of purchase. Those with questions regarding this recall can contact Nano Well-being Health Inc. at the number printed on the label, 888/524-5114 or 714/515-4600, or by emailing firstname.lastname@example.org. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to this product. Those consumers also should file a report with the FDA’s MedWatch Adverse Event Reporting Program. (Click on the link to fill out a report online or call 800/332-1088.)
The problem of supplements containing undeclared drug ingredients is not new – nor is it likely to end soon, says Miller, a pharmacist specializing in arthritis medications. “This is a continuing potential problem because supplements are regulated by the FDA, but loosely. The FDA only has authority to step in if it finds safety or contamination problems,” he says. The FDA does not approve supplements, as it does medications, nor does it actively inspect them unless it is alerted to a problem.
“This is especially a problem, because people take these products because they don’t trust prescription medications,” he adds.
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