Pro ArthMax, marketed as a dietary supplement for joint pain and arthritis, is being recalled because it contains a number of undeclared pharmaceuticals that have “a reasonable probability of resulting in fatal adverse events in consumers and patients with underlying illnesses,” according to the supplement’s maker, Human Science Foundation, of Gardena, CA. Consumers who have purchased this product should not use it.
The recalled product was labeled as a dietary supplement and sold in 120-count bottles. An analysis by the U.S. Food and Drug Administration (FDA) revealed that it contains a number of undeclared pharmaceuticals, making it an unapproved new drug. The unlisted drugs include: 2.4mg of Chlorzoxazone, 0.78mg of Nefopam, 2.5mg of Diclofenac, 7.7mg of Ibuprofen, 2.1mg of Naproxen, and 1.9mg of Indomethacin.
Consumers with allergies to those ingredients, or with underlying cardiac, gastrointestinal, liver, and renal conditions, or who are recovering from cardiac bypass graft surgery risk life-threatening illness or death from use of this product.
Consumers who take Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or other pain relievers for arthritis and joint pain risk overdose from use of this product as they would not be aware that the recalled product contains NSAIDs and other drugs. Adverse health events linked to NSAID overdosing include: myocardial infarction, stroke, congestive heart failure, renal toxicity, and bleeding, ulceration, or perforation of the stomach or intestines.
If you have had an adverse health event associated with the use of this product, report it to the FDA by clicking here. The agency is gathering information on supplements, which are regulated by the FDA, but fall under the umbrella of food, not drugs. Therefore, they are not subject to pre-market evaluation by the agency.
