The FDA is advising consumers not to purchase or use Pro ArthMax, a product promoted and sold as a dietary supplement for joint, muscle and arthritic pain. FDA laboratory analysis confirmed that Pro ArthMax contains the active ingredients diclofenac, ibuprofen, naproxen, indomethacin, nefopam, and chlorzoxazone.
- Diclofenac, ibuprofen, naproxen, and indomethacin are non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage including bleeding, ulceration, and fatal perforation of the stomach and intestines.
- Chlorzoxazone is a muscle relaxant that is only available by prescription. Chlorzoxazone may cause drowsiness, dizziness, and lightheadedness, which may impair the ability to perform certain tasks, such as driving a motor vehicle or operating machinery.
- Nefopam is a non-narcotic pain relieving drug that is not approved for marketing in the U.S. Because nefopam is not FDA-approved, safety or efficacy has not been established. In literature, adverse events such as, rapid heart rate, sweating, dizziness, confusion, hallucinations, and seizures have been reported with nefopam use.
These hidden drug ingredients may interact with other medications and significantly increase the risk of adverse events, particularly when consumers already may be using NSAID-containing products.
Pro ArthMax is labeled in English, but also promoted to the Korean-speaking community. Pro ArthMax is distributed by Human Science Foundation and is sold on various websites and in some retail stores.
Dietary supplements or conventional foods with hidden drugs and chemicals are often represented as being “all natural.” The FDA is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients
See the FDA Public Notification
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication