The Food and Drug Administration (FDA) has issued a warning for consumers not to use or purchase products sold under variations of the names Artri (such as Artri Ajo King and Artri King) or Ortiga (such as Ortiga Mas Ajo Rey and Ortiga Mas Ajo Rey Extra Forte), as these products may contain potentially dangerous active drug ingredients that are not listed on the labeling. The ingredients include dexamethasone (a corticosteroid), diclofenac sodium (a nonsteroidal antiinflammatory drug), and methocarbamol (a muscle relaxer). The products are promoted as treatments for arthritis, muscle pain, osteoporosis, and bone cancer, among other conditions, and can be purchased online through various websites, such as Amazon and Walmart, as well as on Etsy, eBay, and natural health sites that promote dietary supplements. It should be noted that following the April 22 FDA consumer warning concerning these products, Amazon and Walmart stopped featuring them on their sites.
Dexamethasone is known to increase the risk of infections, hyperglycemia, hypertension, visual changes, changes in mood or thought, osteoporosis, and adrenal insufficiency, especially with long-term use. Diclofenac sodium is known to increase the risk of cardiovascular events, such as heart attack and stroke; serious gastrointestinal damage, including bleeding, ulceration, and fatal tears in the stomach and intestines; and liver toxicity or failure, which can require a liver transplant or lead to death. Methocarbamol can cause sedation, dizziness, and low blood pressure. These adverse effects can occur when these active ingredients are added to Artri or Ortiga products.
If nurses or other providers determine that a patient has an adverse effect from one of these products, they should notify the FDA's MedWatch program at http://www.fda.gov/medwatch/report.htm. Depending on how long the patient has been using the product, withdrawal may need to be slow to prevent complications.
When conducting a thorough drug history with patients, nurses and NPs should ask about the use of these products and all over-the-counter (OTC) products. Nurses and NPs should educate patients on how to safely buy pharmaceutical products, especially over the internet. Patient resources on the use of OTC medications can be found at http://www.fda.gov/drugs/buying-using-medicine-safely/understanding-over-counter. Tips on how to buy drugs safely online can be found at http://www.fda.gov/consumers/consumer-updates/how-buy-medicines-safely-online-ph.
To read the FDA News Release about these products, go to http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-pu.