May 18, 2022

FDA Issues Warning for Consumer Products with Hidden Pain Medications

The FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to potentially dangerous hidden active drug ingredients not listed on the product label.

These products are marketed as treatments for arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. These medications are sold on various websites and in some retail stores, and it is possible certain injured workers may have purchased them to help manage pain.

FDA laboratory analysis revealed certain Artri and Ortiga products contained undeclared dexamethasone, diclofenac sodium, and methocarbamol, all which come with safety risks when not used appropriately. Furthermore, these drugs can interact with an individual’s overall drug regimen, leading to additional safety concerns, including drug-drug or drug-disease interactions.

Dexamethasone, a corticosteroid used to treat inflammation, can cause serious adverse events such as infections, increased blood sugar levels, changes in blood pressure, bone damage, psychiatric problems, and adrenal dysfunction

Diclofenac sodium, an anti-inflammatory drug, can cause adverse cardiovascular events, such as heart attack and stroke, or serious gastrointestinal damage, including bleeding, ulceration, and fatal tears of the stomach and intestines, or liver toxicity including liver failure that can cause the need for a liver transplant or death.

Methocarbamol (a muscle relaxant) can cause sedation, dizziness, and low blood pressure.

FDA has received adverse event reports, including reports of liver toxicity and death, associated with the use of Artri King products, since the agency issued its first warning about an Artri Ajo King product on January 5, 2022.

Health care professionals should evaluate patients who have used Artri and Ortiga products for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and treat accordingly. The FDA urges consumers taking these products to immediately talk to their health care professional to safely discontinue use of the product because suddenly stopping these drugs may be dangerous.

For an up-to-date, interactive view of drug approvals and safety alerts impacting workers’ comp, visit Healthe’s MedMonitor website.

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