Methocarbamol (a muscle relaxant) that can cause sedation, dizziness, and low blood pressure.Diclofenac sodium (an anti-inflammatory drug) that can lead to 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.Dexamethasone (a corticosteroid) that can cause serious adverse events, including infections, increased blood glucose (sugar) levels, changes in blood pressure, damage to bones, psychiatric problems, and adrenal dysfunction.These products are promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions and are sold on various websites and in some retail stores.įDA laboratory analyses revealed certain Artri and Ortiga products contain the undeclared drug ingredients: ![]() FDA urges consumers taking these products to immediately talk to their health care professional (e.g., doctor) to safely discontinue use of the product because suddenly stopping these drugs may be dangerous. 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. Walmart and Latin Foods Market already issued voluntary recalls. In support of public safety, and because some of these products may still be available on the market, FDA issued warning letters to Amazon, Walmart, and Latin Foods Market for distributing various “Artri” and/or “Ortiga” unapproved and misbranded drug products. In addition, the agency issued a warning letter and an import alert for certain products. FDA continues to warn consumers to avoid use of these products that contain potentially harmful hidden ingredients. Some of these problems can be life threatening or fatal. Reported harmful effects include sudden weight gain, serious gastrointestinal damage including bleeding and ulceration, increased blood glucose (sugar) levels, adrenal dysfunction, liver toxicity, and other serious conditions. Even if a product is not included in this list, consumers should exercise caution before using these types of arthritis and pain management products.Since April 20, 2022, FDA learned that more than 30 additional consumers have experienced a serious health effect after using unapproved over-the-counter products with “Artri” or “Ortiga” in the product name. The list below includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. FDA is committed to protecting consumers from the risks of buying medicines online and helping them be more aware of how to buy online safely. Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.įDA encourages consumers and health care professionals to report any adverse events to the agency’s MedWatch Adverse Event Reporting program so the agency can take action to protect the public from any unsafe products. FDA cannot test all products on the market that contain potentially harmful hidden ingredients. It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers. ![]() ![]() Consumers should use caution when considering purchasing these types of products. These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking. The public notifications listed below include those products FDA testing found to contain active drug ingredients not listed on the product labels, including some with ingredients found in prescription drugs. FDA is notifying consumers of certain products promoted for arthritis and pain management that have been found to contain hidden ingredients and may pose a significant health risk.
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