![]() According to the FDA, "the undeclared diclofenac ingredient in “Artri Ajo King,” “Ortiga Mas Ajo Rey,” and “Artri King Reforzado con Ortiga y Omega 3” may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products."įor Amazon, by the way, this was not the first Warning Letter. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) which may cause increased risk of cardiovascular events. The FDA sees this as a potential health risk for consumers. This API was not listed on the product labels. It came out that they contained the active pharmaceutical ingredient (API) diclofenac. All products were introduced or delivered for introduction into interstate commerce by Amazon via the Fulfillment by Amazon service. The FDA then conducted laboratory analysis of these products. the agency writes that it purchased three products, “Artri Ajo King”, “Artri King Reforzado con Ortiga y Omega 3”, and “Ortiga Mas Ajo Rey”, via the website. Food and Drug Administration (FDA) has published two Warning Letters, both dated 28 October 2022. GMP Courses & Conferences on Site (in hotels).Download and complete the form, then submit it via fax at 1-80.Complete and submit the report online at or.Health care professionals and consumers should report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: The agency may take additional enforcement steps that may include warning letters, seizure, injunction, or criminal charges. Therefore, consumers should expect the manufacturing processes for Artri and Ortiga products are unreliable in providing consistent amounts of active ingredients or preventing the introduction of unknown chemicals or other impurities.įDA is investigating the distribution of these products in the United States and has advised certain companies not to sell or distribute these products. Products marketed as dietary supplements that are found to have hidden drug ingredients generally fail to comply with most current good manufacturing practices designed to ensure product quality and safety. 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.įDA has identified the following Artri and Ortiga products containing hidden drug ingredients:įDA analyses reflect only the undeclared ingredients discovered in one product from a specific lot, but ingredients may vary from product to product or from lot to lot. ![]() These risks depend on several factors that a health care professional must assess. ![]() Suddenly stopping corticosteroids after long-term use or high doses can result in a serious withdrawal syndrome that includes fatigue, nausea, low blood pressure, low blood glucose levels, fever, dizziness, muscle and joint pain, and shortness of breath. ![]() These drug ingredients, which are not listed on the product label, can also interact with other drugs a consumer is taking.įDA has received adverse event reports, including 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. Methocarbamol (a muscle relaxant) can cause sedation, dizziness, and low blood pressure. ![]()
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