In addition, the undeclared dexamethasone in Ortiga Mas Ajo Rey Extra Forte may cause serious side effects when combined with other medications.ĭiclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). Abrupt discontinuation can cause withdrawal symptoms. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression.ĭexamethasone is a corticosteroid commonly used to treat inflammatory conditions. The risks of withdrawal from corticosteroids should be assessed by a health care professional. Download and complete the form, then submit it via fax at 1-80.FDA laboratory analysis confirmed that Ortiga Mas Ajo Rey Extra Forte contains diclofenac, dexamethasone, and methocarbamol not listed on the product label.Ĭonsumers taking Ortiga Mas Ajo Rey Extra Forte should immediately consult with their health care professional to safely discontinue use of this product.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.Diclofenac sodium (an anti-inflammatory drug) 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) can cause serious adverse events, including infections, increased blood glucose (sugar) levels, changes in blood pressure, damage to bones, psychiatric problems, and adrenal dysfunction.
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