Note: The purpose of this notification is to inform the public of a growing trend of dietary supplements or conventional foods containing hidden drugs and chemicals. Download form or call 1-80 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-80.Complete and submit the report Online:.Health care professionals and patients are encouraged to report adverse events or side effects related to Ortiga to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Consumers should consult a health care professional as soon as possible if they have experienced any negative side effects, such as unusually dark stools or urine, stomach pain, increased bruising, or other signs of bleeding. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.Ĭonsumers should stop using this product immediately and dispose of it. NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). The product is manufactured in Mexico and labeled primarily in Spanish.įDA laboratory analysis confirmed that Ortiga contains the prescription drug ingredient, diclofenac. Methocarbamol may cause dizziness and low blood pressure, it said.The Food and Drug Administration (FDA) is advising consumers not to purchase or use Ortiga, an unapproved product promoted for a variety of health conditions and sold on multiple websites, including and in some retail stores. The Artri King products are made by supplements maker NaturaMex.ĭexamethasone could cause serious adverse events including infections and elevated sugar levels while diclofenac sodium could lead to heart attack and stroke or gastrointestinal damage, the FDA warned on Wednesday. The agency said it has received reports of adverse events including of liver toxicity and death, associated with the use of Artri King products since the warning. The FDA in January had first issued a warning about Artri Ajo King, asking consumers not to purchase the product sold for joint pain and arthritis on various websites, including. The FDA said it found the hidden drug ingredients in Artri Ajo King, Artri King, Ortiga Mas Ajo Rey and Ortiga Mas Ajo Rey Extra Forte products. The products are marketed to treat arthritis, muscle pain and other conditions and are sold online and in some retail stores, the agency said. The agency said its laboratory analyses revealed some of the products contain dexamethasone, a corticosteroid, anti-inflammatory drug diclofenac sodium and methocarbamol, which is a muscle relaxant. Food and Drug Administration (FDA) on Wednesday asked people to not buy or use certain dietary supplement products sold with variations of the names 'Artri' or 'Ortiga' as they may contain some potentially harmful ingredients not mentioned on their labels.
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