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. Consumers should exercise caution before purchasing any product in the above categories.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. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Note: This notification is to inform the public of products marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals.
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Download and complete the form, then submit it via fax at 1-80.Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or.
Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program: Methocarbamol can also impair mental and physical abilities to perform certain tasks, such as driving a motor vehicle or operating machinery. Methocarbamol is a muscle relaxant that can cause sedation, dizziness, and low blood pressure. 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. 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. 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.
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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.
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