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.
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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:
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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. Consumers should exercise caution before purchasing any product in the above categories.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.
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.
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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