![]() ![]() ![]() 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. Even if a product is not included in this list, consumers should exercise caution before using these types of arthritis and pain management products.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 list below includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. FDA is committed to protecting consumers from the risks of buying medicines online and helping them be more aware of how to buy online safely. Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.įDA encourages consumers and health care professionals to report any adverse events to the agency’s MedWatch Adverse Event Reporting program so the agency can take action to protect the public from any unsafe products. FDA cannot test all products on the market that contain potentially harmful hidden ingredients. It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers. Consumers should use caution when considering purchasing these types of products. These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking. The public notifications listed below include those products FDA testing found to contain active drug ingredients not listed on the product labels, including some with ingredients found in prescription drugs. FDA is notifying consumers of certain products promoted for arthritis and pain management that have been found to contain hidden ingredients and may pose a significant health risk. ![]()
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