The FDA is advising against the purchase and use of Ortiga, an unapproved product promoted for a range of health conditions. Ortiga is manufactured in Mexico and is sold on multiple websites and in some retail stores–primarily labeled in Spanish.

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FDA analysis confirmed that Ortiga contains diclofenac, a prescription non-steroidal anti-inflammatory (NSAID). NSAIDs may cause increased risk of cardiovascular events (eg, heart attack, stroke), and gastrointestinal damage (eg, bleeding, ulceration, fatal stomach and intestinal perforation). Diclofenac may also increase the risk of adverse events in consumers taking multiple NSAID-containing products.

It is recommended that consumers immediately stop using this product and dispose of it. Consumers are to consult their healthcare provider if they have experienced any adverse events, such as unusually dark stools or urine, stomach pain, increased bruising, or other signs of bleeding.

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