FDA is advising consumers not to purchase or use Ortiga, an unapproved product promoted for a variety of health conditions that is sold on multiple websites and in some retail stores. FDA laboratory tests confirmed that Ortiga contains the prescription drug ingredient diclofenac. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID), a member of a class of drugs that are used to treat pain, fever and inflammation.
Risk: 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 holes in the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of health problems, particularly when consumers use multiple NSAID-containing products. The product is manufactured in Mexico and labeled primarily in Spanish.
Recommendations
- Consumers should stop using this product immediately and dispose of it.
- 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.
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