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FDA: Don’t Ingest Ortiga; Contains Unlabeled Prescription Drug Ingredient

Filed August 23rd, 2013 edlieber1

The U.S. Food and Drug Administration (FDA) is instructing consumers not to buy or use Ortiga, an unapproved product promoted for a variety of health conditions and sold on multiple websites and in some retail stores.

The FDA noted that Ortiga is manufactured in Mexico and labeled primarily in Spanish. The recommendation was made after FDA laboratory analysis confirmed that Ortiga contains the prescription drug ingredient diclofenac. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). Previous studies have found a link between NSAIDs and an 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. 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, the FDA said in its release.

The FDA recommends that consumers 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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