Ortiga: Public Notification - Contains Hidden Drug Ingredient
Audience: Consumer, Patient, Health Professional
ISSUE: 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 Ebay, and in some retail stores. The product is manufactured in Mexico and labeled primarily in Spanish.
BACKGROUND: FDA laboratory analysis confirmed that Ortiga contains the prescription drug ingredient, diclofenac. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). 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. 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.
RECOMMENDATION: 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.
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/22/2013 - Public Notification - FDA]
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