[8-22-2013] 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 www.ebay.com, and in some retail stores. The product is manufactured in Mexico and labeled primarily in Spanish.
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.
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.
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:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- 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
Note: The purpose of this notification is to inform the public of a growing trend of dietary supplements or conventional foods containing hidden drugs and chemicals. These products are typically promoted to unsuspecting customers for sexual enhancement, weight loss, and body building, or for other medical uses and are often represented as being “all natural.” FDA is unable to identify and test all such products that may have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
Please refer to the links below for more information: