Safety Alerts & Recalls

What does this mean?

If you take Ortiga, you should stop using this product immediately and dispose of it. Please consult a healthcare professional as soon as possible if you have experienced any negative side effects, such as unusually dark stools or urine, stomach pain, increased bruising, or other signs of bleeding.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: www.fda.gov/medwatch

Consumers Warned Not to Purchased Ortiga, an Unapproved Product

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.

The 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.

For more information, please visit: more information here

Source: FDA
Publication Date: 2013-08-30
Last Updated: 2013-09-16

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