Fruta Planta: Public Notification - Undeclared Drug Ingredient

[UPDATED 02/02/2011] Godi International, Corp. Press Release added.

[UPDATED 01/03/2011] FDA Press Release link added.

[Posted 12/23/2010]

AUDIENCE: Consumer, Family Practice, Cardiology

ISSUE: FDA has received multiple reports of adverse events associated with the use of Fruta Planta, including several cardiac events and one death. FDA laboratory analysis confirmed that Fruta Planta contains sibutramine, a controlled substance that was withdrawn from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Fruta Planta may also interact in life threatening ways with other medications a consumer may be taking.

BACKGROUND: Fruta Planta is promoted and sold on various websites, such as www.frutaplanta.com, as a dietary supplement for weight loss.

RECOMMENDATION: Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products 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

[01/31/2011 - Press Release - Godi International]

[01/03/2011 - Press Release - FDA]

[12/22/2010 - Public Notification - FDA]

[December 2010 - Consumer Update: Tainted Products Marketed as Dietary Supplements - FDA]

[12/17/2010 - Medication Health Fraud - FDA]