Perfect Body Solutions and Burn 7: Public Notification - Undeclared Ingredients

[Posted 10/10/13]

AUDIENCE: Consumer, Health Professional

ISSUE: FDA is advising consumers not to purchase or use Perfect Body Solutions or Burn 7. FDA laboratory analyses confirmed that Perfect Body Solutions and Burn 7 contain sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. These products pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and can present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.  These products can also interact in life-threatening ways with other medications a consumer may be taking.

BACKGROUND: Perfect Body Solutions or Burn 7 are promoted for weight loss and sold on various websites and in some retail stores.

RECOMMENDATION: Consumers should stop using these products immediately and throw them 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

[10/10/2013 - Public Notification - FDA]
[10/10/2013 - Tainted Weight Loss Products- FDA]