Weight Loss Products: Immediate Public Notification: Undeclared Drug Ingredients

Including:

Sport Burner (contains fluoxetine)
Toxin Discharged Tea (contains fluoxetine)
Sliming Diet (contains sibutramine)
 

[Posted 06/19/2014]

AUDIENCE: Consumer

ISSUE: FDA is advising consumers not to purchase or use these products, promoted and sold for weight loss on various websites and in some retail stores. FDA laboratory analysis confirmed that these products contain sibutramine or fluoxetine.

Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. 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. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.

Fluoxetine is an FDA approved drug in a class of drugs called selective serotonin reuptake inhibitors (SSRIs) used for treating depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphonic disorder (PMDD). Uses of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur.

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.

[06/19/2014 - Tainted Weight Loss Products - FDA]