March 2, 2015 — Lab tests by the FDA have detected fluoxetine, the active ingredient in the antidepressant Prozac, in OxyElite Pro Super Thermogenic.
The agency is warning consumers not to use the weight-loss supplement.
Fluoxetine is a prescription antidepressant in the selective serotonin reuptake inhibitor (SSRI) class. The FDA warned about a number of serious, life-threatening side effects:
“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.”
OxyElite Pro is made by USPLabs, LLC, based in Dallas, Texas. However, the company claims that the FDA tested a counterfeit product. Since January, the FDA’s criminal division has been investigating USPLabs for mail fraud. Fluoxetine was discovered in an international mail-order shipment.
OxyElite Pro Super Thermogenic is sold on the website www.oxyelite-pro.com, marketed as “The USPLabs fat burner” with the disclaimer “not run by or affiliated with USPLabs in any way.”
Counterfeit or not, OxyElite Pro has come under fire from the FDA several times. The first time was in 2012, when it was one of the most popular fat-burning supplements that contained DMAA (1,3-dimethylamylamine), a powerful stimulant that was linked to high blood pressure, cardiac arrest, and death.
USPLabs re-formulated OxyElite Pro with more unapproved ingredients, including aegeline. A few months later, health officials in Hawaii reported an outbreak of liver damage and acute non-viral hepatitis (liver inflammation). By the time OxyElite Pro was recalled in November, over 50 people were injured, several required liver transplants, and one woman died.
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