FDA Warns OxyElite Pro Super Thermogenic Has ProzacMarch 2, 2015 — The FDA is warning consumers not to buy or use OxyElite Pro Super Thermogenic because it contains fluoxetine, the active ingredient in the antidepressant Prozac.

OxyElite Pro Super Thermogenic is a weight-loss supplement made by USPLabs, LLC, based in Dallas, Texas. The company is already facing a number of lawsuits, including class actions.

FDA laboratory analysis of an international mail-order shipment detected fluoxetine, which is a prescription drug in a class of antidepressants known as SSRIs (selective serotonin reuptake inhibitors). The FDA’s criminal division has been investigating USPlabs for mail fraud since early this year.

The FDA warns:

“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.”

USPLabs claims the supplement that was tested by the FDA was a counterfeit. OxyElite Pro Super Thermogenic is advertised on the website www.oxyelite-pro.com, as a “USPLabs fat burner” but “not run by or affiliated with USPLabs in any way.”

Whoever made the product, this is not the first time OxyElite Pro has been in the FDA’s crosshairs. It was originally pulled off the market because it contained DMAA (1,3-dimethylamylamine), a powerful synthetic stimulant that was linked to dozens of adverse events, including cardiac arrest and death.

In 2013, after USPlabs re-formulated OxyElite Pro without DMAA — but then replaced it with other unapproved ingredients, such as aegeline.

Soon afterward, over 50 cases of liver damage and acute hepatitis (liver inflammation) were linked to OxyElite Pro and a recall was issued in November. Several people developed liver failure and one mother from Hawaii died.

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