FDA Warns Consumers Against Purchasing Oxy Elite ProMar 4, 2015
The U.S. Food and Drug Administration (FDA) is cautioning consumers against buying Oxy Elite Pro and other weight loss supplements after a sample was found to have fluoxetine, the main active ingredient in the antidepressant Prozac. Youth Health reports that the tested sample was from another country. Oxy Elite Pro is a thermogenic, and attempts to boost the body's metabolism and burn fat by increasing the internal temperature.
The FDA has not approved fluoxetine for weight loss. The drug is a selective serotonin reuptake inhibitor (SSRI) used to treat disorders such as depression, bulimia, panic disorder and obsessive compulsive disorder. It is also sometimes used for premenstrual dysphonic disorder. Fluoxetine should not be taken lightly, as it is a powerful drug that can carry serious side effects. When used long-term, it can lead to seizures and abnormal bleeding. There are also several contraindications for fluoxetine, including patients taking ibuprofen or aspirin. Fluoxetine should also not be used in patients undergoing chemotherapy or who have a blood clot or heart condition. Serious side effects include irregular heartbeat (arrhythmia) and death.
The company that makes Oxy Elite Pro is USPLabs, who claims that the sample tested by the FDA is counterfeit. USPLabs says that product was seized in 2013, but is aware that some people continue to sell it online.
Last July, the FDA warned that tainted weight loss supplements were an emerging trend. The agency noted that consumers might unknowingly consume products tainted with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. Unlike drugs and medical devices, weight loss and dietary supplements are not heavily regulated by the FDA.