Oxy ELITE Pro Super Thermogenic, a weight-loss supplement manufactured by USPlabs, contains the prescription drug Prozac, according to a letter released today by the FDA.
Oxy ELITE Pro Super Thermogenic, a dietary supplement marketed for weight loss, contains the prescription drug fluoxetine, better known as Prozac.
In a public notification letter released today, the Food and Drug Administration (FDA) warned consumers "not to purchase or use" the product.
The FDA found Prozac, or fluoxetine, in Oxy ELITE Pro Super Thermogenic during an "examination of international mail shipments," the letter said.
Fluoxetine is a selective serotonin reuptake inhibitor, or SSRI, a class of prescription drug that is commonly used to treat depression, obsessive-compulsive disorder, and panic disorder.
"Uses of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures," the FDA letter said.
This is not the first time that the supplement's manufacturer, Texas-based USPlabs, has been sanctioned by the FDA. It's not even the first time an Oxy product has.
In 2011, an earlier version of the product, called OxyElite Pro, was found to contain dimethylamylamine, or DMAA, a synthetic stimulant linked to bleeding strokes and sudden deaths. The FDA banned DMAA in 2012, but USPlabs kept selling the stimulant for more than a year.
After the company removed DMAA, it reformulated OxyElite Pro and added a new ingredient, called aegeline. In May 2013, this new version of the supplement spurred an outbreak of hepatitis and liver disease, and six months later the company recalled it. A subsequent investigation by the Centers for Disease Control and Prevention linked OxyElite Pro to 97 cases of hepatitis, resulting in 47 hospitalizations, three liver transplantations, and one death.
Even after that, "the FDA did nothing to stop them from reformulating OxyElite Pro yet again," Pieter Cohen, assistant professor of medicine at Harvard University, told BuzzFeed News.
And now the FDA announced that yet another version of the Oxy product contains Prozac, a prescription drug not listed on the label.
"The current system to eliminate dangerous supplements in the U.S. is fatally flawed," Cohen said. "Loosey-goosey laws combined with the FDA's lackadaisical approach to regulating the supplement industry places millions of consumers at risk."
OxyElite Pro can be sold without going through a formal FDA-approval process because it is considered a dietary supplement. "These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being 'all natural'," the FDA letter read.
But consumers should be warned that many supplements — at least 574 products identified so far — are tainted with synthetic pharmaceutical compounds.
"FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients," the letter said.
USPlabs has not responded to requests for comment.
from BuzzFeed - USNews http://ift.tt/1EAsZiX
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