Published by What's the Problem?
This recall was initiated after an FDA analysis found the product to contain undeclared sibutramine and fluoxetine. Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the U.S. market due to safety issues including stroke, heart failure, and other serious health risks.
Fluoxetine is an FDA-approved drug used to treat depressive disorders, obsessive-compulsive disorder, bulimia, and panic disorders. It carries a boxed warning for suicidal thoughts and behaviors and needs to be monitored closely by a prescriber.
"Products containing undeclared sibutramine pose a threat to consumers because 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," FDA said.
"Products containing undeclared fluoxetine could cause suicidal thinking and behavior, an accumulation of high levels of serotonin in the body or neuroleptic malignant syndrome (NMS)-like reactions which is a life-threatening neurological disorder; elevated mood state that can cause higher than normal energy levels, restlessness, decreased need for sleep; abnormal bleeding, and low sodium levels."
Imperia Elita Vitaccino Coffee is marketed as a dietary supplement for weight loss and is packaged in a black rectangular box and contains 15 sachets. The affected products were distributed nationwide via Internet sales.
If you purchased any coffee that is affected by this recall, you should either throw it away or return it to the point of purchase for a refund.
This recall began on May 11, 2021.
Anyone concerned about a potential adverse reaction to dietary supplements should contact their healthcare provider immediately.
Adulteration of Weight Loss Supplements by the Illegal Addition of Synthetic Pharmaceuticals: Study
A study published in the journal Molecules [1.] in November 2021 looked at illegally added pharmaceuticals, specifically fluoxetine, phenolphthalein, and sibutramine, in herbal weight loss supplements.
For the study, researchers collected and analyzed 137 weight loss supplements with reversed-phase high-performance liquid chromatography to determine the presence of the pharmaceutical chemicals.
Among the weight loss supplements, 15.3% (95% CI: 9.2–21.4) contained undeclared sibutramine, 13.9% (95% CI: 8.01–19.7) contained undeclared phenolphthalein, and 5.1% (95% CI: 1.4–8.8) contained undeclared fluoxetine. Amongst all weight loss supplements, 17.5% (95% CI: 11.07–24) contained significant concentrations of either sibutramine, phenolphthalein, or fluoxetine.
The study's authors concluded that while most weight loss herbal supplements have relatively low percentages of undeclared pharmaceuticals, many people take several different supplements daily and may encounter quite high levels of combined exposure to toxic compounds.
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