If You Take This Supplement, Stop Immediately, FDA Warns
The supplement may contain prescription medication that can cause serious health problems for users.
If you've been trying to shed a few pounds gained amid the pandemic, you're far from alone. However, if you're taking supplements to boost your weight loss efforts, you could be putting yourself in harm's way.
While adding any supplement to your regular routine—be it a vitamin or natural sleep remedy—is a plan best run by your doctor first, one supplement in particular could present a serious risk to your health and should be thrown away immediately, according to the U.S. Food & Drug Administration (FDA). Read on to discover if you should be tossing this supplement now.
Dash Xclusive has recalled a weight loss and anxiety supplement.
On May 11, the FDA announced that California-based Dash Xclusive had voluntarily recalled its Imperia Elita Vitaccino Coffee, a supplement that supposedly aids in weight loss and reduces anxiety.
The recalled product, which was sold via eBay and online, comes in a rectangular black box that contains 15 sachets of the coffee supplement. The company is using eBay's messaging system to alert individuals who purchased the supplement and is coordinating the return of the affected products.
For the latest recall news delivered straight to your inbox, sign up for our daily newsletter.
The supplement is contaminated with two prescription medications.
Imperia Elita Vitaccino Coffee is being pulled from the market after it was discovered during the course of an FDA analysis that the product is contaminated with sibutramine, a weight loss aid formerly sold under the brand name Meridia, and fluoxetine, a selective serotonin reuptake inhibitor (SSRI), which you probably know as the brand name Prozac. Neither medication is disclosed on the supplement's label.
According to the recall notice, fluoxetine has been linked to abnormal bleeding, restlessness, a reduction in the need for sleep, life-threatening neuroleptic malignant syndrome, significant serotonin increases, low sodium levels, and suicidal thoughts or behavior. Sibutramine, on the other hand, has been linked to significant increases in blood pressure that present serious cardiovascular risks, particularly among those with preexisting heart-related health issues. If you have the recalled supplements at home, the FDA recommends that you stop using them immediately and return them to Dash Xclusive at 610 S. Verdugo Road, Apt 31, Glendale, California 91205. If you have questions related to the recall, you can contact email@example.com. If you believe you've experienced side effects related to taking the recalled supplement, contact a medical professional.
One of the undeclared medications in the supplements had already been pulled from the market due to safety concerns.
The sibutramine found in Imperia Elita Vitaccino Coffee has been a concern for health authorities for some time now. In Oct. 2010, the FDA issued a safety announcement for the medication, recommending that it no longer be prescribed in the U.S.
In the statement, the FDA noted that the medication "may pose unnecessary cardiovascular risks to patients." The agency cited data from the Sibutramine Cardiovascular Outcomes (SCOUT) trial, which showed that taking the medication increased the risk of serious cardiovascular events—including non-fatal heart attacks, non-fatal strokes, cardiac arrest followed by resuscitation, and cardiovascular death—by 16 percent. The drug has since been pulled from the market in the U.S. and the European Union, Australia, Canada, China, India, and Mexico, among others.
The FDA issued a warning for another weight loss supplement sold on eBay in late 2020.
This isn't the first time a supplement sold on eBay has been cited as cause for concern by the FDA recently. In Dec. 2020, the FDA released a statement cautioning against the use of more than 50 weight loss and male performance supplements sold on eBay and Amazon that were "found to contain hidden ingredients and may pose a significant health risk."
The FDA tested 26 supplements sold Amazon and an additional 25 from eBay; among the Amazon batch, 100 percent of the supplements were contaminated with "undeclared active pharmaceutical ingredients," and the same was true of 80 percent of those from eBay.