- A weight-loss coffee product was found two contain two undeclared drugs
- One of them is an appetite suppressant that was pulled from the market
- The other is a treatment for several depressive disorders
- The FDA has been warning about products with hidden and potentially dangerous ingredients that are sold online
A weight-loss coffee product is being recalled for containing two undeclared ingredients. One of them poses serious heart risks while the other may cause suicidal thoughts.
Dash Xclusive from Glendale, California, is voluntarily recalling its Imperia Elita Vitaccino Coffee for containing undeclared ingredients, the recall alert posted on the Food and Drug Administration’s (FDA) website said. Specifically, the FDA found that it contains undeclared sibutramine and fluoxetine, thus making the coffee product an “unapproved drug.”
What’s more, the drugs themselves may pose risks of their own especially since they are not declared in the ingredients. Sibutramine was once approved by the FDA as an appetite suppressant and classified as a Schedule IV controlled substance. It is typically orally administered as a treatment for obesity, Drugbank noted, but it was eventually pulled from the market in the U.S. and Canada in 2010 because of concerns that it may increase the risks of heart attack and strokes, particularly among those with a history of heart-related conditions.
On the other hand, fluoxetine is an FDA-approved drug for several depressive disorders including bulimia and obsessive-compulsive disorder, the FDA said. However, it also poses some serious risks, including having suicidal thoughts.
“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,” the FDA said.
“This drug product carries a box warning for suicidal thoughts and behaviors and it needs to be monitored closely by a prescriber,” it added.
The recall affects all lots of the products, which were sold nationwide via online platforms including eBay. The company is already notifying its consumers, who are being advised to stop using it.
FDA Warning About ‘Hidden’ Ingredients
In a press release last December, the agency noted that it has been warning consumers about such products with hidden and potentially dangerous ingredients in the past decade yet it continues to find them in online markets.
Although many of the drugs that can be found in such products are actually FDA-approved, they are prescription drugs that can only be used with the supervision of a licensed healthcare professional, the FDA explained.
“The FDA’s tainted products database can help consumers identify nearly 1,000 of these potentially dangerous products. However, the agency is unable to test and identify all products that have potentially harmful hidden ingredients,” the FDA said, urging consumers to be cautious about such products, especially if they “sound too good to be true.”