Days after the Food and Drug Administration published a warning about the use of tianeptine, the makers of Neptune's Fix have issued a recall of the product.
Products made with tianeptine have come under intense scrutiny in recent months, with lawmakers dubbing the items as "gas station heroin." Earlier this month, a bipartisan group of members of Congress signed a letter urging the FDA to regulate tianeptine more tightly.
The lawmakers claim that tianeptine has "opioid-like qualities" and is extremely addictive, citing University of Alabama-Birmingham research.
Neptune Resources, makers of Neptune's Fix, said consumers are encouraged to either immediately destroy the products or return them to the place of purchase.
"There is a reasonable probability of life-threatening events including suicidal ideation or behavior for children, adolescents, and young adults 25 and younger. In addition, individuals could unintentionally overdose and experience serious and potentially life-threatening risks including confusion, seizures, drowsiness, dry mouth, and shortness of breath, which may be exacerbated by alcohol use," the FDA said. "Further, the risks of adverse effects associated with use of tianeptine along with antidepressants, known as monoamine oxidase inhibitors (MAOls), are potentially serious and life-threatening."
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The U.S. Department of Justice said tianeptine has been used in counterfeit pills mimicking hydrocodone and oxycodone or bags of heroin. The DOJ said the drug has caused withdrawal symptoms severe enough to cause hospitalization.
Other products made with tianeptine branded as Tianna and Zaza were not included in the recall.
