The US Centers for Disease Control and Prevention (CDC) has identified a “cluster of severe illness” associated with products containing the unapproved drug tianeptine, colloquially known as “gas station heroin,” which may also include synthetic cannabis.
Neptune Resources, a manufacturer of certain tianeptine products, has initiated a nationwide recall, as indicated in a recent announcement.
The company, asserting that its products have not been linked to any reports of adverse events, is issuing letters to all distributors and customers.
Moreover, arrangements are being made for the retrieval of the recalled products, encompassing all batches of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets.
The US Food and Drug Administration notes that tianeptine is a prescribed antidepressant utilized in Europe, Asia, and Latin America for the treatment of major depressive disorder.
FDA Issues Warning on Illicit Tianeptine Products in the US
In the United States, tianeptine products are frequently illicitly distributed through online platforms and gas stations, masquerading as dietary supplements with purported benefits for enhancing cognitive function and addressing conditions such as anxiety, depression, pain, and opioid use disorder, according to the FDA.
These tianeptine-containing products are available under various brand names, including Pegasus and Zaza, as indicated by the CDC.
The FDA has issued a stern warning, advising consumers against the acquisition or usage of tianeptine products due to substantial risks, including the potential for seizures, loss of consciousness, and fatal outcomes.
Two Deaths Linked to Tianeptine Products
Recent data indicates that at least two fatalities associated with tianeptine products marketed as dietary supplements have been reported to the FDA.
Neptune Resources LLC, the manufacturer of these products, asserts that there have been no reports of adverse events through its distribution channels.
A CDC report published on Thursday underscores Neptune’s Fix as the predominantly utilized product in cases of tianeptine exposures reported to the New Jersey Poison Control Center during the latter half of 2023.
Between June and November, the center received 20 exposure calls from healthcare facilities concerning tianeptine use in 17 individuals—a notable surge from the center’s typical annual average of two or fewer cases.
Of these 17 cases, 13 necessitated admission to intensive care units, and seven required intubation, according to the report.
However, no deaths were reported in these instances.
