CDC concerned with spike in illnesses linked to some tianeptine products

The Centers for Disease Control and Prevention (CDC) warned Thursday there has been a “cluster of illnesses” tied to products that contain the drug tianeptine.  

The CDC said 20 cases regarding tianeptine use in 17 unique patients were reported in New Jersey between June 2023 and November 2023. The agency called it an “uncharacteristic spike” from the poison center’s baseline of two or fewer exposure calls per year. 

Of those 17 patients, about 14 of them reported ingesting tianeptine from Neptune’s Fix, a flavored elixir shot that was recalled earlier this week. 

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On Sunday, Neptune Resources voluntary recalled all of its Fix Elixir, Fix Extra Strength Elixir and Fix Tablets after discovering they contained the antidepresent drug tianeptine. 

“The products are being recalled because they contain tianeptine, an ingredient that is not FDA-approved for any medical use,” the company said in a statement. “The presence of tianeptine renders the products unapproved drugs for which safety and efficacy have not been established and, therefore, are subject to recall.” 

George Karavetsos, an attorney and former director of the FDA’s Office of Criminal Investigations, said tianeptine has been dubbed “gas station heroin.” 

The danger of this drug is that “companies are making dangerous and unproven medical claims to U.S. consumers that tianeptine can improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions,” Karavetsos said. 

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However, he noted “there have been increased reports tianeptine is being abused and used as an opioid alternative” and that it has been directly linked to overdoses, coma and death. 

The FDA issued a notice online that it continues to “receive severe adverse event reports after use of Neptune‘s Fix products, including seizures, loss of consciousness and death.” 

“These products may also interact, in life-threatening ways, with other medications a consumer may be taking,” the FDA said, adding that the agency “is actively investigating adverse event reports in conjunction with local and state health departments.”

According to the CDC, the drug is readily purchased in elixir formulations either online or at gas stations and convenience stores.

In early January, the FDA sent a letter to organizations, including convenience stores and gas stations, urging retailers to stop selling Neptune’s Fix and any other tianeptine-containing products after receiving multiple reports of serious medical injuries.