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The U.S. Centers for Disease Control and Prevention (CDC) on Thursday warned of an “outbreak” linked to products containing the drug tianeptine.
The CDC announced that 20 cases related to tianeptine use in 17 unique patients were reported in New Jersey from June 2023 to November 2023. The CDC called this an “unusual spike” from the poison center's standard of no more than two exposure calls per year.
Of those 17 patients, about 14 reported receiving tianeptine from Neptune's Fix, a flavored elixir shot that was recalled earlier this week.
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On Sunday, Neptune Resources voluntarily recalled its Fix Elixir, Fix Extra Strength Elixir, and Fix Tablets after they were all found to contain the antidepressant tianeptine.
“These products are being recalled because they contain the ingredient tianeptine, which is not approved for medical use by the FDA,” the company said in a statement. “The presence of tianeptine makes the product unapproved drug Subject to recall as safety and effectiveness have not been established. ”
George Karavetzos, an attorney and former director of the FDA's Bureau of Criminal Investigation, said tianeptine has been called “gas station heroin.”
The dangers of this drug are that “companies are trying to convince U.S. consumers that tianeptine can improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions, which are dangerous and proven.” They are making medical claims that are not valid,” Karabetsos said.
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But he noted that “there are increasing reports of tianeptine being abused and used as an opioid substitute” and that tianeptine has been directly linked to overdose, coma and death.
The FDA published a notice online saying that “serious adverse events, including seizures, loss of consciousness, and death, continue to be reported after use of Neptune's Fix products.”
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“These products may also interact in life-threatening ways with other medications that consumers are taking,” the FDA said, adding that the agency is “working with local health care providers to report adverse events.” We are actively investigating,” he added. state health department. ”
According to the CDC, the drug is easily available as an elixir online or at gas stations and convenience stores.
In early January, the FDA sent a letter to groups such as convenience stores and gas stations asking retailers to stop selling Neptune's Fix and other tianeptine-containing products after receiving multiple reports of serious medical injuries. requested that it be cancelled.
