Citing Severe Health Risks, FDA Issues Warning Against Using Tianeptine Products

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Atypical antidepressant linked to severe adverse effects and death as a result of misuse.

A microscopic view of the molecular structure of tianeptine, a tricyclic antidepressant. Generative AI. Image Credit: Adobe Stock Images/Genevieve

Image Credit: Adobe Stock Images/Genevieve

This week, the FDA released a statement warning consumers to stay away from Neptune Resources’ Fix Elixir, Fix Extra Strength Elixir, and Fix Tablets. Citing potential adverse events (AEs) such as seizures, loss of consciousness, and death, the agency stated that they have continued to receive several reports of these AEs. After releasing an initial warning statement in November, the FDA sent a letter on January 11, 2024, to multiple retailers, stressing the need to pull Neptune’s Fix and any other tianeptine-containing products from their inventory.1

“Neptune's Fix labels state the product contains tianeptine, but the product may contain other harmful ingredients not listed on the label,” the agency said in the statement “These products, like other tianeptine products, can be purchased online and at gas stations, vape or smoke shops, or other locations. FDA is testing these products and will provide more information as it becomes available. FDA also continues to warn consumers about risks of using tianeptine.”

According to a 2018 study by the CDC, misuse of tianeptine calls to US poison control centers increased from 2014-2017. Their report indicated that the most common health effects included neurologic, cardiovascular, and gastrointestinal issues, occasionally mirroring the effects of opioid withdrawal.2

Using data collected from the National Poison Data System (NPDS) from 2000-2007, the CDC discovered during that time, a total of 218 calls related to tianeptine exposure were placed, with 52.3% of exposures being tianeptine-only. Of those exposures, 54% experienced a moderate reaction and no deaths were reported to the NPDS. Those who experienced withdrawal symptoms reported agitation, nausea, vomiting, tachycardia, hypertension, diarrhea, tremors, and diaphoresis.2

Treatments for tianeptine-only exposures included:

  • Fluids: 35.1%
  • Benzodiazepines: 27.2%
  • Oxygen: 10.5%.2

Therapies for withdrawal symptoms included:

  1. Benzodiazepines: 57.1%
  2. Fluids: 38.1%
  3. Antiemetics: 19.1%.2

Earlier this month, a bipartisan group of US Congress members drafted a letter in which they requested more action from the FDA regarding the use of tianeptine, which has been labeled “gas station heroin.” Pointing out that multiple states have already begun the process of controlling the sale of tianeptine, the Congress members pressed the agency on actions that have been taken outside of warnings issued in 2018, 2022, and 2023.3

“The FDA first issued a warning on tianeptine use in 2018, noting that users may “inadvertently find themselves addicted to tianeptine and should avoid all products containing this ingredient,” the letter stated. “Your agency issued an additional warning in 2022, warning that reports indicate that ‘tianeptine has a potential for abuse.’ And in November 2023, FDA issued a warning for consumers not to purchase or use any products sold under the brand Neptune’s Fix that contain tianeptine after reports of severe adverse events by users including seizures and hospitalizations. While we appreciate these warnings, we believe that more action on tianeptine use is needed to ensure the health and well-being of the American people.”

References

1. FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks. FDA. January 23, 2024. Accessed January 26, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-neptunes-fix-or-any-tianeptine-product-due-serious-risks

2. Characteristics of Tianeptine Exposures Reported to the National Poison Data System — United States, 2000–2017. CDC. August 3, 2018. Accessed January 26, 2024. https://www.cdc.gov/mmwr/volumes/67/wr/mm6730a2.htm

3. Reps. Jeff Jackson Requests FDA Action on “Gas Station Heroin” Use. House.gov. January 18, 2024. Accessed January 26, 2024. https://jeffjackson.house.gov/media/press-releases/reps-jeff-jackson-requests-fda-action-gas-station-heroin-use

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