Removing Tianeptine Products From the U.S. Market: Stronger FDA Actions Needed

In the July 2021 issue of Worst Pills, Best Pills News, Public Citizen’s Health Research Group cautioned consumers about the risks of tianeptine — an addictive synthetic chemical substance with opioid-like effects that is associated with serious health risks and even death. Tianeptine also can be abused and can cause physical dependence (needing to use increasingly higher doses) and withdrawal adverse reactions.[1],[2]

Although regulatory agencies in some countries classify tianeptine as a drug, the Food and Drug Administration (FDA) classifies it as an unsafe food additive and has not approved it for any medical use.[3] Still, some companies have been illegally selling tianeptine-containing products in U.S. gas stations, convenience stores, and smoke and vape shops, as well as online.[4] These products are available in oral formulations (including tablets, elixirs and powders) and are sold under various names (such as Neptune’s Fix, Pegasus, Tianaa and ZaZa).

Companies promote tianeptine products to improve brain function and to treat anxiety, depression, opioid use disorder, pain and other conditions. There is no evidence, however, to substantiate these claims.[5] Instead, in 2023, tianeptine was implicated in at least 391 poisoning cases throughout the United States.[6] Notably, from June to November 2023, 20 cases of serious adverse effects associated with exposure to tianeptine were reported in New Jersey, a sharp increase in such cases in the state.[7] Florida, Kentucky, Michigan, Ohio and other states have banned tianeptine or designated it as a controlled substance.

For several years, the FDA has alerted consumers about reports of serious adverse effects associated with the use of tianeptine and cautioned that the substance has potentially deadly interactions with certain medications. Only in recent months has the agency accelerated efforts to remove tianeptine products from the U.S. market.

Slow, inadequate FDA actions

In 2018 the FDA urged consumers to avoid all tianeptine-containing products and sent warning letters to two online companies that were illegally marketing tianeptine products as dietary supplements.[8]

In 2022 the agency issued a consumer update that reiterated its warnings about the risks of tianeptine and noted that the agency had issued warning letters and import alerts to stop tianeptine shipments to the United States.[9]

Since November 2023 the FDA has urged consumers not to purchase the tianeptine-containing product Neptune’s Fix, noting that ingestion of the product has led to multiple reports of serious adverse effects (including loss of consciousness, seizures and death).[10] The agency has investigated adverse-event reports involving the product in collaboration with local and state health departments.

In January 2024 the FDA sent a letter to convenience stores, gas stations and other businesses asking them to stop selling Neptune’s Fix and any other tianeptine-containing products.[11] As of June 2024, at least two distributors of Neptune’s Fix (Neptune Resources, LLC and Super Chill Products) have announced that they are voluntarily recalling this product from the U.S. market.[12],[13] Notably, in its recall announcement Neptune Resources, LLC acknowledged that tianeptine may cause life-threatening adverse events, including suicidal ideation or behavior in children, adolescents and adults younger than 26. The company added that users of this product can unintentionally overdose and experience serious risks (including confusion, drowsiness, dry mouth, seizures and shortness of breath), which may be worsened by alcohol use. Additionally, Neptune Resources, LLC cautioned about the risks of potentially serious and life-threatening adverse events when tianeptine is taken concomitantly with a class of antidepressants known as monoamine oxidase inhibitors. Examples of these drugs include isocarboxazid (MARPLAN), rasagiline (AZILECT and generics) and selegiline.

Despite these actions, tianeptine products continue to be available online (allegedly to be used “primarily for research purposes”).[14] The FDA should obtain data on the extent to which these products are still available in stores and online and be more forceful in protecting consumers. As called for in a 2020 letter from the Center for Science in the Public Interest, the FDA should promptly work with the Department of Justice and state officials (including health officers and attorneys general) to identify all companies that are promoting, distributing or selling tianeptine (online or in stores) and take suitable actions to eliminate tianeptine from the U.S. market.[15]

What You Can Do

Avoid all products that contain tianeptine. Contact your clinician if you have experienced any health problems that may be related to ingestion of tianeptine.

Seek medical attention if you are struggling with anxiety, depression, opioid use disorder or another related condition.

Report all serious adverse events related to tianeptine or any drugs or supplements to the FDA’s MedWatch adverse-event reporting program by visiting www.fda.gov/MedWatch or by calling 800-FDA-1088.
 

References

[1] FDA needs to quickly ban the illegal opioid-like substance tianeptine. Worst Pills, Best Pills News. July 2021. https://www.worstpills.org/newsletters/view/1412. Accessed June 2, 2024.

[2] Kisa C, Bulbul DO, Aydemir C, Goka E. Is it possible to be dependent to tianeptine, an antidepressant? A case report. Prog Neuropsychopharmacol Biol Psychiatry. 2007;31(3):776-778.

[3] Food and Drug Administration. Tianeptine in dietary supplements. February 22, 2024. https://www.fda.gov/food/information-select-dietary-supplement-ingredients-and-other-substances/tianeptine-dietary-supplements. Accessed June 2, 2024

[4] Hoffman BJ. ‘Gas-Station Heroin’ sold as dietary supplement alarms health officials. New York Times. January 10, 2024. https://www.nytimes.com/2024/01/10/health/gas-station-heroin-tianeptine-addiction.html. Accessed June 2, 2024.

[5] Food and Drug Administration. Tianeptine. February 15, 2024. https://www.fda.gov/consumers/health-fraud-scams/tianeptine. Accessed June 2, 2024.

[6] Hoffman BJ. ‘Gas-Station Heroin’ sold as dietary supplement alarms health officials. New York Times. January 10, 2024. https://www.nytimes.com/2024/01/10/health/gas-station-heroin-tianeptine-addiction.html. Accessed June 2, 2024.

[7] Counts CJ, Spadaro A V, Cerbini TA, et al. Notes from the field: Cluster of severe illness from Neptune’s Fix tianeptine linked to synthetic cannabinoids - New Jersey, June-November 2023. MMWR Morb Mortal Wkly Rep. 2024;73(4):89-90.

[8] Food and Drug Administration. FDA takes action on products marketed as dietary supplements containing tianeptine and warns consumers. November 20, 2018. https://www.fda.gov/food/cfsan-constituent-updates/fda-takes-action-products-marketed-dietary-supplements-containing-tianeptine-and-warns-consumers. Accessed June 2, 2024.

[9] Food and Drug Administration. Tianeptine products linked to serious harm, overdoses, death. February 10, 2022. https://www.fda.gov/consumers/consumer-updates/tianeptine-products-linked-serious-harm-overdoses-death. Accessed June 2, 2024.

[10] Food and Drug Administration. FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks. February 15, 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. Accessed June 2, 2024.

[11] Food and Drug Administration. Letter urging all retailers to STOP selling Neptune’s Fix and any tianeptine-containing products. January 11, 2024. https://www.fda.gov/media/175628/download. Accessed June 2, 2024.

[12] Food and Drug Administration. FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks. February 16, 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. Accessed June 2, 2024.

[13] Food and Drug Administration. Neptune Resources, LLC issues voluntary nationwide recall of Neptune’s Fix. January 28, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/neptune-resources-llc-issues-voluntary-nationwide-recall-neptunes-fix. Accessed June 2, 2024.

[14] Tianeptine Direct. Terms and conditions of purchasing tianeptine. 2024. https://tianeptinedirect.com/legal-disclaimer/. Accessed June 2, 2024.

[15] Center for Science in the Public Interest. Letter to the Food and Drug Administration regarding tianeptine. August 25, 2020. https://www.cspinet.org/sites/default/files/attachment/Tianeptine_Letter_FDA_0.pdf. Accessed June 2, 2024.