Wisconsin DHS Health Alert #59: Adverse Health Effects Linked to Neptune’s Fix and Other Products with Tianeptine

Bureau of Environmental and Occupational Health 

Key points

• Adverse health effects, including seizures, loss of consciousness, and death, have been reported after use of Neptune’s Fix and other products containing tianeptine.
• Tianeptine is not approved by the U.S. Food and Drug Administration (FDA) for any use and FDA has warned consumers not to purchase or use any tianeptine-containing products.
• The company responsible for Neptune’s Fix is voluntarily recalling its products; however, there are other tianeptine products available, especially online.

Background

• On January 11, 2024, the FDA sent a letter to gas stations, convenience stores, and other retailers urging them to stop selling Neptune’s Fix and other tianeptine-containing products.
• On January 23, 2024, the FDA issued a warning to consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious health risks.
• On January 28, 2024, the company responsible for Neptune’s Fix products issued a voluntary nationwide recall of all Neptune’s Fix products.
• Tianeptine is an atypical tricyclic drug that has not been approved by the FDA for medical use. Neptune’s Fix is sold as an elixir or in tablets and tianeptine is sold in tablet or powder form.
• Neptune’s Fix and other tianeptine-containing products have been sold at gas stations, convenience stores, and other retailers, including online.
• The adverse health effects of tianeptine products may be exacerbated by alcohol use and by interactions with other medications, especially certain antidepressants (monoamine oxidase inhibitors (MAOIs).
• With use of tianeptine, there is a risk of suicidal ideation or behavior in children, adolescents, and young adults 25 and under.

Information for health care providers

• Providers should be aware of the potential health risks of tianeptine products. A wide range of adverse health effects have been associated with tianeptine (alone or with other drugs) including agitation, drowsiness, sweating, high blood pressure, nausea, vomiting, slowed or stopped breathing, coma, and death.
• Those with opioid use disorder may be at risk of using or abusing tianeptine. Clinical effects of tianeptine abuse and withdrawal may mimic opioid toxicity and withdrawal.
• Providers can contact their local poison center for clinical guidance as needed (contact information below).
• Providers should report adverse effects to the FDA MedWatch reporting system (link below).

Resources

• Centers for Disease Control and Prevention. Characteristics of Tianeptine Exposures Reported to the National Poison Data System – United States, 2000-2017.
• Food and Drug Administration. Tianeptine Products Linked to Serious Harm, Overdoses, Death.
• FDA MedWatch reporting system (available to health care professionals, patients, and consumers)
• Wisconsin Poison Center. 1-800-222-1222 (available 24/7 for all individuals in Wisconsin)

Questions

Questions regarding this health alert may be directed to Dr. Sheryl Bedno via email to sheryl.bedno@dhs.wisconsin.gov. 

About the Wisconsin Health Alert Network 

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