Tianeptine Products Linked to Serious Harm, Overdoses, Death
The U.S. Food and Drug Administration (FDA) issued a public safety alert on November 21, 2023, after receiving multiple reports of serious medical injuries related to “Neptune’s Fix.” Neptune’s Fix is labeled to contain the dangerous and addictive ingredient tianeptine. Tianeptine is not approved for any medical use in the United States and is often unlawfully labeled or sold as a dietary supplement. The FDA continues to receive reports of consumers who have suffered seizures, loss of consciousness or other adverse health events after ingesting this product. The FDA is reaching out because most consumers report purchasing this product at local gas stations or convenience stores across the country.
FDA is urging all retailers to STOP selling Neptune’s Fix and any tianeptine-containing products. The FDA is asking that healthcare providers please share the message above and information below to keep consumers safe:
- FDA warns consumers not to purchase or use any tianeptine product due to serious risks: SEE HERE
Furthermore, the FDA is actively investigating new reports in conjunction with local and state health departments. The FDA is also aware that tianeptine-containing products are sold illegally online and in other retail locations. At least twelve states have banned the sale of tianeptine. According to the U.S. Centers for Disease Control and Prevention (CDC), the clinical effects of tianeptine abuse and withdrawal can mimic opioid toxicity/withdrawal.
Tianeptine Isn’t FDA Approved for Any Medical Use
Tianeptine is an unapproved drug in the United States. Although other countries have approved tianeptine to treat depression and anxiety, some have restricted how tianeptine is prescribed or dispensed, or revised the drug label to warn of possible addiction. In the U.S., reports of bad reactions and unwanted effects involving tianeptine are increasing. Poison control center cases involving tianeptine exposure have increased nationwide, from 11 total cases between 2000 and 2013 to 151 cases in 2020 alone.
Tianeptine Presents Safety Risks and Can Be Abused
Cases described in medical journals, in calls to U.S. poison control centers, and in reports to the FDA suggest that tianeptine has a potential for abuse. People with a history of opioid use disorder or dependence may be at particular risk of abusing tianeptine.
Some people have turned to tianeptine as an opioid alternative, or to self-treat anxiety or depression. Medical journals and reports to the FDA suggest that adverse events may occur when tianeptine is taken at doses higher than the doses prescribed in the countries where the drug has been approved. Some people may have difficulty stopping their use of tianeptine and may experience withdrawal symptoms. The clinical effects of tianeptine abuse and withdrawal can mimic opioid toxicity and withdrawal, according to the CDC.
The FDA has identified cases in which people experienced other serious harmful effects from abusing or misusing tianeptine by itself or with other drugs, including antidepressants and anti-anxiety medicines. These effects included agitation, drowsiness, confusion, sweating, rapid heartbeat, high blood pressure, nausea, vomiting, slowed or stopped breathing, coma, and death.
FDA Actions to Protect Consumers
The FDA has taken steps to protect people from unapproved tianeptine products, including warning consumers that tianeptine is an unsafe food additive and not a dietary ingredient. The FDA has also issued warning letters to companies illegally marketing tianeptine products as dietary supplements and unapproved drugs. Additionally, the FDA has issued import alerts to help stop tianeptine shipments at our borders and will continue to take regulatory action to discourage the importation and marketing of unapproved tianeptine products. In the meantime, anyone can report an adverse event involving tianeptine by using FDA’s MedWatch Safety Information and Adverse Event Reporting Program
The complete Drug Safety Communication can be viewed on the FDA website .
