The U.S. Food and Drug Administration posted warning letter issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims. These actions follow reports to the FDA of serious adverse events associated with the use of products containing tianeptine.
The U.S. Centers for Disease Control and Prevention (CDC) warned in August that clinical effects of tianeptine abuse and withdrawal can mimic opioid toxicity and withdrawal. The CDC also reported there has been a rise in tianeptine exposure calls to U.S. poison control centers during 2014–2017, suggesting a possible emerging public health risk.
Tianeptine is approved to treat depression in other countries, and taking it can have significant health effects, including neurologic, cardiovascular, and gastrointestinal signs and symptoms, with some effects mimicking opioid toxicity and withdrawal.
Generally, if a product is marketed as a dietary supplement but claims to diagnose, mitigate, treat, cure or prevent a specific disease or diseases, then it is regulated as a drug. In addition, dietary supplements containing tianeptine are adulterated under the Federal Food, Drug, and Cosmetic Act because tianeptine is an unsafe food additive and should not be present in dietary supplements. The FDA has not approved tianeptine for any use.
According to the Substance Abuse and Mental Health Services Administration, patients receiving FDA-approved medication assisted treatments (MAT) for opioid dependence cut their risk of death from all causes in half. However, using products with unsubstantiated claims may prevent those addicted to opioids from seeking approved treatments that have been demonstrated to be safe and effective, delay their path to recovery, and put them at greater risk of death.
Health care professionals and consumers are encouraged to report any adverse events related to these products to the Safety Reporting Portal.
