2023 FDA Science Forum
Tianeptine Product Adverse Event Reports from the FDA CFSAN Adverse Event Reporting System
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Contributing OfficeCenter for Food Safety and Applied Nutrition
Abstract
Tianeptine is an antidepressant drug used in some European, Asian, and Latin American countries but it is not approved for any use by the U.S. Food and Drug Administration (FDA). In 2018 and 2022, FDA alerted consumers about tianeptine being used as an ingredient in products marketed as dietary supplements stating that tianeptine is a substance that does not meet the statutory definition of a dietary ingredient and is an unsafe food additive. The alert also provided information about the safety risk of tianeptine use. Even with FDA warnings, vendors continue to market and sell these products under a variety of names (e.g. Tianaa, Tianeptine sulfate, ZaZa Red, and Pegasus). The FDA Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS) is a post-market surveillance system that receives and monitors adverse event (AE) and product complaint (PC) reports for foods, dietary supplements, and cosmetics. CAERS has received a total of 35 reports involving tianeptine products since 2015. In 2022 alone, CAERS received more reports than the previous three years combined, with 15 reports. Analysis of the 35 reports revealed that the age of those reporting tianeptine product use ranges from 22 to 57 years old with most reporters being male (83%). The adverse events reported following tianeptine use included anxiety, cardiac disorder, dependence, depression, nausea, and withdrawal. The CAERS reports concerning tianeptine mentioned outcomes of death (2), hospitalizations or healthcare sought (11), life threatening situations (14), and other serious outcomes. Of the 35 reports, 27 (77%) included psychiatric disorders in the reported Medical Dictionary for Regulatory Activities (MedDRA) System Organ Classes (SOCs). Tianeptine is not approved for any medical use, or as a food additive, is not generally recognized as safe and does not qualify as a dietary ingredient. Consumption of these products can result in serious health outcomes. CAERS provides a vital surveillance role while FDA continues to monitor these products and take regulatory actions to protect the public from unapproved tianeptine products.
