FDA warns against use of tianeptine products due to serious adverse effects
The US Food and Drug Administration (FDA) is warning consumers against the use of products containing tianeptine, citing reports of serious adverse effects, including death, associated with the substance.
Tianeptine, an antidepressant prescribed in Europe, Asia, and Latin America, is not approved for use in the United States. However, it is often sold illegally online and at gas stations, vape shops, and tobacco stores under the guise of dietary supplements.
The FDA has received reports of side effects such as agitation, drowsiness, confusion, sweating, tachycardia, hypertension, nausea, vomiting, slow or stopped breathing, coma, and death associated with tianeptine products. Some people use tianeptine as an alternative to opioids or to self-treat anxiety or depression, posing a risk of serious health complications.
Neptune Resources, LLC, has voluntarily recalled all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets at the consumer level. However, the company has yet to comment on its products.
Lawmakers are urging the FDA to take immediate action on the use of tianeptine products and investigate the possibility of adding tianeptine to a schedule of drugs under the Controlled Substances Act. Reports from America’s Poison Centers indicate that nearly 400 exposures to tianeptine products were reported in 2023, with the number of cases increasing each year since 2019.
With the ease of availability of tianeptine products in the United States, experts warn of the substance’s potential for abuse, mimicking the effects of opioids and posing a significant risk to individuals struggling with addiction.
Health care professionals and consumers are encouraged to report adverse effects related to tianeptine to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. In case of emergency, Poison Help can be contacted at 1-800-222-1222 or PoisonHelp.org.
The FDA’s warning against the use of tianeptine products underscores the need for greater oversight and regulation to protect consumers from the potential dangers posed by these substances.