The U.S. FDA issued a warning against the use of illegally marketed antidepressant tianeptine, saying the product is linked to severe harm, overdose, and even death.
Consumers must avoid using any medicine that contains tianeptine, the regulator noted.
In Korea, tianeptine is available as a prescription drug in recognition of its effectiveness in major depressive disorder.
Whether the FDA’s warning will prompt the Ministry of Food and Drug Safety to release safety measures draws attention.
According to the FDA, tianeptine is readily available online, although the regulator did not authorize it for any medical use. Despite that, some companies are illegally marketing and selling it.
“People seeking to treat their ailments sometimes mistake a product as being safe because it’s easily available, whether online or even at gas stations,” the FDA said. “But availability is no indication of effectiveness or safety. This is especially true of tianeptine, an unapproved drug associated with serious health risks and even death.”
Although tianeptine was not approved for medical use, some companies made unproven claims that tianeptine could improve brain function and treat anxiety, depression, pain, opioid use disorder, and other conditions, the FDA added.
The FDA pointed out that reports of adverse reactions involving tianeptine were increasing. Poison control center cases related to tianeptine use have gone up from 11 between 2002 and 2013 to 151 in 2020 alone, it said.
The FDA emphasized that tianeptine had safety risks and potential for abuse.
Medical journals, poison control centers, and reports to the FDA indicated that tianeptine was likely to be abused. It is said that this risk is more significant for people with a history of opioid use disorder or dependence.
The regulator also confirmed cases where people experienced severe harmful effects from abusing or misusing tianeptine alone or with other drugs, including antidepressants and anti-anxiety medications.
Those cases included agitation, drowsiness, confusion, sweating, rapid heartbeat, high blood pressure, nausea, vomiting, slowed or stopped breathing, coma, and death.
“Consumers should avoid all products containing tianeptine, including those claiming to treat an ailment or disorder,” the FDA said. If they need help with opioid dependence, depression, anxiety, pain, or other ailments, they need to talk to their healthcare providers, it added.
The FDA issued warning letters to companies illicitly selling tianeptine as dietary supplements, unapproved drugs, and import alerts.
In Korea, tianeptine-containing drugs are used as authorized prescription medications to treat major depressive disorder.
According to the Korean government’s drug data, 24 pharmaceutical products contain tianeptine. Among them, two are raw materials, and 15 out of 22 finished goods are generic drugs bundled in one.