FDA Warns About Risks of Tianeptine Use in Dietary Supplements

Federal regulators are warning consumers not to be fooled by the illegal marketing of certain products containing tianeptine, such as Coaxial, Stablon or Tianna, which are not officially approved by the FDA since they are dietary supplements, yet may result in overdoses, serious injuries and deaths.

The U.S. Food & Drug Administration (FDA) posted an update about the tianeptine risks this month, alerting the public about dangers associated with products that are marketed as treatment alternatives for depression and anxiety.

According to the agency, tianeptine is often marketed as a dietary supplement capable of improving brain function and treating various ailments, from pain and anxiety to opioid use disorder. However, the FDA warns the drug is associated with serious health risks, including death.

Tianeptine is not approved by the FDA for any medical use. However, products containing the addictive and potentially deadly drug are still being illegally marketed by companies online under the names “Coaxial” or “Stablon”. It has also been found for sale in convenience stores and gas stations as a dietary supplement under names like “Tianna”, “Tianna Green”, “Tianna Red”, and “Tianna White”.

Belonging to a class of medications known as “opioid receptor agonists”, Tianeptine’s effect on the brain is very similar to other opioids like oxycodone, hydrocodone, methadone, and heroin. In essence, the drug supposedly provides increased pain relief and feelings of euphoria, but with severe side effects that include addiction and respiratory depression, much like the other more widely known opioids in its class.

According to the FDA, some Americans have sought this drug out as a readily available alternative to opioids or to self-treat anxiety and depression.  People with a history of opioid use disorder or dependence could be at a higher risk of abusing tianeptine due to its similarly addictive and euphoric effect.

Abuse and misuse of the illegal medication can result in severe side effects that include confusion, rapid heartbeat, elevated blood pressure, nausea, slowed or stopped breathing, coma and death.

Since the FDA first warned consumers about the dangers of tianeptine in November 2018, there has been a marked and steady rise in reported adverse reactions and unwanted tianeptine side effects across the country. According to the FDA “poison control center cases involving tianeptine exposure have increased nationwide, from 11 total cases between 2000 and 2013 to 151 cases in 2020 alone.”

The FDA warns consumers to avoid all products containing tianeptine. This includes those claiming to treat an ailment or disorder.

Consumers can report adverse events involving tianeptine by using the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.