The US Food and Drug Administration (FDA) has issued a health warning regarding products containing tianeptine, which is often called “gas station heroin” because of its easy availability at gas station stores.
The FDA noted that tianeptine is associated with an increasing number of adverse events, including death, and called its use “a dangerous and growing health trend facing our nation,” especially for youth.
Other associated adverse events cited by the agency include coma, agitation, confusion, hypertension, respiratory depression, tachycardia, and vomiting.
“Historically, there has been a delayed recognition of fast-growing trends,” the FDA wrote in its warning letter. Although it is closely following tianeptine products’ distribution and sale, “it is critical that you appreciate the magnitude of the underlying danger of these products and disseminate information about it,” the agency added.
Interestingly, the product is licensed as an atypical antidepressant in some countries and is commonly prescribed for oral intake at 12.5 mg thrice daily. However, because higher doses can produce euphoria, its use has been restricted and a warning has been added to its drug label about possible addiction.
Tianeptine has not been approved by the FDA for any medical use in the United States, is not scheduled under its Controlled Substances Act, is not considered to be safe in food, and has not met regulations as a dietary ingredient.
“Nevertheless, tianeptine is being marketed as a ‘research chemical,’ a ‘nootropic’ cognitive enhancer, or a dietary supplement,” the agency reported.
In addition to gas stations, the product — which also goes by names such as Tianaa, Zaza, Neptune’s Fix, Pegasus, and TD Red — is often available at convenience stores, vape shops, and online retailers.
The FDA noted that unlike the 37.5 mg total daily dose amount recommended by countries that have approved the product, there have been reports of individuals in the United States ingesting doses from 50 mg to 10,000 mg.
So far, the agency has sent warning letters to companies that distribute and sell products that contain tianeptine and is taking steps to warn individuals about the drug’s potential severe adverse events. In addition, it has issued an import alert to help detain shipment of the products containing the drug at US borders.
The FDA recommended that healthcare professionals talk to patients about these products and encourage their avoidance. Tianeptine may not be identified in routine drug-screening panels.
Those who believe a patient is experiencing a related adverse event should contact PoisonHelp.org (External Link Disclaimer) and can visit the FDA’s MedWatch website to submit a report.