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FDA Renews Warning Against Use of Tianeptine-Containing Products, aka “Gas Station Heroin”

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Reported adverse events of products with tianeptine include seizures, loss of consciousness, and death, according to the FDA.

FDA Renews Warning Against Use of Tianeptine-Containing Products, aka “Gas Station Heroin” / Image credit: ©MohamadFaisal/AdobeStock

©MohamadFaisal/AdobeStock

The US Food and Drug Administration (FDA) renewed its warning against the use or purchase of products containing tianeptine, which have been illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder, and other conditions.

The agency announced the follow-up warning in a January 23, 2024, press announcement, noting that it continues to receive adverse event reports linked to use of the products.

On January 11, 2024, the agency issued a letter to convenience stores, gas stations, and other organizations urging retailers to stop selling Neptune’s Fix and any other tianeptine-containing products—dubbed “gas station heroin”—after continuous reports of severe adverse events, including seizures, loss of consciousness, and death. According to the CDC, tianeptine abuse and withdrawal signs can mimic those of opioid toxicity and withdrawal.

At least 12 states have banned sales of tianeptine, according to the FDA.

“Tianeptine is not approved for any medical use in the United States and is often unlawfully labeled or sold as a dietary supplement,” stated the agency in the letter. “We are reaching out because most consumers report purchasing this product at local gas stations or convenience stores across the country.”

Following the letter, Neptune Resources, LLC, announced they would voluntarily recall “all lots of Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets to the consumer level.”

Neptune’s Fix labels state the product contains tianeptine, but it may contain other harmful ingredients not listed, according to the FDA. The products, which are also sold online and at vape and smoke shops, are currently being tested by the FDA, and more information will be released when it becomes available.

Health care professionals and consumers are advised to report adverse events or side effects related to the use of this product to MedWatch, the FDA’s Safety Information and Adverse Event reporting program, here.

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