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FDA Warns Public of Products Containing Tianeptine

FDA Warns Public of Products Containing Tianeptine

FDA Warns Public of Products Containing Tianeptine

Products marketing as supplements that contain tianeptine could have dangerous or even deadly effects.

January 11, 2024

In November 2023, the U.S. Food and Drug Administration (FDA) raised additional concern over products that could be sold online and in convenience stores, gas stations and tobacco shops.

FDA is warning consumers to not purchase or use any Neptune’s Fix products, or any other product with tianeptine—a potentially dangerous substance that is not FDA-approved for any medical use but is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions.”

Tianeptine products have been linked to overdoses and in some cases death, according to the FDA. The FDA says that tianeptine is used as a prescription drug in some European, Asian, and Latin American countries, but is not approved as a drug in the United States.

New York Times article highlighted how the products are marketed as a dietary supplement but can mimic an opioid. Tianeptine can appear as a concentrated powder or an ingredient in products such as Tianaa, Zaza and Pegasus.

At least nine states have banned or severely restricted tianeptine: Alabama, Florida, Kentucky, Michigan, Mississippi, Tennessee, Georgia, Indiana and Ohio, according to Forbes.

Florida Attorney General Ashley Moody said in a press conference that the state is taking “immediate action to outlaw this dangerous substance … No one should buy, sell or use products containing tianeptine.”

Poison control center cases involving tianeptine exposure increased in the U.S. from 11 total cases between 2000 and 2013 to 151 cases in 2020, notes the FDA.

“Tianeptine is an emerging threat,” Kaitlyn Brown, clinical managing director of America’s Poison Centers, told the Times, adding, “We have people who are able to get a substance that’s not well regulated, that has abuse potential and that, in high doses, can cause similar effects to opioids, leading to really harmful outcomes.”

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