An unapproved drug is making its way across the United States, feeding the addiction it claims to help and wreaking havoc in its wake.
As it circulates throughout the country, including Delaware, officials continue warning the public about the adverse effects of using the drug and urge communities to stay away from it. Tetramisole Hydrochloride
Here’s what you need to know.
Tianeptine, known as gas station heroin for its easy accessibility at local gas stations, is marketed as Coaxil or Stablon and is prescribed in some Latin American, Asian and European countries to treat depression and anxiety, according to the U.S. Food and Drug Administration.
In the U.S., tianeptine is not approved for medical use. The FDA classifies the drug as a substance that does not meet the statutory definition of a dietary ingredient and brands it an unsafe food additive.
Tianeptine is also known as:
The FDA reports that tianeptine has been sold in-store and online, typically in tablet or powder form.
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Tianeptine is not approved by the FDA for any medical use and is linked to serious health risks and even death, despite it being illegally sold with the claim that it will treat mental illnesses and opioid use disorder, improve brain function, ease pain or help other conditions.
While some countries have approved tianeptine use, others have restricted how it is dispensed and prescribed, or revised product labels to warn of the possible side effects and addiction risk.
According to the FDA, tianeptine is not generally recognized as safe, does not qualify as a dietary ingredient and is not an approved food additive, therefore making it adulterated under the Federal Food, Drug and Cosmetic Act.
“We have issued warning letters to companies illegally marketing tianeptine products as dietary supplements and unapproved drugs. We also have issued import alerts to help stop tianeptine shipments at our borders,” the FDA said. “The FDA will continue to take regulatory action to discourage the importation and marketing of unapproved tianeptine products.”
In the US, tianeptine is banned in Alabama, Florida, Georgia, Indiana, Kentucky, Michigan, Mississippi, Ohio and Tennessee.
The FDA reports that unwanted effects of and bad reactions to tianeptine are increasing, noting that poison control center cases involving tianeptine exposure have increased nationwide. The number of total cases jumped from 11 cases between 2000 to 2013 to 151 cases in 2020.
“People seeking to treat their ailments sometimes mistake products 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.”
From 2000 to 2017, 217 tianeptine exposures were documented, with 75 reported in the South, 54 in the West, 47 in the Midwest and 41 in the Northeast, according to the CDC.
The demographic most impacted by tianeptine exposure was 21- to 41-year-olds, followed by those between the ages of 41 and 60, those under 20 years old and those above 61 years old.
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The CDC reports that clinical effects of tianeptine abuse and withdrawal can mimic opioid toxicity and withdrawal, with neurologic, cardiovascular and gastrointestinal signs and symptoms possible.
Other effects of tianeptine exposure include:
People with a history of opioid use disorder or dependence may be at an increased risk of abusing tianeptine, especially if used with other drugs like antidepressants and anti-anxiety medicines, the FDA said.
The Poison Control Center at Children’s Hospital of Philadelphia announced on Feb. 7 that 15 cases of tianeptine use were documented from Feb. 1, 2023, to Jan 31, 2024, adding that “cases appear to be increasing since August 2023.”
The affected individuals were between 20 and 69 years old, with 87% of the cases identified as “male.” Of the 15 cases, three were documented in Delaware. Most of the affected individuals were placed on ventilators in the ICU, with one reported death.
On Feb. 8, the Delaware Division of Public Health posted on Facebook to raise awareness about tianeptine’s risks and offer support services, adding that the drug has been sold in counterfeit form to look like prescription opioids. The agency urges anyone who has taken tianeptine to call the Poison Control Center at (800) 222-1222 immediately.
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The FDA urges the public to avoid all products containing tianeptine, especially if they claim to treat a disorder or ailment and regardless of whether you are addicted to the drug or not.
“Reliance on products with unsubstantiated claims may delay those who suffer from opioid use disorder from entering recovery and may put them at greater risk of overdose and death. Consumers with OUD should consult their healthcare provider for treatment options,” the FDA said.
State-licensed providers who specialize in treating addiction and substance use disorders can be found by visiting www.findtreatment.gov or calling (800) 662-HELP (4357).
Adverse events involving tianeptine can be reported using the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by complete and submitting the report online. The form also can be downloaded – or mailed to you by calling (800) 332-1088 and requesting a reporting form be sent to you – and sent to the return address or faxed to (800)-FDA-0178.
For any questions about medication, call your pharmacist or the FDA. The FDA’s Division of Drug Information is available to answer drug questions by email, at druginfo@fda.hhs.gov. and by phone, at (855) 543-DRUG (3784) and (301) 796-3400.
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