Ohio Governor Mike DeWine signed Executive Order 2022-17-D on Thursday, to suspend the normal rule making process to allow the State of Ohio Board of Pharmacy to classify all products containing tianeptine, as a Schedule I controlled substance.
According to the Federal Drug Administration (FDA), tianeptine is an antidepressant drug that is not approved by the United States for medical use. The FDA warned that many companies are illegally marketing and selling products containing tianeptine to the public with unproven beneficial claims (i.e., dietary supplement, treatment for anxiety, depression, or opioid disorder).
Effective on Thursday, no one may sell or possess any product containing tianeptine in the state of Ohio.
The FDA issued a consumer update on tianeptine products in February 2022. The update states that tianeptine products link to serious harm, overdoses, and death. In the update, the agency continues to say it has found cases where individuals experienced other harmful effects from abusing or misusing tianeptine alone or in combination with other drugs such as antidepressants and anti-anxiety medications. Symptoms noted included agitation, drowsiness, confusion, sweating, rapid heartbeat, high blood pressure, nausea, vomiting, slowed or stopped breathing coma, and death.
Europe, Asia, and Latin America have approved the drug tianeptine, also marketed as Coaxil or Stablon. In the United States, users can easily obtain tianeptine, also called ZaZa and Tianna Red from gas stations, convenience stores, and online.
According to Psychiatrist Dr. Domenick Sportelli, countries in Europe that prescribe tianeptine as an antidepressant use a dose that is 60 times less potent than what is available over the counter in the United States. These high doses are incredibly dangerous.
“When you activate that opioid receptor in your brain with an opioid agonist which is what this is at high doses you decrease respiratory drive, which means your basically telling your brain that you don’t need to breathe. You’re increasing your blood pressure, your heart rate can become irregular, people go into comas, people even, unfortunately, pass away this is really really something that has to be taken seriously,” Sportelli said.
After an investigation of all available information on the drug, the State of Ohio Board of Pharmacy found that tianeptine has no accepted medical use in treatment in the state of Ohio, and it poses an impending hazard to the public, health, safety, and welfare.
In determining whether a previously unscheduled compound, mixture, preparation, or substance poses an imminent hazard to the public health, safety, or welfare, the board considers a drug’s actual or relative potential for abuse, the scope, duration, and significance of that abuse, and the risk it poses to the public health.
The Drug Enforcement Administration (DEA) defines Schedule I drugs, substances, or chemicals as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote.
The Center for Disease Control (CDC) reported in 2018 that tianeptine exposure calls to U.S. poison control centers increased during 2014–2017, suggesting a possible emerging public health risk. The associated health effects included neurologic, cardiovascular, and gastrointestinal signs and symptoms, with some effects mimicking opioid toxicity and withdrawal.
The State of Ohio Board of Pharmacy advises any business proprietor who finds tianeptine on their shelves should immediately remove and dispose of it.
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Hannah Poling is a lead reporter at The Ohio Star and The Star News Network. Follow Hannah on Twitter @HannahPoling1. Email tips to [email protected]
Photo “Mike DeWine” by Mike DeWine. Background Photo “Ohio Statehouse” by Niagara66. CC BY-SA 4.0.