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What You Need to Know About Tianeptine 

Regulatory Differences Across Regions

Tianeptine is often marketed under names like Coaxil or Stablon and is prescribed in some countries to treat depression and anxiety. However, the regulatory landscape varies significantly across different regions. In many Latin American, Asian, and European countries, tianeptine is prescribed for certain mental health conditions. In the United States, the Food and Drug Administration (FDA) has not approved tianeptine for any medical use. This discrepancy can create confusion and a false sense of security among individuals seeking treatment for their ailments.

FDA Classification and Safety Concerns

The FDA classifies tianeptine as a substance that does not meet the statutory definition of a dietary ingredient and brands it as an unsafe food additive. Despite its illegal status, tianeptine is being sold online and in stores, often marketed with misleading claims that it can treat mental illnesses, opioid use disorder, and other conditions. This marketing strategy preys on the vulnerabilities of individuals who are desperate for relief and may not be aware of the potential dangers associated with unapproved drugs.

Health Risks and Symptoms of Abuse

The FDA and the Centers for Disease Control and Prevention (CDC) have reported increasing cases of tianeptine exposure, leading to serious health risks and even death. The clinical effects of tianeptine abuse and withdrawal can resemble opioid toxicity and withdrawal, with symptoms including high blood pressure, drowsiness, confusion, coma, cellulitis, fever, miosis, urinary retention, kidney failure, acidosis, muscle weakness, rigidity, and delusions. These symptoms can be life-threatening and require immediate medical attention.

Addictive Potential and Abuse Risks

The addictive potential of tianeptine is another significant concern. Individuals with a history of opioid use disorder or dependence may be at an increased risk of abusing tianeptine, especially if they use it in combination with other drugs like antidepressants and anti-anxiety medications. The drug’s ability to produce euphoria and alleviate withdrawal symptoms can make it particularly appealing to those struggling with addiction, further perpetuating their dependency and hindering their recovery efforts.

Recent Cases and Statistics

From February 2023 to January 2024, the Poison Control Center at Children’s Hospital of Philadelphia documented 15 cases of tianeptine use, three of which were in Delaware. The affected individuals ranged in age from 20 to 69 years old, with 87% of the cases identified as male. Most of these individuals required intensive care, with one reported death. These statistics highlight the urgent need for awareness and action within our community to address this growing threat.

FDA Regulatory Actions and State Bans

In response to the growing threat of tianeptine, the FDA has taken several regulatory actions to discourage its importation and marketing. The agency has issued warning letters to companies illegally marketing tianeptine products as dietary supplements and unapproved drugs. Additionally, the FDA has issued import alerts to help stop tianeptine shipments at U.S. borders. Tianeptine is banned in several U.S. states, including Alabama, Florida, Georgia, Indiana, Kentucky, Michigan, Mississippi, Ohio, and Tennessee. These bans reflect the recognition of the serious health risks associated with tianeptine use and the need to protect public health.

Reporting Adverse Events

It is important to report any adverse events involving tianeptine to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. By documenting these events, the FDA can monitor the safety of tianeptine and take appropriate regulatory actions to protect public health. Adverse events can be reported online, and the reporting form can also be downloaded or mailed to you by calling (800) 332-1088. Reports can be sent to the return address or faxed to (800)-FDA-0178.