FDA Sounds Alarm on "Gas Station Heroin" Tianeptine, a Growing Threat

The head of the U.S. Food and Drug Administration (FDA) is raising serious concerns about a dangerous drug known as "gas station heroin," warning of its potential to cause significant harm, including death. FDA Commissioner Martin A. Makary recently issued a letter to colleagues, urging them to pay attention to what he describes as a "dangerous and growing health trend" impacting the nation, particularly its young people.

Makary highlighted an increasing number of adverse events linked to products containing tianeptine, a substance often referred to as "gas station heroin." These products are readily available in gas stations, convenience stores, vape shops, and online retailers, despite the fact that tianeptine is not approved by the FDA for any use.

"I am very concerned," Makary stated, emphasizing the urgent need to raise public awareness about this dangerous product and the serious and ongoing risk it poses to America’s youth. The availability and deceptive marketing of tianeptine-containing products have triggered alarm among health officials nationwide.

The products are typically sold under various names, including Tianaa, ZaZa, Neptune’s Fix, Pegasus, and TD Red, further complicating efforts to track and regulate their distribution. The deceptive labeling and easy accessibility make it challenging for consumers to discern the true nature of these products and the potential dangers they pose.

Makary affirmed that the FDA is actively monitoring the distribution and sale of products containing tianeptine but stressed the importance of disseminating information about the drug to fully grasp the magnitude of its inherent danger. Increased awareness among healthcare professionals, law enforcement, and the general public is crucial to mitigating the potential harm associated with tianeptine use.

Tianeptine is licensed and marketed in some countries as an atypical antidepressant. In countries where it is approved for this purpose, the typical prescribed dosage is 12.5 mg orally, three times per day. However, when taken in higher doses, tianeptine can produce euphoric effects, leading to its recreational use and abuse.

Recognizing the potential for addiction and harm, some countries have implemented measures to restrict the prescription and dispensing of tianeptine. These measures include revising product labels to include warnings about its addictive potential.

Despite these precautions in other countries, tianeptine is not currently listed as a controlled substance in the United States. This lack of regulation contributes to its easy availability and further increases the risk of misuse and adverse health consequences.

Tianeptine is frequently taken recreationally, often without an understanding of its potential dangers. Abrupt cessation of tianeptine use can lead to withdrawal symptoms similar to those associated with opioid withdrawal, including craving, sweating, and diarrhea. These withdrawal symptoms can be severe and may require medical intervention.

Adverse events associated with tianeptine ingestion can include a wide range of symptoms, such as agitation, coma, confusion, death, drowsiness, hypertension, nausea, respiratory depression, sweating, tachycardia, and vomiting. The severity of these adverse events underscores the serious health risks posed by tianeptine use.

In 2022, New Jersey health officials issued warnings about two products sold as dietary supplements in gas stations and online – Neptune’s Elixir and ZaZa Red – following a spike in illnesses linked to their use. These warnings highlighted the immediate danger posed by these readily available products.

Between June and November 2023, there were 20 reported cases of tianeptine causing "severe clinical effects" in New Jersey, as noted in a February 1 alert from the U.S. Centers for Disease Control and Prevention (CDC). These reported cases underscore the increasing prevalence and severity of tianeptine-related health issues.

In 2023, the FDA issued an alert warning of the dangers of Neptune’s Fix and any other product containing tianeptine. The agency reported receiving severe adverse event reports following the use of Neptune’s Fix products, including seizures and loss of consciousness requiring hospitalization.

The FDA has determined that tianeptine does not meet the statutory definition of a dietary ingredient and is considered an unsafe food additive. The agency has expressed concern about the numerous serious adverse event reports associated with tianeptine.

On January 28, 2024, Neptune Resources, LLC, the manufacturer of Neptune’s Fix, initiated a voluntary recall of its products due to the presence of tianeptine. However, experts caution that other products may also contain the drug, highlighting the need for continued vigilance and regulation.

Anyone who is using tianeptine or a product containing tianeptine and is experiencing withdrawal symptoms is urged to contact the National Poison Control Center at 1-800-222-1222 or seek emergency medical assistance. Early intervention can help mitigate the potential for severe health consequences.