The Food and Drug Administration (FDA) has issued an urgent warning to consumers about several products sold under the brand name Neptune’s Fix that contain the dangerous substance tianeptine, also known as “gas station heroin.”
Background on Tianeptine and Neptune’s Fix
Tianeptine is an antidepressant drug that works by affecting the brain’s opioid receptors. It has never been approved for medical use in the United States, but is available in some other countries by prescription to treat depression and anxiety.
However, tianeptine has also become popular in recent years as a recreational opioid alternative with effects similar to heroin or morphine. It has been increasingly sold illicitly at gas stations, smoke shops, and online under various brand names like Za Za, Pegasus, and Neptune’s Fix.
Neptune’s Fix produces several products marketed as “dietary supplements” that claim to relieve anxiety, improve mood, and provide an energy boost. However, laboratory testing has found extremely high levels of tianeptine in these products.
Recent CDC Investigation into Severe Illnesses
The urgent warning from the FDA comes after the Centers for Disease Control and Prevention (CDC) launched an investigation in January 2024 into a cluster of 23 cases of severe bleeding disorders in the state of Maryland.
The Maryland Department of Health found that 83% of the cases reported consuming tianeptine daily, often in the form of Neptune’s Fix products purchased from gas stations and convenience stores.
Many patients experienced symptoms like nausea, vomiting blood, and gastrointestinal bleeding. At least three people have died so far. The CDC determined that contamination with high amounts of tianeptine led to these severe illnesses.
FDA Issues Recall and Warns of “Serious Health Risks”
On February 1st, 2024, the FDA sent an official warning letter to Neptune Manufacturing & Distributing demanding an immediate recall of three of their “dietary supplement” products found to contain tianeptine – Neptune’s Fix VIVID Dreams, Neptune’s Fix Rocket Pop, and Neptune’s Fix Blue Magic.
The FDA stated that these products “may pose a serious health risk” due to the presence of tianeptine and are considered “adulterated” under federal laws. Consuming tianeptine can lead to addiction, withdrawal, overdose, and death according to health officials.
On February 2nd, Neptune Manufacturing & Distributing officially recalled all lots of these three products. The FDA is urging consumers not to purchase or use them.
Alarming Increase of Tianeptine Exposure Cases
In its health advisory, the CDC noted an alarming nationwide increase in calls to poison control centers related to tianeptine exposure.
The National Poison Data System recorded 457 exposure cases in 2022, up from just 11 cases in 2018. This represents a massive 4,000% increase over 4 years. About 25% of recent cases led to moderate or major health effects.
|Tianeptine Exposure Calls
The CDC advisory also pointed out that the real number of exposures is likely much higher since many people who use illicit substances may not report issues to poison control or seek medical care.
Health Risks and Side Effects
Tianeptine acts on the brain’s opioid receptors leading to addiction and withdrawal symptoms similar to other opioids like heroin or morphine. The euphoric high provides recreational appeal.
Consuming unknown amounts of tianeptine in products like Neptune’s Fix leads to unpredictable and dangerous effects. Even small amounts can negatively interact with other substances.
Reported health impacts include:
- Nausea, vomiting
- Abdominal pain
- Liver damage
- Bleeding disorders
- Respiratory depression
- Sedation, drowsiness
- Confusion, agitation
- Cardiac effects
- Kidney failure
The FDA has received over 300 reports of adverse events related to tianeptine-containing products over the last few years including deaths and life-threatening conditions.
Ongoing Investigations and Legal Action
Several government agencies at both state and federal levels continue to investigate the distribution of illicit tianeptine.
In September 2022, Customs and Border Protection officers seized a large shipment of tianeptine powder at an express consignment facility in Cincinnati. And in December 2022, authorities arrested 13 people in Alabama on charges related to the illegal sale of products containing tianeptine.
Some states have already passed laws or emergency rules to schedule tianeptine as a controlled substance to curb access and punish those profiting from sales. Public health experts expect more states and federal authorities to introduce similar regulations restricting tianeptine.
The FDA has also warned all manufacturers and retailers that selling fraudulent products labeled as “dietary supplements” that actually contain dangerous illicit compounds may lead to legal penalties including criminal prosecution.
With tianeptine poisoning cases rising rapidly across 30 states, officials expect the number of illnesses, hospitalizations, and deaths associated with “gas station heroin” to increase before stricter regulations eventually limit access.
The Drug Enforcement Agency will likely need to get involved and classify tianeptine as an illegal Schedule I drug federally like heroin or LSD. However, such actions tend to take many months.
In the meantime, public health agencies advise avoiding any products labeled as containing tianeptine or sold under brands like Za Za, Pegasus, or Neptune’s Fix which frequently include undisclosed amounts of the dangerous opioid-like substance. Seeking medical help quickly after consumption can reduce the chances of life-threatening effects.
The CDC and FDA also recommend disposing of any such products properly and reporting any adverse events to MedWatch so authorities can continue monitoring the situation and piecing together where and how it is being distributed. Identifying the source remains crucial to getting tianeptine off the streets for good.
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