May 26, 2024

FDA Warns Against Neptune’s Fix Because of Serious Health Risks

The FDA is warning consumers not to buy or use Neptune’s Fix, a product that is marketed for pain relief, to improve brain function, and treat anxiety, depression, and opioid use disorder. The government has received reports of serious complications after the use of this product, including seizures and loss of consciousness. The product contains tianeptine, which is a substance that is not approved by the FDA for any medical use.

FDA Warns Against Neptune's Fix Because of Serious Health Risks

Tianeptine is considered an alternate to fentanyl and oxycodone. While some companies in this country are planning to seek FDA approval for this drug, that has not happened.

According to Consumer Reports, tianeptine-related calls to poison controls centers have “skyrocketed” since 2015. At least four people in the United States have died after using the drug, and almost two dozen have been hospitalized. That number is most likely higher, since many adverse events are never reported.

Consumer Reports charges that the FDA is not adequately cracking down on sales of tianeptine, especially since there are many more reports from other countries of illness and death linked to this substance. The FDA says that there is no “systematic way” of knowing what dietary supplement products are on the market, so they are playing catch-up.

Tianeptine was developed in the 1960s. It has similar effects to opioids. The product is often sold at gas stations, earning it the nickname “gas station heroin.” Some drug recovery experts say that tianeptine is addictive, just like opioids are.

There is no supplement registry in this country, which would require companies submit information about their product to the FDA before it is marketed. Lawmakers have proposed legislation to grant the FDA that power since 2011, but those bills never even came to a vote. The FDA could approve tianeptine as a prescription drug, which could limit consumer access to it.

Neptune’s Fix’s labels state that the product is made with tianeptine, but may contain other harmful ingredients that are not printed on the label, according to the FDA. This product can be purchased online and at gas stations, vape or smoke shops, and other locations.

The FDA is testing these products and will provide consumers with updates when more information is available.

If you ¬†used Neptune’s Fix or other products containing tianeptine and have experienced health issues, see your doctor. You can then report it to the FDA using their MedWatch Safety Information and Adverse Event Reporting Program.

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