New FDA warning about Neptune’s Fix pain supplements linked to seizures, death

The Food and Drug Administration (FDA) has recently issued a new warning regarding supplements containing the ingredient tianeptine, commonly referred to as “gas station heroin.” These products, known as Neptune’s Fix, can be found at gas stations, convenience stores, and online. The FDA has discovered that they are linked to severe side effects, including seizures, loss of consciousness, and even death.

Continuing Reports of Poisoning

Despite the initial warning issued by the FDA in November, reports of individuals being poisoned by these tianeptine-containing supplements are still being received. Tianeptine, an antidepressant approved in some European, Asian, and Latin American countries, is not authorized for use in the United States.

Serious Side Effects

According to the Centers for Disease Control and Prevention, tianeptine can cause adverse effects on the nervous system, heart, and stomach. Some of these effects mimic opioid toxicity and withdrawal. Illegally marketed in the US as a dietary supplement, retailers often claim that Neptune’s Fix can improve brain function, treat anxiety, depression, pain, opioid use disorder, and other conditions.

Life-Threatening Interactions

The FDA has been investigating serious reactions to these products, such as seizures and loss of consciousness leading to hospitalization. They emphasize that these supplements can interact dangerously with other medications that consumers may be taking. The FDA is actively collaborating with local and state health departments to investigate adverse event reports.

The Broken System

Dr. Pieter Cohen, an associate professor at Harvard Medical School specializing in supplement regulation, comments on the illegal sale of tianeptine, stating that it is evidence of a broken system. Dietary supplements in the US are not approved or reviewed by the FDA for safety and effectiveness. Consequently, the FDA’s tools to address these issues are extremely limited.

Voluntary Recall and State Bans

Neptune Resources, the manufacturer of Neptune’s Fix, has agreed to voluntarily recall its products, which include Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets. However, it remains unclear whether these products can still be found on store shelves. At least 12 states have already banned the sale of tianeptine due to its associated risks.

Urging Retailers to Stop Selling

In addition to the recall, the FDA has sent a letter to convenience stores, gas stations, and other retailers urging them to cease selling Neptune’s Fix and any other tianeptine-containing products. This action aims to protect consumers from potential harm.

The FDA’s latest warning coincides with House lawmakers’ call for FDA Commissioner Dr. Robert Califf to take action against the use of tianeptine. It is evident that the safety of consumers is at the forefront of concern.

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Note: This article is written with F5 Magazine in mind. For more information on health and wellness, visit F5mag.com.