Tianeptine products voluntarily recalled following FDA letter to retailers
A company selling tianeptine – aka “gas station heroin” – has agreed to voluntarily recall all lots of three of its products after the Food and Drug Administration sent a letter to retailers, including convenience stores and gas stations, FDA announced.
In a Jan. 23 release, FDA revealed it continues to receive serious adverse event reports – including death, loss of consciousness and seizures – after consumers have used Neptune’s Fix products.
“These products may interact, in life-threatening ways, with other medications a consumer may be taking,” FDA warned. “The agency is actively investigating adverse event reports in conjunction with local and state health departments.”
Meanwhile, Neptune Resources LLC has agreed to voluntarily recall all lots of Neptune’s Fix Elixir, Fix Extra Strength Elixir and Fix Tablets, FDA announced.
FDA said it sent a letter on Jan. 11, urging convenience stores, gas stations and other retailers to stop selling tianeptine products. In the letter, which FDA made public in the release, the agency mentioned an earlier public safety alert in November that it issued after receiving reports of medical injuries linked to Neptune’s Fix, which is labeled to contain tianeptine.
“Tianeptine is not approved for any medical use in the United States and is often unlawfully labeled or sold as a dietary supplement,” the Health Fraud Branch of FDA’s Office of Regulatory Affairs (ORA) stated in the letter. “FDA continues to receive reports of consumers who have suffered seizures, loss of consciousness or other adverse health events after ingesting this product. We are reaching out because most consumers report purchasing this product at local gas stations or convenience stores across the country.”
At least 12 states have banned tianeptine sales, according to the letter. Citing the Centers for Disease Control and Prevention, ORA warned "the clinical effects of tianeptine abuse and withdrawal can mimic opioid toxicity/withdrawal."
FDA's letter was sent about a week before five members of Congress wrote to the head of FDA, asking what the agency was doing to address use of tianeptine.