(CNN) — The U.S. Centers for Disease Control and Prevention has linked products containing the unapproved drug tianeptine, also known as “gas station heroin,” to a “cluster of serious illnesses” that may contain synthetic marijuana.
According to information, Neptune Resources, which manufactures some tianeptine products, has announced a nationwide recall. announcement Posted this week.
The company said its products were not linked to any reports of adverse events and sent a letter to all distributors and customers saying that all Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Extra Strength Elixir products Neptune's Fix Tablets is arranging the return of recalled products including lots.
“The product is being recalled because it contains tianeptine, an ingredient that has not been approved by the FDA for any medical use,” Neptune Resources said in a statement. “The presence of tianeptine makes the product an unapproved drug whose safety and efficacy have not been established and is therefore subject to recall.”
Tianeptine is an antidepressant prescribed in Europe, Asia, and Latin America to treat major depressive disorder, according to the U.S. Food and Drug Administration.
According to the FDA, tianeptine products can be illegally sold online and at gas stations in the United States as dietary supplements that purport to improve brain function and treat conditions such as anxiety, depression, pain, and opioid use disorder. It is said that there are many.
According to the CDC, products containing tianeptine are sold under several brand names, including Pegasus and Zaza.
The FDA caveat Consumers are advised not to purchase or use tianeptine products due to the serious risk of seizures, loss of consciousness, and death.
At least two deaths related to tianeptine products sold as dietary supplements have been reported to the FDA in recent years. data indicates.
“Neptune Resources LLC's distribution channels have not reported any adverse events from the use of the product,” the company said.
according to report Neptune Fix was the most commonly used product among tianeptine exposures reported to the New Jersey Poison Control Center in the second half of 2023, the CDC announced Thursday.
From June to November, the center received 20 exposure reports from medical facilities related to tianeptine use in 17 people, an “unusual spike” since the center's annual average number of cases is less than two. ”.
Of the 17 cases, 13 were admitted to the intensive care unit and seven required intubation, according to the report. No deaths were reported.
“All patients were reported to have altered mental status upon evaluation,” the report states.
Other complications reported in connection with unregulated tianeptine products include hypotension, seizures, and heart rhythm abnormalities such as tachycardia, according to the report. At least one person went into cardiac arrest.
Nine said they had previously used tianeptine. Six people took tianeptine with other substances, including alprazolam, kratom, tramadol, trazodone, and gabapentin.
Fourteen patients reported taking Neptune's Fix. Neptune's Fix contains tianeptine and caveine, a compound found in the kava plant that is used to promote relaxation.
Additionally, researchers said they analyzed at least two bottles of Neptune's Fix and found that they contained a synthetic cannabinoid receptor agonist (synthetic weed) that was not listed on the label. There is.
Synthetic cannabinoids are man-made mind-altering chemicals similar to those found in marijuana, but they can cause serious side effects that are different from marijuana.
Healthcare providers and consumers are required to report any adverse events or side effects related to tianeptine to FDA. med watch Safety Information and Adverse Event Reporting Program.
If you have questions about tianeptine or need emergency assistance, please contact Poison Help at 1-800-222-1222 or PoisonHelp.org.
CNN Wire
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