(Bloomberg) -- The top food and drug regulatory agency in the US is warning consumers to stop using a kratom product after it was linked to a death.
OPMS Black Liquid Kratom, a plant-extract drink that is sold online and in certain stores, shouldn’t be consumed, the US Food and Drug Administration said in an advisory issued on Friday. “OPMS Black Liquid Kratom has been linked to serious adverse health effects, including death,” according to the statement on the FDA’s website. The agency has not approved any drug products that contain kratom and has “serious safety concerns” about its use in supplements and foods.
Kratom, made from a Southeast Asian plant, is sold at bars, corner stores and online. Users report taking it to boost energy levels and relieve pain, but it can have addictive properties, especially in its more concentrated forms. The FDA continues to warn consumers not to use kratom, saying it can lead to liver toxicity, seizures and substance use disorder.
Optimized Plant Mediated Solutions, the maker of the product, has been sued by parents whose son died after he used one of its products.
Gwendolyn Payton, an attorney representing the owner of the OPMS trademark at Kilpatrick Townsend & Stockton, said the FDA’s announcement “was a surprise given the safety record of this product and the fact that no one from the agency ever reached out to us for information before issuing this warning.”
“We are going to challenge this warning, and are confident that once the agency receives correct information on this product and the science surrounding it, the agency will change its position,” Payton said in an email.
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Last year, a jury awarded $2.5 million to the family of Patrick Coyne, 39, who died in his home in Oregon after consuming a large amount of kratom. The product Coyne used before his death was marketed as a “miraculous cure-all with ‘absolutely’ no negative health effects, and no risk of overdose,” according to the lawsuit.
(Updates to include attorney comment and reference to lawsuit from last year.)
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