The Food and Drug Administration Tuesday issued a strong warning to consumers to stay away from the herbal supplement kratom, saying regulators are aware of 36 deaths linked to products containing the substance.
Kratom is a naturally growing plant in Thailand, Malaysia, Indonesia and Papua New Guinea, and is being marketed as a "safe" treatment option for certain diseases, including opioid addiction, the FDA said. Serious side effects associated with kratom include seizures, liver damage, and withdrawal symptoms.
Specifically, Gottlieb noted, poison control centers received ten times more calls about kratom in 2015 than they did in 2010. But it has addictive properties of its own, FDA says in a public health advisory related to the FDA's mounting concerns regarding risks associated with the use of kratom. "It's probably easier to "do it yourself" with kratom ordered over the internet than find - if it's available - and pay for FDA approved, doctor supervised treatment".
"Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product's dangers, potential side effects or interactions with other drugs", he wrote.
Rather, he said, evidence shows that the herb has similar effects to narcotics like opioids, "and carries similar risks of abuse, addiction and, in some cases, death".
The fact Gottlieb is speaking to the investigations staff is significant because "if they find people here who are opening the gates to these drugs, there may be opportunities for the FDA to investigate at a high level", says Joshua Sharfstein, former principal deputy FDA commissioner in the Obama administration.
Last year, the US Drug Enforcement Administration announced its plans to name the substance a Schedule I drug, the most restrictive classification alongside heroin and LSD which restricts medical research.
The United States is in the grip of an opioid epidemic.
Kratom is banned in Australia, Malaysia, Myanmar, and Thailand and in several U.S. states - Alabama, Arkansas, Indiana, Tennessee, and Wisconsin. The agency states, however, that there is no reliable evidence that kratom can be used to treat opioid use disorder. Until someone does the science the agency is requesting, the FDA will attempt to prevent shipments of kratom from entering the US.
Gottlieb said that the drug should be studied before people take it for any reason.
More than 340 million shipments of kratom reach the US each year, even though the FDA has seized hundreds more.
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