FDA Warns Of Deaths Linked To Opioid-Like Kratom

Henrietta Brewer
November 15, 2017

Kratom is a common name for a plant that grows in several countries in Southeast Asia including Thailand, Malaysia, Indonesia and Papua New Guinea.

The regulator said there are now no approved therapeutic uses of kratom, which is linked to serious side effects such as seizures and liver damage. Calls to poison control centers regarding kratom have increased 10-fold from 2010 to 2015. "At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning".

Data show that there is harm associated with the use of kratom.

The drug is kratom, and despite failing to gain FDA approval, it continued to be available for sale online and in stores - including inside a vending machine in Arizona.

On Nov. 14, 2017, FDA Commissioner Scott Gottlieb, MD, issued a statement regarding the risk of using kratom.

Kratom, like opioids, is believed to relieve pain.

"FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold". It has gained popularity in the U.S.as a treatment for pain, anxiety and drug dependence.

But the FDA said Tuesday that kratom carries similar risks, including addiction and death, and the agency is working to block shipments.

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.

Past year the Drug Enforcement Administration planned to make kratom a Schedule I drug, a category that includes marijuana and LSD, but decided against it after an outcry of opposition.

"At global mail facilities, the FDA has detained hundreds of shipments of kratom".

Kratom is banned in Australia, Malaysia, Myanmar, and Thailand and in several USA states - Alabama, Arkansas, Indiana, Tennessee, and Wisconsin. While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighed appropriately against the potential for abuse.

"They must be put through a proper evaluative process that involves the DEA and the FDA".

"I understand that there's a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders", Gottlieb added.

Gottlieb said that the drug should be studied before people take it for any reason.

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