The FDA

Sub­stance is used to ease pain, anx­i­ety and opioid with­drawal

The Washington Post - - FRONT PAGE - More at wash­ing­tonpost.com/ news/ to-your-health BY LAU­RIE MCGIN­LEY lau­rie.mcgin­ley@wash­post.com

has is­sued a warn­ing against the her­bal sup­ple­ment kratom, which has been linked to 36 deaths.

The Food and Drug Ad­min­is­tra­tion is­sued a strong warn­ing Tues­day to con­sumers to stay away from the her­bal sup­ple­ment kratom, say­ing reg­u­la­tors are aware of 36 deaths linked to prod­ucts con­tain­ing the sub­stance.

Con­sumers are in­creas­ingly us­ing the sup­ple­ment, which comes from a plant in South­east Asia, for pain, anx­i­ety and de­pres­sion, as well as symp­toms of opioid with­drawal. The herb also is used recre­ation­ally be­cause it pro­duces symp­toms such as eu­pho­ria. Pro­po­nents say it is a safe way to deal with chronic pain and other ail­ments, and some re­searchers are ex­plor­ing its ther­a­peu­tic po­ten­tial, in­clud­ing help­ing peo­ple over­come ad­dic­tions.

But in a state­ment, FDA Com­mis­sioner Scott Got­tlieb said there is no “re­li­able ev­i­dence” to sup­port the use of kratom as a treat­ment for opioid-use dis­or­der, and there are no other FDAap­proved uses for kratom.

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.” He said calls to U.S. poi­son con­trol cen­ters in­volv­ing kratom in­creased ten­fold be­tween 2010 and 2015, and the herb is as­so­ci­ated with side ef­fects in­clud­ing seizures, liver dam­age and with­drawal symp­toms.

Last year, the Drug En­force­ment Ad­min­is­tra­tion pro­posed tem­po­rar­ily plac­ing the drug into Sched­ule 1 of the Con­trolled Sub­stances Act, which ef­fec­tively would have banned its use. But the agency back­tracked af­ter a pub­lic out­cry and pres­sure from some mem­bers of Congress. It asked the FDA to ex­pe­dite a sci­en­tific and med­i­cal eval­u­a­tion — in­clud­ing whether kratom has any med­i­cal use — and a rec­om­men­da­tion for how to han­dle the com­pounds in kratom.

DEA spokesman Melvin Pat­ter­son said Tues­day that once the agency re­ceives the FDA’s re­port, it will de­cide whether kratom should be reg­u­lated as a con­trolled sub­stance and if so, into which sched­ule, or clas­si­fi­ca­tion, it should be placed.

The herb is banned in sev­eral states, in­clud­ing Alabama, Arkansas, In­di­ana, Ten­nessee and Wis­con­sin. Got­tlieb said the FDA is treat­ing kratom as an un­ap­proved drug and also has taken ac­tion against kratom­con­tain­ing di­etary sup­ple­ments. If the plant is use­ful in treat­ing var­i­ous con­di­tions, a man­u­fac­turer should go through the agency’s reg­u­lar dru­gap­proval process to prove the prod­uct is safe and ef­fec­tive, he added. Mean­while, the FDA is work­ing to pre­vent ship­ments of kratom from en­ter­ing he coun­try.

Jack Hen­ning­field, an ad­dic­tion spe­cial­ist who works at the drug pol­icy con­sult­ing group Pin­ney As­so­ciates, which has done work for the Amer­i­can Kratom As­so­ci­a­tion, said sur­veys have shown that peo­ple us­ing opi­oids to treat pain or sat­isfy an ad­dic­tion were able to stop us­ing them by drink­ing kratom tea. He said kratom's “over­all abuse po­ten­tial and risk of death isn’t any­thing close to nar­cotics like opi­oids”, and re­strict­ing or ban­ning the sub­stance could drive some peo­ple back to opi­oids or onto the black mar­ket to get kratom.

In a study last year for the Amer­i­can Kratom As­so­ci­a­tion, Hen­ning­field, also an ad­junct pro­fes­sor of be­hav­ior pol­icy at Johns Hop­kins, found that ef­fec­tively ban­ning kratom “is not war­ranted from a pub­lic health per­spec­tive and is more likely to cause pub­lic health prob­lems that do not ex­ist.”

The Amer­i­can Kratom As­so­ci­a­tion says on its web­site that kratom is not habit-form­ing, but if it is taken in high amounts over long pe­ri­ods of time, con­sumers may ex­pe­ri­ence a de­pen­dence sim­i­lar to caf­feine de­pen­dence.

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