FDA warns against use of kratom

Scott Gottlieb, MD
Scott Gottlieb

The FDA issued a warning today about the potentially fatal risks linked to kratom, a plant-based product from Asia that the agency said is used to treat medical conditions such as pain, anxiety and depression, and used recreationally for its euphoric effects.

“I want to be clear on one fact: There are currently no FDA-approved therapeutic uses of kratom. Moreover, the FDA has evidence to show that there are significant safety issues associated with its use,” FDA Commissioner Scott Gottlieb, MD, said in a statement, adding that kratom’s effects mirror those of opioids, and carries similar risks for abuse, addiction and in some cases, death.

“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. ... There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder,” Gottlieb said.

He stated that the FDA is also concerned about the rising numbers of “harmful unapproved products” like kratom crossing the U.S. border.

Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, and the FDA is aware of reports of 36 deaths associated with the use of kratom-containing products, according to Gottlieb, who also stated that there are reports of kratom laced with other opioids. Kratom use has been linked to serious side effects like seizures, liver damage and withdrawal symptoms, he said.

“Given all these considerations, we must ask ourselves whether the use of kratom — for recreation, pain or other reasons — could expand the opioid epidemic. Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits,” Gottlieb said.

In February 2014, the FDA issued an import alert that allowed U.S. officials to detain imported bulk dietary ingredients and dietary supplements that are, or contain, kratom without physical examination, according to a previous press release.

Disclosure: Gottlieb is FDA commissioner.

Scott Gottlieb, MD
Scott Gottlieb

The FDA issued a warning today about the potentially fatal risks linked to kratom, a plant-based product from Asia that the agency said is used to treat medical conditions such as pain, anxiety and depression, and used recreationally for its euphoric effects.

“I want to be clear on one fact: There are currently no FDA-approved therapeutic uses of kratom. Moreover, the FDA has evidence to show that there are significant safety issues associated with its use,” FDA Commissioner Scott Gottlieb, MD, said in a statement, adding that kratom’s effects mirror those of opioids, and carries similar risks for abuse, addiction and in some cases, death.

“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. ... There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder,” Gottlieb said.

He stated that the FDA is also concerned about the rising numbers of “harmful unapproved products” like kratom crossing the U.S. border.

Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, and the FDA is aware of reports of 36 deaths associated with the use of kratom-containing products, according to Gottlieb, who also stated that there are reports of kratom laced with other opioids. Kratom use has been linked to serious side effects like seizures, liver damage and withdrawal symptoms, he said.

“Given all these considerations, we must ask ourselves whether the use of kratom — for recreation, pain or other reasons — could expand the opioid epidemic. Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits,” Gottlieb said.

In February 2014, the FDA issued an import alert that allowed U.S. officials to detain imported bulk dietary ingredients and dietary supplements that are, or contain, kratom without physical examination, according to a previous press release.

Disclosure: Gottlieb is FDA commissioner.