FDA Warns Against Harmful Effects of Kratom

Ebony Scott
November 16, 2017

The FDA is aware that individuals have been using kratom to treat pain, anxiety, and depression, as well as for recreational purposes for its euphoric effects.

The supplement, kratom, made from a plant native to Southeast Asia, has gained popularity in the U.S.as a treatment for pain, anxiety and drug dependence. The FDA is trying to expand the development and use of medical therapy to assist those addicted to opioids, but the government has a mandate to make sure that treatments are safe and effective. (A representative from the association could not be reached on Tuesday.) STAT reporter Eric Boodman even found a kratom vending machine in a sub shop in Arizona.

Kratom can not be used to treat opioid withdrawal symptoms.

The Food and Drug Administration issued a public health advisory Tuesday about the use of kratom, a herbal supplement known to ease the side effects of opioid withdrawals that's linked to 36 deaths. The FDA said that some of the adverse risks of opioids also appear with kratom use, including "abuse, addiction and in some cases, death".

Additionally, the FDA said it has identified kratom products on two import alerts, and is working to prevent shipments of the substance from entering the USA, as well as detained hundreds of shipments at global mail facilities. It's also increasingly being used to treat opioid withdrawals, states the FDA, which warns of liver damage, seizures, addiction, and death.

The health risks associated with kratom have also been clearly established as seen with a 10-fold increase (from 2010 to 2015) in calls to US poison control centers regarding its use.

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"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", former principal deputy FDA commissioner under the Obama administration, Joshua Sharfstein, told the news site. In addition, they are not consulting with a healthcare provider about the substance's dangers, side effects, or possible interactions with other drugs.

The FDA has a team of medical reviewers in their Center for Drug Evaluation and Research that evaluates whether botanicals can be used as drugs.

"We have identified kratom products on two import alerts and we are working to actively prevent shipments of kratom from entering the U.S.", Gottlieb said.

"While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighted appropriately against the potential for abuse", he wrote.

In 16 countries, kratom is a controlled substance. Kratom, which has been banned in 16 countries and 5 USA states, has been labeled "unapproved" by the agency.

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