FDA warns of 'deadly risks' of the herb kratom, citing 36 deaths

Ilana Panich Linsman for STAT

Ilana Panich Linsman for STAT

The U.S. Food and Drug Administration warned on Tuesday about the usage of kratom, citing reports of 36 deaths, and said there is no reliable evidence to support its use to treat opioid withdrawal symptoms.

Kratom has similar effects to narcotics like opioids and carries similar risks of abuse, addiction and in worst cases, death, the FDA noted. "From the outset, the 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".

The FDA public health advisory on kratom follows the Drug Enforcement Administration's reversal or at least delay of plans to classify kratom as a controlled substance on the same level as heroin and LSD.

Along with opioid withdrawal, kratom is also believed to relieve fatigue, pain, cough and diarrhea. Marketers have been selling kratom, a plant grown in parts of Asia, as a treatment for a variety of conditions including pain, anxiety, and depression. The DEA had planned to list kratom as a schedule 1 drug, which means it is a drug with no now accepted medical use and a high potential for abuse. The FDA evaluated 2 compounds found in kratom, according to the statement however, there was no mention of the evaluation's outcomes in the statement.

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

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.

Gottlieb said the FDA is treating kratom as an unapproved drug and also has taken action against kratom-containing dietary supplements. "Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed healthcare provider about the product's dangers, potential side effects, or interactions with other drugs", Gottlieb said in the statement.

Still, more than 340 million packages reach the US every year.

"We've learned a tragic lesson from the opioid crisis: that we must pay early attention to the potential for new products to cause addiction and we must take strong, decisive measures to intervene", Gottlieb said.

Some patients with opioid addiction are using kratom to treat their addiction.

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