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

FDA chief warns about kratom to treat opioid addiction

Leaves from the kratom tree, which grows in Southeast Asia and is distantly related to coffee plants, have been touted as a potential treatment for opioid withdrawal, among other conditions. "Before it can be legally marketed for therapeutic uses in the USA, kratom's risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with". According to Bloomberg Businessweek, the American Kratom Association-yes, it exists-has lobbied to have kratom recognized as "a safe alternative to legal and illegal opioids".

"Importantly, evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases, death". In his statement, he wrote that calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. 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.

Previous 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.

Instead, he said, the FDA is concerned that the use of kratom could actually "expand the opioid epidemic".

Later in 2016, the DEA asked that the FDA provide a scientific and medical evaluation of the drug.

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"There's clear data on the increasing harms associated with kratom".

In 16 countries, kratom is a controlled substance. But for now, no company has tried to properly develop a drug that includes 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.

FDA is already using import alerts and other authority to stop foreign, unapproved and misbranded drugs at the border to keep kratom shipments from entering the United States. The agency has already detained hundreds of packages at worldwide mail facilities. But the agency backtracked after public outcry and pressure from some members of Congress. Seizures, liver damage, and withdrawal symptoms have all been associated with kratom use.

"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.

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