FDA Warns Of Deaths Linked To Opioid-Like Kratom

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. "There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder".

As a result, the agency has begun seizing supplies of kratom and taking steps to prevent future shipments from being imported into the United States, the FDA says.

FDA commissioner Scott Gottlieb also plans to tell his agency's criminal investigations staff that he may ask Congress for more authority and resources to fight the opioid epidemic, according to remarks prepared for delivery Tuesday afternoon.

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".

Calls to USA poison control centers about kratom, which is made from a plant that grows in Asia, jumped tenfold from 2010 to 2015, according to the FDA.

Tablets of the opioid-based Hydrocodone at a pharmacy in Portsmouth, Ohio, June 21, 2017.

Users have opposed efforts to regulate the plant, saying it could be a safer alternative to opioid pain pills.

"The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider", Gottlieb said. Hundreds of shipments have already been detained and many are seized.

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The kratom plant grows naturally across Southeast Asia in the countries of Thailand, Malaysia, Indonesia and Papua New Guinea.

Meanwhile, a similarly troubling trend has been seen with kratom.

So far, no marketer has tried "to properly develop a drug that includes kratom", Gottlieb said.

Kratom remains legal under federal law although some states have banned the plant, including Alabama, Arkansas, Indiana, Tennessee and Wisconsin.

"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.

"There are now no FDA-approved therapeutic uses of kratom", said Gottlieb.

"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.

"To those who believe in the proposed medicinal uses of kratom", he wrote, "I encourage you to conduct the research that will help us better understand kratom's risk and benefit profile, so that well studied and potentially beneficial products can be considered". Since that time, the DEA has taken no action and says they are still in the review process.

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