ibusinesslines.com
ibusinesslines.com November 20, 2017


FDA Warns Of Injury, Death With Herbal Supplement Kratom

15 November 2017, 02:07 | Melissa Porter

Ilana Panich Linsman for STAT

Ilana Panich Linsman for STAT

A pill that's been credited with delivering super-human strength, feelings of euphoria, powerful pain relief, and better focus has now been linked with 36 deaths, drawing a new warning from the Food and Drug Administration on Tuesday.

Kratom, which has been consumed in Southeast Asia for centuries, binds to the same opioid receptor as morphine - so it can treat pain. It's taken recreationally for its euphoric effects, as a dietary supplement, to treat anxiety and depression, and more. Kratom may cause seizures, liver damage and withdrawal symptoms. There have been 36 deaths reported in associated with the plant's use, according to the agency, and calls to poison control centers in the United States increased 10-fold from 2010-2015. Jessica Bardoulas of the American Osteopathic Association tells USA Today there's "anecdotal and scientific evidence indicating kratom could be an effective opioid alternative".

The drug is kratom, and despite failing to gain FDA approval, it continued to be available for sale online and in stores - including inside a vending machine in Arizona.

"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.

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

Last year, the US Drug Enforcement Administration announced its plans to name the substance a Schedule I drug, the most restrictive classification alongside heroin and LSD which restricts medical research.


The health regulator said kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in worst cases, death. "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".

More than 340 million shipments of kratom reach the USA each year, even though the FDA has seized hundreds more.

The FDA's chief, Scott Gottleib, asked Congress for more power and expanded resources to combat the opioid epidemic on Tuesday.

"While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound science and weighed appropriately against the potential for abuse", Gottlieb added. The DEA will review the FDA's assessment and make a determination, says DEA spokesperson Wade Sparks.

Dozens of web sites sell kratom, but the FDA said it would exercise its jurisdiction over the product as an unapproved drug.

Gottlieb said he was sympathetic but said distributors have to show that kratom does work as advertised.



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