Kratom Products Can Kill You, FDA Says

Kratom Products Can Kill You, FDA Says

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.

Kratom is already a controlled substance in 16 countries, including two of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden, and Germany. It's taken recreationally for its euphoric effects, as a dietary supplement, to treat anxiety and depression, and more.

The regulator said there are now no approved therapeutic uses of kratom, which is linked to serious side effects such as seizures and liver damage.

Calls to US 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. "At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning".

The FDA said it is working to prevent shipments of kratom in the United States and has detained hundreds of these packages at global mail facilities.

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

Evidence suggests that kratom has similar effects to narcotics like opioids, and, according to Gottleib's statement, it has similar risks of abuse, addiction, and in some cases death, too. "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".

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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.

"Given all these considerations, we must ask ourselves whether the use of kratom-for recreation, pain or other reasons-could expand the opioid epidemic".

"I understand that there's a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders", Gottlieb added.

The herb is banned in several states, such as Indiana, Tennessee, Alabama, Arkansas and Wisconsin.

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

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

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