Monday, 20 November, 2017

FDA chief warns about kratom to treat opioid addiction

Unproven benefits Unproven benefits
Patty Aguilar | 14 November, 2017, 23:33

The drug has been rising in popularity as an opioid alternative. Some chemists figure it's a promising starting point for new, less addictive painkillers. "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 August 2016, the Drug Enforcement Agency moved to make kratom a Schedule I drug, a substance that has "no now accepted medical use and a high potential for abuse". After a public outcry, the DEA chose to postpone its decision, and asked the FDA to weigh in.

Over the past several years, a botanical substance known as kratom has raised significant concerns given its increasing prevalence and potential safety risks. To date, the FDA has noted 36 deaths associated with kratom-containing products; there have also been reports of kratom laced with other opioids (eg, hydrocodone). He said that calls to US poison control centers involving kratom increased 10-fold between 2010 and 2015, and that the herb is associated with side effects including seizures, liver damage and withdrawal symptoms. "It's probably easier to "do it yourself" with kratom ordered over the internet than find - if it's available - and pay for FDA approved, doctor supervised treatment".

Importers, organized crime or others in the supply chain could be part of conspiracies to distribute illegal opioids, Sharfstein says.

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. It's taken recreationally for its euphoric effects, as a dietary supplement, to treat anxiety and depression, and more.

If companies want to market kratom for its supposed health benefits, they should go through the FDA's drug review process, Gottlieb said. To date, no marketer has sought to properly develop a drug that includes kratom.

The United States is in the grip of an opioid epidemic. It asked the FDA to expedite a scientific and medical evaluation and a recommendation for how to handle the compounds in kratom. To fulfill our public health obligations, we have identified kratom products on two import alerts and we are working to actively prevent shipments of kratom from entering the U.S. At global mail facilities, the FDA has detained hundreds of shipments of kratom.

"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. The DEA will review the FDA's assessment and make a determination, says DEA spokesperson Wade Sparks.

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