FDA issues strong warning about kratom to treat pain, opioid addiction

FDA issues strong warning about kratom to treat pain, opioid addiction

In 16 countries, kratom is a controlled substance.

In the United States, there are no FDA-approved uses for kratom, which grows naturally in Southeast Asia. It has gained popularity in the USA, with some marketers touting it as a "safe" treatment with broad healing properties.

Since then, there have been reports of 36 deaths linked with the use of products containing kratom; it can cause serious side effects including seizures and liver damage, and can even trigger symptoms of withdrawal when use is stopped, according to the FDA. We also know that this substance is being actively marketed and distributed for these purposes. Because it produces symptoms, such as euphoria, similar to opiates, it is also used recreationally. It has this effect because its active ingredients, mitragynine and 7-hydroxymitragynine, bind to the opioid receptors in our body, Boyer said, but unlike opioid drugs such as hydrocodone or heroin, it doesn't appear to slow breathing.

These two uses are what Gottlieb appears to see as the most troubling. The FDA is devoted to expanding the development and use of medical therapy to assist in the treatment of opioid use disorder.

Last year, the Drug Enforcement Administration proposed banning the use of kratom. Anita Gupta, an osteopathic anesthesiologist and licensed pharmacist, has expressed concern about an increase in the use of kratom among her chronic pain patients.

Instead, he said, the FDA is concerned that the use of kratom could actually "expand the opioid epidemic". "But the FDA has a science-based obligation that supersedes popular trends and relies on evidence", he wrote. We have issued guidance on the proper development of botanical drug products. It asked the FDA to expedite a scientific and medical evaluation and a recommendation for how to handle the compounds in kratom.

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

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The commissioner stressed the need to evaluate the drug's potential benefits and harms.

"This is especially relevant given the public's perception that it can be a safe alternative to prescription opioids", he added.

Gottlieb said the FDA is treating kratom as an unapproved drug and also has taken action against kratom-containing dietary supplements. Until someone does the science the agency is requesting, the FDA will attempt to prevent shipments of kratom from entering the US.

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".

Kratom is banned in Australia, Malaysia, Myanmar, and Thailand and in several USA states - Alabama, Arkansas, Indiana, Tennessee, and Wisconsin.

Kratom is an unapproved substance touted as a treatment for depression, pain, anxiety and even opioid addiction.

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