Commissioner Scott Gottlieb issued a statement warning about the risks associated with kratom.
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. Anita Gupta, an osteopathic anesthesiologist and licensed pharmacist, has expressed concern about an increase in the use of kratom among her chronic pain patients.
The FDA says kratom carries similar risks of abuse, addiction and in some cases, death, as opioids. The plant's euphoric affect, which is similar to narcotics such as opioids, has led to recreational use as an alternative to opioids.
Some patients with opioid addiction are using kratom to treat their addiction. "There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder".
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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.
"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. 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.
Additionally, the FDA said it has identified kratom products on two import alerts, and is working to prevent shipments of the substance from entering the US, as well as detained hundreds of shipments at worldwide mail facilities. "The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms". 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. On Tuesday, the FDA issued a public health warning saying there was no evidence that the herb kratom was effective in treating opioid addictions. "Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee, and Wisconsin and several others have pending legislation to ban it", Gottlieb stated. They must be put through a proper evaluative process that involves the DEA and the FDA. "In the meantime, based on the weight of the evidence, the FDA will continue to take action on these products in order to protect public health", Gottlieb said in the statement.
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