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

The drug has been rising in popularity as an opioid alternative. "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". It's taken recreationally for its euphoric effects, as a dietary supplement, to treat anxiety and depression, and more. But it has addictive properties of its own, FDA says in a public health advisory related to the FDA's mounting concerns regarding risks associated with the use of kratom. But the DEA almost made kratom a Schedule 1 drug, the same as heroin and marijuana, last year, and the FDA is now trying to stop shipments of kratom from entering the U.S. while it works on increasing regulatory oversight. The DEA said last October it would delay a decision until the FDA issued a recommendation.

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.

Calls to USA 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.

For now, kratom is widely available online and in some stores.

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

The fact Gottlieb is speaking to the investigations staff is significant because "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", says Joshua Sharfstein, former principal deputy FDA commissioner in the Obama administration. That way the product can be assessed for its safety and effectiveness.

FDA is already using import alerts and other authority to stop foreign, unapproved and misbranded drugs at the border to keep kratom shipments from entering the United States. 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 said the agency has seized and destroyed shipments of kratom at worldwide mail facilities. Hundreds of shipments have been detained and product has been seized and destroyed.

The Drug Enforcement Administration had planned to ban the plant by adding it to a list of illegal drugs that includes marijuana, heroin and LSD.

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