Friday, 14 December, 2018

FDA raises concerns about use of kratom for opioid addiction

Melissa Porter | 15 November, 2017, 02:09

The Food and Drug Administration has issued a public health warning about kratom, an herbal supplement used by some to treat chronic pain, help with opioid withdrawals, and is used recreationally.

Kratom, a plant grown naturally in countries including Thailand and Malaysia, is widely sold in smoke shops and other locations as a powder that can be used in tea to slow the effects of opioid withdrawal. "Calls to USA poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year", said FDA Commissioner Dr. Scott Gottlieb in a statement.

Some people think kratom is safe because it comes from a plant - it's a relative of coffee - but many poisons come from plants, including opioids, cyanide and ricin.

According to Gottlieb, there is clear data on the increasing harms associated with kratom. However, drugs made from these leaves carry "deadly risks", FDA Commissioner Scott Gottlieb warned in a statement on Tuesday afternoon.

"Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product's dangers, potential side effects or interactions with other drugs", he wrote.

It's listed as an unapproved drug by the FDA and has effects similar to opioids.

The FDA said that some of the adverse risks of opioids also appear with kratom use, including "abuse, addiction and in some cases, death".

Still, Jessica Bardoulas of the American Osteopathic Association said many "were dismayed to learn of the DEA's plan to classify the plan as a Schedule 1 substance. despite anecdotal and scientific evidence indicating kratom could be an effective opioid alternative". The FDA says that review is underway.

Meanwhile, a similarly troubling trend has been seen with kratom. Instead, Gottlieb mentioned that kratom is already a controlled substance in 16 countries, and that several states have pending legislation to ban it.

"At worldwide mail facilities, the FDA has detained hundreds of shipments of kratom". Last year, the Drug Enforcement Administration stepped back from taking action pending an FDA review.

"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.

"They must be put through a proper evaluative process that involves the DEA and the FDA".

"We've learned a tragic lesson from the opioid crisis: that we must pay early attention to the potential for new products to cause addiction and we must take strong, decisive measures to intervene", said Gottlieb in his prepared remarks.