Pharmaceutical

FDA says kratom is an opioid

ucm595628 375x187 FDA says kratom is an opioidThe herbal supplement kratom contains compounds that have properties similar to prescription opioid painkillers, and carries similar risks for abuse, addiction and serious health consequences, including death, the Food and Drug Administration (FDA) announced in a news release.

The agency said that its concerns about kratom are rooted in sound science and are in the interest in protecting public health, which is why the FDA has taken what it calls significant steps to advance the scientific understanding of this product and how it works in the body. As part of this effort, the FDA studied the chemical makeup of kratom at the molecular level to better understand how the supplement behaves inside the body and how it can potentially affect the brain.

Using this modeling platform, FDA scientists analyzed the chemical structures of the 25 most prevalent compounds in kratom and concluded that all of the compounds share the most structural similarities with controlled opioids, such as morphine derivatives.

The agency’s scientists also analyzed the chemical structure of these kratom compounds and confirmed that two of the top five most prevalent compounds are known to activate opioid receptors. “This new data provides even stronger evidence of kratom compound opioid properties,” the agency said.

The model also predicted that some of the kratom compounds may bind to the receptors in the brain and contribute to stress response that impact neurologic and cardiovascular function. This strengthens the agency’s previous warnings of serious side effects associated with kratom, including seizures and respiratory depression.

“Based on scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compound found in kratom, opioids,” the agency stated.

This is a heightened concern in light of the nation’s growing opioid epidemic, especially since kratom is not regulated as a prescription drug, like prescription opioids. Through the years, the FDA has been monitoring the use of kratom, and has placed kratom products on import alert to prevent them from entering the country illegally. The agency has also seized several kratom products. The U.S. is not alone in its actions against the supplement. Several other countries, states and cities have banned kratom from entering their jurisdictions.

Finally, the FDA cautioned about the growing number of deaths associated with kratom use. The agency reported in November 2017 that it had received 36 reports of death linked to kratom use. Since then, that number has jumped to 44.

“Taken in total, the scientific evidence we’ve evaluated about kratom provides a clear picture of the biologic effect of this substance. Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids,” the agency stated in its news release. “There is no evidence to indicate that kratom is safe or effective for any medical use. And claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous.”

Source: FDA News Release