Pharmaceutical

FDA raises concerns about herbal supplement kratom

kratom plant FDA raises concerns about herbal supplement kratomThe Food and Drug Administration (FDA) issued a Public Health Advisory due to its growing concerns about the risks associated with the use of the herbal supplement kratom, and is calling on those who believe in the potential medical benefits of the herb to conduct research on kratom so that its risks and benefits can be better understood.

Kratom is a plant indigenous to Thailand, Malaysia, Indonesia and Papua New Guinea. It has grown in popularity in the U.S., and is often marketed as a “safe” treatment for a variety of conditions. The FDA said it knows people are using kratom to treat conditions like pain, anxiety and depression, “which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider,” FDA Commissioner Scott Gottlieb, M.D., said in a statement.

Kratom has narcotic effects similar to opioids and as a result carries the same risk of abuse, addiction and, in some cases, death. “Thus, it is not surprising that often kratom is taken recreationally by users for its euphoric effects,” Gottlieb said, adding that kratom as an alternative or adjunct to opioid use is “extremely concerning” given the current opioid epidemic in the U.S.

“It’s very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms,” said FDA Commissioner Scott Gottlieb ,M.D. “There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder.”

Kratom can cause adverse events like seizures, liver damage and withdrawal symptoms. Calls to U.S. poison control centers have increased 10-fold from 2010 to 2015, and the FDA is aware that at least 36 deaths linked to kratom use. There have also been reports of kratom laced with opioids.

“Given all these considerations, we must ask ourselves whether the use of kratom – for recreation, pain or other reasons – could expand the opioid epidemic,” Gottlieb said. “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.”

There are currently no FDA-approved therapeutic uses of kratom, and no drug company has sought to properly develop a drug that contains kratom. Thus, before kratom can be legally marketed for therapeutic uses in the U.S., the botanical’s risks and benefits must be evaluated.

In the interim, the FDA has exercised jurisdiction over kratom as an unapproved drug, and has taken action against companies manufacturing and marketing dietary supplements containing kratom. These efforts include import alerts to prevent shipments of kratom from entering the U.S.

Kratom is already a controlled substance in 16 countries, and is also banned in several states including Alabama, Arkansas, Indiana, Tennessee, and Wisconsin. Several other states have pending legislation to ban the herb.

Source: FDA News Release