July 19, 2018

FDA Warns Against Harmful Effects of Kratom

The FDA is warning consumers about the risks of consuming kratom, which is an ingredient in dietary supplements that is sold as a treatment for depression, pain, and anxiety. First, those conditions are serious medical issues that should be diagnosed and managed by a licensed healthcare provider. And second, this substance can be addictive and has been linked to deaths.

 

warning recall signKratom is a plant that grows in Thailand, Malaysia, Indonesia, and Papua New Guinea. Supporters say that it’s natural because it’s a natural product. But it has effects similar to opioids, such as codeine and morphine, and can lead to abuse, addiction, and death.

Kratom is often taken recreationally by users for euphoric effects. There is an opioid epidemic in this country, and officials say that the increasing use of this plant as an alternative to opioid drug use is disturbing.

This substance is being actively marketed to treat medical conditions. Because of this, the FDA released a public health advisory about this product.

Kratom cannot be used to treat opioid withdrawal symptoms. The FDA is trying to expand the development and use of medical therapy to assist those addicted to opioids, but the government has a mandate to make sure that treatments are safe and effective. There is “no reliable evidence to support the use of kratom as a treatment for opioid use disorder,” according to the public health advisory.

People who are addicted to opioids are using kratom without any dependable instructions for use. In addition, they are not consulting with a healthcare provider about the substance’s dangers, side effects, or possible interactions with other drugs.

The FDA has data on the harm associated with consuming this substance. Calls to U.S. poison control centers about this substance have increased 10-fold from 2010 to 2015. The FDA knows of reports of 36 deaths associated with the use of products containing kratom, and has reports of kratom laced with other opioids such as hydrocodone. This use is also associated with serious side effects such as seizures, withdrawal symptoms, and liver damage.

The FDA has a team of medical reviewers in their Center for Drug Evaluation and Research that evaluates whether botanicals can be used as drugs. The advisory states, “To date, no marketer has sought to properly develop a drug that includes kratom.”

There are no FDA-approved therapeutic uses of kratom. And the FDA has evidence to show that there are “significant safety issues associated with its use.”

The FDA has taken action against companies that use this substance in dietary supplements and has seized products. Kratom products have been put on import alerts. Officials are working to prevent shipments from entering the U.S., and government officials have seized hundreds of shipments at international mail facilities.

Kratom is a controlled substance in 16 countries, including Thailand, Malaysia, Australia, Sweden, and Germany. And Alabama, Arkansas, Indiana, Tennessee, Wisconsin, and other states have legislation pending to ban it.

The warning ends with these words: “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. They must be put through a proper evaluative process that involves the DEA and the FDA.”

 

 

 

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