FDA issues natural product formulation ‘Kratom’ public health warning

Although FDA is a natural product, the public health advisory related to kratom, which has become a problem in terms of safety, has been attracting attention since it has been used in recent years.

Kratom, which is known to be distributed as a natural supplement in the United States, is a type of plant native to Thailand, Malaysia, Indonesia, and Papua New Guinea.

It has been known that it is gaining popularity in the United States in recent years due to the wrong marketing of safe products. As it is a natural product, it has been distributed as an agent that improves pain, anxiety, and depression as the claim that it is safe.

However, on the same day, the FDA urged special attention that it has similar effects to narcotic drugs, can involve abuse, dependence, and reports of some deaths.

The FDA said, “Even in cases where kratom is consumed for pleasure, it has been known that there are few cases in which the use of kratom as a substitute or supplement is increasing in the reality that opioid epidemic is an issue. “It is a very concerned part.”

Moreover, the FDA has been overwhelmed by the growing number of consumers who mistakenly perceive Kratom as a product that can cure narcotic withdrawal syndrome. It is because there is no data that reliably proves that Kratom will be able to cure the problems of using the wrong narcotic drugs.

Nevertheless, many patients with narcotic drug dependence are ingesting kratom without even reliable instructions for use, and in this process, medical professionals are concerned about the risks or side effects of kratom drugs or the possibility of interaction with other drugs. The FDA has raised serious concerns that it has not been consulted.

On the other hand, he noted that data clearly showing the dangers of Kratom are increasing.

He added that the number of inquiries related to Kratom to the US Drug Addiction Management Center has increased tenfold during the period from 2010 to 2015.

In particular, the FDA emphasized that it was aware of cases of 36 deaths related to the consumption of kratom preparations. In addition, he explained that cases of severe side effects such as seizures, liver damage, and withdrawal syndrome after ingestion of kratom along with the distribution of kratom in narcotic preparations such as hydrocodone were received by the FDA.

In light of this reality, FDA said, we are at a point where we need to ask ourselves whether we should continue to consume Kratom for the purpose of getting pleasure or alleviating pain. The intake of Kratom’s can only result in further amplification of the current crisis of the spread of narcotic drugs.

The agency also recalled that no one company has gone through the legal process to develop Kratom as a drug. It has also been pointed out that there is no precedent for any FDA-approved therapeutic effects.

Accordingly, the FDA emphasized that it is taking steps to prevent the use of kratom-containing preparations as dietary supplements. To this end, the company has been actively seeking to prevent kratom preparations from being imported into the United States, and has revealed that it has caught large quantities of kratom drugs imported through international mail.

The agency also added that it is conducting a comprehensive evaluation of the two ingredients in Kratom at the request of the United States Drug Administration (DEA).

Meanwhile, Kratom has been designated as a controlled substance in 16 countries around the world, including Australia, Sweden and Germany, as well as Thailand and Malaysia.

In the United States, some states, such as Alabama, Arkansas, Indiana, Tennessee, and Wisconsin, are subject to regulation, and others are expected to be included in the near future.

Understand the risks

Reported health effects of kratom use include sensitivity to sunburn, nausea, itching, sweating, dry mouth, constipation, increased urination and loss of appetite. Kratom by itself isn’t related to fatal overdose, but commercial sorts of the drug are sometimes laced with other compounds that have caused deaths.

People who use kratom for long periods have experienced anorexia, weight loss, insomnia, dry mouth, frequent urination and constipation. Psychotic symptoms (hallucinations, delusion, and confusion) are reported at high doses. Like other opioids, kratom may cause dependence (feeling physical withdrawal symptoms when not taking the drug), and a few people have reported becoming hooked in to kratom. Withdrawal symptoms include: muscle aches, insomnia, irritability, hostility, aggression, emotional changes, runny nose and jerky movements.

In recent years, some people have used kratom as an herbal alternative to medical treatment in attempts to regulate withdrawal symptoms and cravings caused by addiction to other opioids or to other addictive substances like alcohol. There’s no scientific evidence that kratom is effective or safe for this purpose.