Opioid Alternative FDA Warning

Kratom capsules are displayed on Sept. 27 in Albany, N.Y. Federal health authorities are warning about reports of injury, addiction and death with the herbal supplement that has been promoted as an alternative to opioid painkillers and other prescription drugs.

Last week, the federal Food and Drug Administration made headlines for issuing a strongly worded warning against kratom, a botanical supplement usually made from the powdered leaves of the Southeast Asian plant Mitragyna speciosa.

The plant, used as a traditional medicine in its native region, has crept into American and European markets over the past few years as an herbal supplement and recreational product. It produces stimulant and pain-relieving effects that are similar to those associated with traditional opioids, according to a 2012 article in the Journal of the American Osteopathic Association.

In Southeast Asia, the plant has been used for years as a substitute for opium, according to the National Center for Complementary and Integrative Health.

Proponents, such as the American Kratom Association, say that the botanical can increase energy, provide pain relief, and even treat conditions including depression, anxiety and opioid addiction without being habit-forming — “unless taken in extremely high doses for extended periods of time,” according to the organization’s website.

The FDA, though, thinks differently. A statement from Scott Gottlieb, the agency’s commissioner, warned that kratom “carries similar risks of abuse, addiction and in some cases, death” to narcotics such as opioids. The agency also stated that there have been 36 fatalities in the U.S. associated with kratom-based products, and that kratom-related calls to U.S. poison centers have increased 10-fold from 2010 to 2015.

It provided no details on whether those deaths stemmed from improperly high doses of the supplement or whether kratom was used in combination with other narcotics.

“Basically, what the agency is saying is that kratom behaves as an opioid and that it itself has troubling side effects,” said Lyndsay Meyer, a spokeswoman for the FDA. “We’re open to possible therapeutic benefits, but they need to be backed by sound science and weighed against the risks of the drug.”

So, is kratom a problem
in Maryland?

Currently, there is not strong evidence that Marylanders are misusing kratom to a large degree. From January 2010 to the start of November 2017, there were 27 kratom-related calls made to the Maryland Poison Center, according to Executive Director Bruce Anderson. In Frederick County, there were only two total calls — one in 2016 and one in 2017.

Anderson, however, was quick to stress that calls to the agency didn’t necessarily reflect overall use of the drug.

“Just because people aren’t calling us about these substances doesn’t mean that they aren’t being used,” he wrote in an email. “We can only report what gets called in to us.”

The Maryland Department of Health is also keeping a close eye on kratom, especially in light of the statewide opioid epidemic, said Dr. Jinlene Chan, the acting deputy secretary for Public Health. The plant is currently legal in Maryland, but — like the FDA — the department considers kratom to be an unapproved drug.

Is kratom available
in Frederick?

The product is currently available over the counter at Willie’s Smoke Shop and at Bradley’s Adult Video and Gift Outlet in downtown Frederick. A package of kratom capsules costs about $20.

Kratom is also easily accessible online. A quick Google search yields hundreds of vendors offering the product, sometimes at very low rates. While the FDA is working to stop and detain shipments of kratom into the U.S., according to Gottlieb’s statement, the plant is only illegal in a handful of states, including Alabama, Florida, Indiana, Arkansas, Wisconsin and Tennessee.

What does the
science say about
risks and benefits?

For federal agencies, including the FDA and Drug Enforcement Administration, the potential therapeutic benefits of kratom don’t outweigh its risks. Like narcotic opioids, the plant carries a serious chance of respiratory depression, seizures and withdrawal symptoms, Meyer said.

The DEA considered kratom such a risk that it announced plans to classify the botanical as a Schedule 1 drug in August 2016, a decision that was met with a massive outcry by advocates, including the American Kratom Association. By October, the administration postponed its plans and allowed for a period of public comment on the substance, according to spokeswoman Katherine Pfaff.

Studies of kratom by non-federal researchers offer a mixed picture on the risks and efficacy of the plant. Research on its use, especially in Western countries, is scarce, and there are only a few comprehensive reviews of existing data. One 2017 literature review in the Journal of Ethnopharmacology found that kratom was used most commonly for pain management or treating opioid addiction, but that little evidence exists on safe preparation or correct dosage.

A 2015 article in the journal BioMed Research International found that different preparations of kratom offered varying levels of active compounds. Kratom tea, for example, could be less potent than powder capsules, making it difficult to assess the toxicity of the plant.

Another 2016 literature review in the journal Brain Research Bulletin found that while kratom had serious adverse effects in Western countries, death or overdose reports were virtually nonexistent in Southeast Asia, where the plant is traditionally used.

For Michael Tims — the academic director of the herbal program at the Maryland University of Integrative Health — varying reports on the safety of kratom could be tied to the different preparations of the plant. Because kratom is not regulated, reported overdoses might be due more to adulterated products or extraction methods that differ from traditional ways of consuming the substance.

“There’s certainly something happening, but is it based on the toxicity of the herb or other cofactors? That’s what I want to know,” he said. “When you have people buying products off the shelf and self-treating, that’s probably where you’re more likely to see adverse effects.”

Rather than outright banning the drug, Tims also thought that more federal research should be conducted to evaluate the safety of kratom and establish better standards for dosing and consumption.

“What we don’t know is, what’s the effect of long-term use?” he added. “Do we need to be aware of herb-drug interactions that we’re not aware of because it hasn’t been part of mainstream use? I’m a strong believer that the FDA needs to do its job without politics, to do the epidemiological studies and work from there.”

Follow Kate Masters on Twitter @kamamasters.

Kate Masters is the features and food reporter for The Frederick News-Post. She can be reached at kmasters@newspost.com.

(15) comments

meonthissite

Prohibition has never worked! Patients will die without proper pain relief! Kratom hasn't killed a single person because the plant has a built in defense, you cannot take more of it because you will quickly reach a threshold where it will make you throw up to the point of dry heaving which is highly unpleasant. Once you have thrown it up, you cannot put it back into your system until 24 hours. It WILL not let you overdose!

Alibaba

FDA trying to make Kratom illegal to bring it under their umbrella to make more money, its all about it. They are not worry about people’s life or health. If they were, they would made cigars and alcohol illegal as well. They are more dangerous and addictive for people than anything else, why people still using them? They can not make enough money from selling hydrocodein, Mathdon or any other generic meds. Now its a best way to ban Kratom and pretending they will research over it to find the risks, then put a FDA stamps on products and sell it as legal drugs to own that money. There are lots of addictive products which they can ban it, but its not beneficial for them, thats why they don’t give any attention to them.

Honeybee2166

I read stories such as this and upsets me so much as well as makes me angry. Forgive ny long rant becauae this will be a long one. First of all like to say there are so many misinformed people and those same people put way too much faith in our doctors, government, medical community. Not to say they are all not to be trusted or bad doctors. There are many wonderful physicians. This opiate epidemic we hear so much about was created by the medical community. The opiate epidemic is not full of Herion junkies as so many think and sterotype patients. Some of you would be shocked to know your mail carrier, pastor, teacher, nurse, bank teller, plumber, sister, grandfather, mother, son, husband, wife, neighbor. Not everyone is a junkie. Most people that are wrapped into the evil chaos of this opiate epidemic started by doctor prescribing pain medication and as for me told by doctor surgery would not help or had low chance with high risk and that only way to treat me would be pain medication so then begins the road with opaites.
Let people have option to go natural and treat ourselves. They want to keep us on subxone, Methadone, pain meds.
Kratom has helped so many people .. tabacoo kills but the big tabacoo companies keep it legal.
All the booze served that destroys families....leave Kratom alone please

FormerPatriot

Kratom does NOT cause respiratory depression. That statement is absolutely FALSE. This is precisely why it is as safe as it is. If you take too much of an opioid, you die. That's a mistake that can never be fixed. If you take too much Kratom you throw up. You learn what works for you and don't take too much next time.

TigDig

Kratom was associated with deaths in that the deceased had kratom in their sysytem, only two coroners have listed kratom intoxication as the cause of death, and one of those cases had contraindicated Rx medications in their system, a heart condition, and a disease of the thyroid The other person died of hemorraghic pulmonary edema, which has never been reported in animals or humans in connection with kratom - it is theorized that perhaps he tried to snort the fine powder of kratom. Here's another article that shows that 6 deaths in California had other drugs at play. Kratom is incredibly safe compared to the 22,000 deaths from Rx opioids in 2015 alone. The claim of "36" deaths is over a period of years. Even if that number is correct, among millions of users each year, that is a tiny number compared to Rx and street opioids. Where is the evidence that shows kratom is linked to respiratory depression that Ms. Myers claims in the article? Kratom does not activate the protein beta arrestin which is responsible for respiratory depression, says Scientific American.
https://unitedstateskratomunited.wordpress.com/2017/11/12/review-of-ca-deaths-by-amy-hendricks-forensic-pathology-technician-for-ku/

priorparent

Government should focus more on alcohol addiction which is far more devastating than this harmless plant.

naturegirl

Absolutely! 88,000 deaths per year and every other commercial right now is one promoting drinking.

That Guy Garcon

I would just like to thank the fine people of the FNP for making sure to tell me where I can buy some of this here in Frederick. Bradley's, here I come!!! THANKS

jwhamann

Yup, my weekend's all planned now. Videos and Kratom...

Dwasserba

[thumbup]That Guy

naturegirl

I would also like to add that purchasing any botanical from a smoke shop is insane. Regulation is needed to ensure that the product is not tainted and is safe, however prohibition will cause a spike in opiate related deaths which is definitely not the answer.

naturegirl

Attacks on this plant have increased since people are using it to stop taking opiates verses replacing them with another highly addictive drug like Suboxone. Being a plant, it cannot have patents placed, thus providing no value for traditional companies to research and market. The effects of this plant are similar to that of a cup of coffee and the benefits are great. I was able to cease taking opiates and Suboxone with this PLANT that has been used for thousands of years in Asia. I have been clean for almost six years and would have died from opiates or misuse of Suboxone, which is truly just another opiate like substance. It is truly sad that we are in the midst of one of the worst drug epidemics in history and the government yet again wants to ban another plant that has provided relief and helped many in their recovery without the necessity of relying upon the government and over-priced pharmaceuticals!

threecents

I am very happy that this worked for you, but if this actually killed Americans, as the article says, then it should probably not be sold unregulated in video stores.

naturegirl

I agree. My second comment from this morning states we need regulation and not prohibition and that it is insane to buy a botanical from a smoke shop. :-)

threecents

You are right. The way our country handles drugs - both legal and illegal - is unbelievably mixed up. This distinction between natural products and "drugs" is ridiculous, but it is a foundation of our system. It is right up there with insurance tied to jobs and our so called war on drugs. It seems we are clueless.

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