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Kratoms FDA Warning

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FDA Warns of Herb Kratom’s Opioid-Like Harms

 

TUESDAY, Nov. 14, 2017 (HealthDay News) — The U.S. Food and Drug Administration on Tuesday issued an advisory about harms tied to kratom — an imported herbal supplement with opioid-like effects that is increasing in popularity.

 

People are taking the unapproved supplement to treat conditions like pain, anxiety and depression — without medical supervision, FDA Commissioner Dr. Scott Gottlieb said in a statement. Others use kratom for its euphoric effects, or to wean addicts off opioids such as prescription painkillers or heroin, also without medical say-so.

 

“Importantly, evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and, in some cases, death,” Gottlieb said. “At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning.”

 

The United States is in the grip of an opioid epidemic. Since 2000, more than 500,000 Americans have died from a narcotic overdose, according to the U.S. Centers for Disease Control and Prevention. President Donald Trump recently declared the crisis a public health emergency.

 

Meanwhile, a similarly troubling trend has been seen with kratom. Between 2010 and 2015, kratom-related calls to U.S. poison control centers jumped 10-fold. And 36 deaths have been linked to kratom-containing products. Kratom use can also cause seizures, liver damage and withdrawal symptoms, the FDA said.

 

In the United States, there are no FDA-approved uses for kratom, which grows naturally in Southeast Asia.

 

In some cases reported to the FDA, kratom is laced with opioids like hydrocodone (Vicodin), Gottlieb noted.

 

The commissioner stressed the need to evaluate the drug’s potential benefits and harms. He said kratom products must go through the FDA’s drug review process before they can be legally marketed for therapeutic uses in the United States.

 

“This is especially relevant given the public’s perception that it can be a safe alternative to prescription opioids,” he added.

 

So far, no marketer has tried “to properly develop a drug that includes kratom,” Gottlieb said.

 

“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,” Gottlieb added.

 

In 16 countries, kratom is a controlled substance. And in the United States, Alabama, Arkansas, Indiana, Tennessee and Wisconsin have banned kratom. Several other states are reviewing proposals to outlaw it, Gottlieb noted.

 

For now, the FDA said it is working to prevent shipments of kratom from entering the country.

 

“We’ve learned a tragic lesson from the opioid crisis: that we must pay early attention to the potential for new products to cause addiction, and we must take strong, decisive measures to intervene,” Gottlieb said.

 

 

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Rx to Wellness, Uncategorized

Roseroot

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Roseroot — also called Rhodiola — is a plant that has been used in medicine for a variety of conditions.

Roseroot or Arctic root or golden root, is considered an adaptogenic herb, meaning that it acts in non-specific ways to increase resistance to stress, without disturbing normal biological functions. The herb Rhodiola rosea grows at high altitudes in the arctic areas of Europe and Asia, and its root has been used in traditional medicine in Russia and the Scandinavian countries for centuries. Studies of Rhodiola rosea’s medicinal applications have appeared in the scientific literature of Sweden, Norway, France, Germany, the Soviet Union and Iceland. Rhodiola rosea is still widely used in Russia as a tonic and remedy for fatigue, poor attention span, and decreased memory; it is also believed to make workers more productive. In Sweden and other Scandinavian countries, it is used to increase the capacity for mental work and to boost general strength and vitality.

 

As for rhodiola extract benefits, a  review in HerbalGram, the journal of the American Botanical Council, reported that numerous studies of rhodiola in both humans and animals have indicated that it helps prevent fatigue, stress, and the damaging effects of oxygen deprivation. Evidence also suggests that it acts as an antioxidant, enhances immune system function, and can increase sexual energy. Rhodiola’s efficacy was confirmed in a 2011 review of 11 placebo-controlled human studies. The reviewers considered studies that all had study designs rated as moderate to good quality, and the analysis of their combined data concluded that Rhodiola rosea might have beneficial effects on physical performance, mental performance, and certain mental health conditions. The reviewers noted that very few adverse events are reported, suggesting a good safety profile.

 

In addition, a study published in 2007 in the Nordic Journal of Psychiatry, showed that patients with mild-to-moderate depression who took a rhodiola extract reported fewer symptoms of depression than those who took a placebo. A small human trial of rhodiola at UCLA published in 2008, reported significant improvement in 10 people with generalized anxiety who took the herb for 10 weeks. Side effects were generally mild or moderate in severity. The most common unwanted effects were dizziness and dry mouth. Rhodiola appears to work faster than conventional antidepressants, often in less than a week.

A pilot study from the University of Pennsylvania offers support for the possibility that it may improve depression.

Dr. Jun Mao and his colleagues compared roseroot to the antidepressant sertraline and placebo in 57 patients with depression.

After three months, the antidepressant as well as roseroot reduced depression symptoms compared with placebo, but side effects such as sexual dysfunction or nausea were fewer in patients taking the herbal treatment.

You should be able to find roseroot in capsule form.   According to Tieraona Low Dog M.D., says that it is one of her favorite herbs for treatment of patients suffering from “21st century stress”: fatigue, mental fog, trouble concentrating, low energy and, perhaps, mild depression. She recommends using a standardized extract. Look for products that are similar to those studied in clinical trials containing 2-3% rosavin and 0.8-1% salidroside. Start with 100 mg once a day for a week and then increase the dosage by 100 mg every week, up to 400 mg a day, if needed. Dr. Low Dog notes that while studies suggest that rhodiola reduces anxiety, some people might feel “revved” up from it. She advises taking it early in the day to avoid any interference with sleep.

 

 

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