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Author Topic: Children injured by cupping treatment, FDA warnings issued to kratom marketers  (Read 354 times)

Krik

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Consumer Health Digest #19-29
July 21, 2019

Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H
http://www.calstatela.edu/faculty/william-m-london
., with help from Stephen Barrett, M.D
http://www.quackwatch.org/10Bio/bio.html

It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making. Its primary focus is on health, but occasionally it includes non-health scams and practical tips.

###

Children injured by cupping treatment

The South China Morning Post has reported that 92 of 881 children who underwent a form of cupping
https://sciencebasedmedicine.org/cupping-olympic-pseudoscience/
treatment known as sanfutie over a two-day period at Jiangsu Province Children's Hospital in eastern China developed painful blisters and itchy, peeling skin with weeping pus.

The treatment involves applying a herbal paste to the skin, which is then covered by glass cups that are heated to create suction.

Sanfutie is traditionally applied during the hottest periods of the year and is promoted to treat a variety of illnesses and to improve circulation.

The hospital has stopped using it and says it will provide follow-up care of the children.

Parents of many of the affected patients said that they had responded to an online advertisement by the hospital that offered the 400 yuan (US$58) treatment as a remedy for respiratory diseases, digestive illnesses, and weak immune systems in children.

[Chen L. Traditional Chinese medicine treatment blisters children
https://www.scmp.com/news/china/society/article/3018988/traditional-chinese-medicine-treatment-blisters-children
. South China Morning Post, July 17, 2019]

###

Warnings issued to kratom marketers

The U.S. Food and Drug Administration (FDA) has issued warning letters ordering

Cali Botanicals
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cali-botanicals-llc-575320-06112019
of Folsom, California

and

Kratom NC
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kratomnc-576964-05162019
 of Wilmington, North Carolina

to stop selling unapproved, misbranded kratom-containing products.

Similar to previous warnings to kratom marketers
https://www.fda.gov/news-events/press-announcements/fda-warns-companies-selling-illegal-unapproved-kratom-products-marketed-opioid-cessation-pain
, the most recent letters highlight unproven claims that the products can treat or cure opioid addiction and withdrawal symptoms.

The letters also cite unproven claims about treating pain, as well as other medical conditions such as depression, anxiety, and cancer.

Kratom is derived from Mitragyna speciosa
https://www.fda.gov/news-events/public-health-focus/fda-and-kratom
, a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua, New Guinea.

Kratom is not legally marketable in the United States as a drug or dietary supplement.

Substances in kratom appear to have opioid properties.

FDA has warned consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine.

[FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses
https://www.fda.gov/news-events/press-announcements/fda-issues-warnings-companies-selling-illegal-unapproved-kratom-drug-products-marketed-opioid
 

FDA news release, June 25, 2019] The danger was illustrated by three reports:

A CDC study of the State Unintentional Drug Overdose Reporting System found that out of 27,333 people who died of drug overdoses during July 2016 to December 2017, 151 (0.56%) were  exposed to kratom and a medical examiner or coroner determined that kratom was a cause of death for 91 of them.
[O'Malley E. and others. Unintentional drug overdose deaths with Kratom detected—27 states, July 2016-December 2017
https://www.cdc.gov/mmwr/volumes/68/wr/pdfs/mm6814a2-H.pdf
. MMWR. 68(14):326-327, 2019]

Data in the National Poison Data System (NPDS) between January 1, 2011 and July 31, 2018 identified 2,312 reports of kratom exposures with a large increase in reports starting in 2016. For the 935 cases in which kratom was the only drug exposure found, the most common adverse effects were agitation, rapid heart rate, drowsiness, vomiting, and confusion. Severe adverse effects included seizure (in 6.1% of reports), withdrawal sickness (6.1%), hallucinations (4.8%), respiratory depression (2.8%), coma (2.3%), and cardiac or respiratory arrest (0.6%). Four deaths were reported with kratom listed as a cause or contributing factor by the county medical examiner's office during the time period.

[Eggleston W. and others. Kratom use and toxicities in the United States
https://accpjournals.onlinelibrary.wiley.com/doi/abs/10.1002/phar.2280
. Pharmacotherapy 39:775-777, 2019]

An NPDS review of reports from 2011 to 2017 identified 11 deaths involving kratom exposure, including two that occurred with kratom as the only drug exposure.
[Post S. and others. Kratom exposures reported to United States poison control centers: 2011-2017
https://www.tandfonline.com/doi/full/10.1080/15563650.2019.1569236
. Journal of Clinical Toxicology, DOI: 10.1080/15563650.2019.1569236, 2019]

###

"Thought leader in the natural health and wellness fields” profiled

Science communicator Jonathan Jarry of McGill University's Office for Science and Society has profiled Sayer Ji whose main Web site, GreenMedInfo, claims to have more than a million views each month and whose Facebook page has half a million followers. GreenMedInfo features a search engine for studies on a variety of health topics, but Jarry notes that:

* The search engine "cherry picks" studies to make "alternative medicine" treatments look worthwhile.

* Ji offers misleading criticisms of modern biotechnology, community water fluoridation, and vaccines.

* Ji offers misleading health freedom arguments
https://www.youtube.com/watch?v=GRBJEd2anuk
to justify the promotion of dubious healing methods.

[Jarry J. Popular health guru Sayer Ji curates the scientific literature with his bachelor's degree in philosophy
https://mcgill.ca/oss/article/pseudoscience/popular-health-guru-sayer-ji-curates-scientific-literature-his-bachelors-degree-philosophy
. Office for Science and Society, July 11, 2019]

=================================

Stephen Barrett, M.D.
Consumer Advocate
287 Fearrington Post
Pittsboro, NC 27312

Telephone: (919) 533-6009

http://www.quackwatch.org (health fraud and quackery)
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