Ketamine Widely Dispensed Despite FDA Warning: Not Approved for Psychiatric Use

CCHR reports the hallucinogen can lead to addiction, health problems and death, yet unregulated ketamine clinics are a $3.1 billion industry in the U.S.

Los Angeles, United States - October 30, 2023 /PressCable/ —

The Food and Drug Administration (FDA) recently issued a warning stating that ketamine, an anesthetic with hallucinogenic properties, lacks approval for the treatment of any psychiatric disorder. Despite this, compounded ketamine products (those having combined, mixed, or altered ingredients to make a medication) have been widely marketed for such conditions, a practice known as “off-label.” The FDA has not verified the safety or efficacy of ketamine for such uses, raising concerns about abuse, misuse, psychiatric side effects, increased blood pressure, and respiratory depression.[1] Citizens Commission on Human Rights (CCHR) International, a 54-year mental health industry watchdog that has documented a history of promised “miracle-turned-unworkable” drugs in the mental health system, says damaging hallucinogens are but another vector in a mind-altering culture that psychiatrists have steered society into using biomedical “solutions” for problems.

Known safety concerns for ketamine also include psychiatric events, increases in blood pressure, and respiratory depression.[2] The New York Times reported ketamine “can be addictive, and heavy, long-term use can lead to significant health problems.”[3] Overdose, resulting in death, is also a risk.[4]

CCHR warns that ketamine should never be approved for any so-called psychiatric disorder, noting the practice is already out of control. There are hundreds of unregulated ketamine infusion clinics in the U.S., essentially where mainlining hallucinogenic drugs is done without any oversight, it says.

Ketamine infusion clinics have fought for a slice of the estimated $3.1 billion market.[5]

An international law firm has pointed out that, concerning the control and supervision of ketamine clinics, there is no regulation by the FDA. In this context, it appears to be a matter of “dealer's choice” in determining how such businesses are conducted, which extends to establishing patient safety protocols.[6]

The drug is injected for psychiatric conditions and pain management, with centers charging anywhere from $300 up to $2,000 a treatment.[7] ABC News reported one large chain of ketamine clinics offers 13-session programs ranging in cost from $5,250 to $6,750.[8]

For several years, CCHR has exposed the dangers of ketamine and these clinics, especially as it is also abused and known as a “date rape drug” because it causes disassociation in victims unwittingly drugged with it before being sexually assaulted.[9]

A study published in March 2023 in the American Journal of Drug Alcohol Abuse, said “the use of ketamine and/or its analogues [similarly structured products], as well as combinations with other drugs, can be fatal.” Researchers found 18 articles that described fatal cases and 16 overdoses. Poly-substance use was mentioned in 53% of the selected articles. A total of 312 overdose cases and 138 deaths were reported. In both death reports and overdose cases, ketamine was preponderant: 89.1% and 79%, respectively.[10]

As an example, a patient receiving treatment at a Baton Rouge psychiatric hospital was found unresponsive in her room and later died from the effects of ketamine. Officials don't know how she obtained and ingested the drug that killed her. The ketamine caused her brain to become deprived of oxygen, which in turn caused her death, the East Baton Rouge Coroner's Office determined.[11]

An investigation published by the medical news website STAT found wide-ranging inconsistencies among ketamine clinics, from the screening of patients to the dose and frequency of infusions. STAT interviewed ketamine clinic owners, psychiatrists, and patients and reviewed online staff pages and screening protocols for dozens of ketamine clinics to gauge how patients are selected and treated. Among the findings: Clinics sometimes overhype the efficacy of ketamine, offer it for uses that haven’t been well-studied, and tout special blends that experts say aren’t supported by published evidence.[12]

One of the largest ketamine clinic chains in the U.S. operating 13 sites out of nine states, abruptly closed in March 2023.[13]

Ketamine is also obtained through telemedicine where it is dished out like “candy,” The Guardian reported in April this year.[14] One telemedicine provider offers 30 daily doses for $129 a month. “In a choice between expensive in-person ketamine assisted therapy, and cheap ketamine candy sent straight to your home, many unsurprisingly chose the latter,” The Guardian reported.[15]

CCHR believes ketamine and the push for psychedelics is further evidence of the ongoing failure of the “biomedical” model that places a heavy emphasis on the pharmacological treatment of mental problems, despite international calls for its discontinuation. The October 2023 World Health Organization and the United Nations Office of the High Commissioner for Human Rights guidance on Mental Health, Human Rights, and Legislation, says the model “works to the detriment of other holistic and person-centered and rights-based approaches and strategies.” Further, “Legislation on mental health must therefore take a new direction away from the narrow traditional ‘biomedical paradigm’ that has contributed to coercive and confined environments in mental health services.”[16]

CCHR reiterates that the FDA should never approve ketamine and other hallucinogens for psychiatry’s use on patients, and legislators should prohibit clinics from establishing themselves in their respective states, essentially acting as legalized drug pushers. The Drug Enforcement Administration should also clamp down on internet sales of the drug, and insurance companies should not reimburse any off-label use.

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[1] “FDA warns patients and health care providers about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders,” FDA, 10 Oct. 2023, www.fda.gov/drugs/human-drug-compounding/fda-warns-patients-and-health-care-providers-about-potential-risks-associated-compounded-ketamine; www.nbcnews.com/health/mental-health/ketamine-clinics-mental-health-are-popping-us-treatment-work-rcna63522

[2] Ibid., “FDA warns patients and health care providers…”

[3] www.nytimes.com/2023/10/11/health/fda-ketamine-warning.html

[4] pubmed.ncbi.nlm.nih.gov/36410032/

[5] www.grandviewresearch.com/industry-analysis/us-ketamine-clinics-market-report

[6] www.cchrint.org/2022/04/07/psychiatrys-future-legalized-psychedelic-drug-mainlining-clinics/ citing harrisbricken.com/cannalawblog/the-ketamine-clinic-craze-legalities-and-possibilities/

[7] www.theguardian.com/society/2023/apr/11/ketamine-clinics-us-business-safety-mental-health

[8] abcnews.go.com/Health/closures-ketamine-clinics-leave-patients-scrambling-treatment/story?id=99800266

[9] www.cchrint.org/2019/06/26/cchr-warns-about-antidepressant-nasal-spray-esketamine-spravato-use-on-veterans/

[10] pubmed.ncbi.nlm.nih.gov/36410032/

[11] www.theadvocate.com/baton_rouge/news/crime_police/after-drug-induced-death-at-baton-rouge-psychiatric-hospital-womans-family-seeks-answers/article_2d4ace34-ca98-11e9-861f-d7cf1bfe860d.html

[12] www.statnews.com/2018/09/24/ketamine-clinics-severe-depression-treatment/

[13] www.theguardian.com/society/2023/apr/11/ketamine-clinics-us-business-safety-mental-health

[14] www.cchrint.org/2022/04/07/psychiatrys-future-legalized-psychedelic-drug-mainlining-clinics/; www.theguardian.com/society/2023/apr/11/ketamine-clinics-us-business-safety-mental-health

[15] www.theguardian.com/society/2023/apr/11/ketamine-clinics-us-business-safety-mental-health

[16] www.cchrint.org/2023/09/18/who-guideline-condemns-coercive-psychiatric-practices/ citing World Health Organization, OHCHR, “Guidance on Mental Health, Human Rights and Legislation,” 9 Oct. 2023, pp. xvi and 9

Contact Info:
Name: Amber Rauscher
Email: Send Email
Organization: Citizens Commission on Human Rights International
Address: 6616 Sunset Boulevard, Los Angeles, California 90028, United States
Phone: +1-323-467-4242
Website: https://www.cchrint.org

Source: PressCable

Release ID: 89111646

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