what is the ratio of cesium chloride to dmso for the cancer protocol

FDA alerts health care professionals of significant condom risks associated with cesium chloride

July 23,2018

Summary

Cesium chloride (CsCl) is a mineral salt that is sometimes taken either by oral cavity, or by injection into the body, by cancer patients who seek alternative treatments. Nevertheless, no CsCl products have been approved by FDA to treat cancer or other diseases. Furthermore, beast research has shown that taking CsCl tin can crusade irregular heartbeats, too called arrhythmias. There have been reports of humans experiencing serious middle problems afterwards taking CsCl. CsCl is associated with a lower blood level of potassium, which is a mineral that is essential to normal heart role.^1,iii

FDA received a request that CsCl be moved to the category of majority drug substances (active pharmaceutical ingredients) that present significant condom risks in compounding. FDA intends to take action, such as outcome a warning letter or pursue a seizure of product or injunction, if it encounters compounding using substances placed in this category.^four FDA reviewed all agin events related to CsCl and other cesium salts (herein referred to as "cesium") that were reported to FDA or that were published in medical journals through June 30, 2018. FDA identified 23 reports describing serious adverse events associated with cesium, including issues with the eye.

Adverse Events

FDA identified 5 reports submitted to FDA and 18 published in the medical literature describing patients who experienced adverse events from cesium.^iii,vi-22 Seventeen of those reports were associated with CsCl, compared to half-dozen with other cesium salts like cesium carbonate. Well-nigh patients took cesium to try to treat cancer. The doses described in these cases ranged from 500 milligrams taken every day to 100 grams taken over 11 days. Most reports did not identify where the cesium was obtained. In at least 8 of these cases, health care professionals measured cesium concentrations in the bodies of cesium users and found measured quantities that were several hundred to thousand-fold college than normal.³

Reported adverse events included QT prolongation (a dangerous abnormality that can impair the centre's power to maintain a normal rhythm), low potassium, seizures, potentially lethal arrhythmias, fainting, cardiac arrest (the heart stopped beating), and death. QT prolongation was the about oft reported adverse effect. QT prolongation in the presence of depression potassium ordinarily improves quickly when potassium is administered, but 9 out of 11 of these patients receiving the potassium handling either did non respond besides as expected or did not respond at all. Of the remaining 2 patients, 1 improved as expected and 1 had an unknown response. Iii patients were treated with a cesium-binding agent called Prussian Blue (ferric hexacyanoferrate(II)) and had an comeback in the QT within a few days. For others, it took several weeks after the cesium was stopped for their QT prolongation to improve. This is probably because when cesium is taken on an ongoing footing, information technology leaves the body very gradually and may have from half-dozen months to two years to be eliminated.²⁰

Vi deaths were reported with the utilize of cesium. FDA considers two of these deaths to exist peradventure associated with cesium chloride. The reports for these 2 deaths described cardiac abort or arrhythmia occurring during, or inside 24 hours of injection, of cesium.¹⁹ Three reports did not describe the cause of decease, and ane person may have died from avant-garde cancer and bloodstream infection. However, we cannot exclude cesium as a contributing cistron in these expiry cases. It is often difficult to utilize instance reports to ostend that a drug caused an adverse issue because the reports may exclude important details like cause of death, timing and amount of drug dose, and whether a patient was taking other medicines or had other health problems.

The iii about recent medical literature reports, all published in 2018, depict patients who were taking CsCl to attempt to treat their advanced cancer.^{6, vii, 8} 2 experienced life-threatening arrhythmias and cardiac arrest but were able to be resuscitated. The 3rd had repeated seizures and loss of consciousness. All three patients had very prolonged QT intervals. These cases provide boosted evidence of cesium's power to cause grave harm.

Decision

The use of cesium poses significant safety risks (eastward.g., heart toxicity) and is potentially associated with death. These events can occur with oral assistants and/or injection. This raises serious concerns about its apply in compounding. Therefore, FDA has decided to move CsCl to the category of substances that nowadays significant safety risks in compounding. Consumers, patients, and health care professionals should be aware of the significant potential wellness risks from cesium. FDA encourages consumers, patients, and wellness care professionals to report adverse events or quality problems experienced with the utilise of compounded drug products to FDA's MedWatch Agin Event Reporting program:

• Complete and submit the study online at world wide web.fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at ane-800-FDA-0178.

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References

1. Cesium. Natural Medicines Database website. https://naturalmedicines.therapeuticresearch.com/databases/food,-herbs-supplements/professional.aspx?productid=1064 Updated 11/xxx/2017. Accessed 7/12/2018.
2. Mohsen Nayebpour, B Charles Solymoss, Stanley Nattel. Cardiovascular and metabolic effects of caesium chloride injection in dogs — limitations every bit a model for the long QT syndrome, Cardiovascular Research. 1989;23(9):756–66. https://doi.org/10.1093/cvr/23.9.756
3. Horn S, Naidus E, Alper SL, Danziger J. Cesium-associated hypokalemia successfully treated with amiloride. Clin Kidney J. 2015;8:335–viii doi:x.1093/ckj/sfv017.
4. Acting Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act. January 2017. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469120.pdf Accessed vii/13/2018.
5. Patel, P.R., Rathod, J.. "Life threatening neurologic and cardiac toxicity due to cesium chloride used for the holistic treatment," Am J Respir Crit Care Med, 2018:197:A6906.
6. Rodriguez, F.F., Liroff, G.G., "Cesium chloride: Prolonging QTC intervals, not life expectancy," J of Gen Int Med, 2018:33;490.
7. Mahida H., Maludum O., Ugoeke N., Gharia B., Calderon D., Litsky J., Patel A., "Cesium induced acquired long QT syndrome leading to torsades de pointes", Journal of the American College of Cardiology, 2018:71 (11); A2612.
8. Saliba W, Erdogan O, Niebauer Chiliad. Polymorphic ventricular tachycardia in a woman taking cesium chloride. Pacing Clin Electrophysiol. 2001;24(iv Pt 1):515-7.
9. Pinter A, Dorian P, Newman D. Cesium-induced torsades de pointes. N Engl J Med. 2002;346(5):383-iv.
10. Lyon AW, Mayhew WJ. Cesium toxicity: a example of self-handling by alternate therapy gone awry. Ther Drug Monit. 2003;25(1):114-6.
11. Centeno JA, Pestaner J, Omalu B, Torres Northward, Field F, Wagner G, et al. Blood and tissue concentration of cesium after exposure to cesium chloride: a written report of two cases. Biol Trace Elem Res. 2003;94(2):97-104.
12. Dalal AK, Harding JD, Verdino RJ. Caused long QT syndrome and monomorphic ventricular tachycardia later on alternative treatment with cesium chloride for encephalon cancer. Mayo Clin Proc. 2004;79(8):1065-9. Erratum in: Mayo Clin Proc. 2004;79(nine):1215.
13. Curry TB, Gaver R, White RD. Caused long QT syndrome and elective anesthesia in children. Paediatr Anaesth. 2006;16(4):471-8.
14. Vyas H, Johnson K, Houlihan R, Bauer BA, Ackerman MJ. Caused long QT syndrome secondary to cesium chloride supplement. J Altern Complement Med. 2006;12(x):1011-four.
15. O'Brien CE, Harik N, James LP, Seib PM, Stowe CD. Cesium-induced QT-interval prolongation in an boyish. Pharmacotherapy. 2008;28(8):1059-65. doi: x.1592/phco.28.viii.1059.
16. Chan CK, Chan MH, Tse ML, Chan IH, Cheung RC, Lam CW, Lau FL.Life-threatening Torsades de Pointes resulting from "natural" cancer handling. Clin Toxicol (Phila). 2009; 47(6):592-4.
17. Wiens M, Gordon W, Baulcomb D, Mattman A, Mock T, Brown R. Cesium chloride-induced torsades de pointes. Can J Cardiol. 2009;25(9):e329-31.
18. Sessions D, Heard Thousand, Kosnett M. Fatal cesium chloride toxicity after alternative cancer treatment. J Altern Complement Med. 2013;19(12):973-5.
19. Young F, Bolt J. Torsades de pointes-a report of a case induced by caesium taken as a complementary medicine, and the literature review. J Clin Pharm Ther. 2013; 38:254-seven.
20. Khangure SR, Williams E, Welman C. CT brain findings in a patient with elevated brain cesium levels. Neuroradiol J. 2013;26(vi):607-9. Epub 2013 December 18.
21. Warsame MO, Gamboa D, Nielsen EW. [A adult female in her forties with cancer, syncope and spasms]. Tidsskr Nor Laegeforen. 2014;134(19):1855-7.

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Source: https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-professionals-significant-safety-risks-associated-cesium-chloride

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