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On July 23, 2018, the Food and Drug Administration (FDA) partially granted[1] Public Citizen’s December 2017 petition[2] calling on the agency to immediately prohibit the use of heart-toxic cesium chloride — which has been promoted as an alternative treatment for cancer — in pharmacy compounding. The FDA responded to Public Citizen’s petition just hours after the organization sued the agency for not responding to the petition.
FDA staff determined more than two years ago that cesium...
On July 23, 2018, the Food and Drug Administration (FDA) partially granted[1] Public Citizen’s December 2017 petition[2] calling on the agency to immediately prohibit the use of heart-toxic cesium chloride — which has been promoted as an alternative treatment for cancer — in pharmacy compounding. The FDA responded to Public Citizen’s petition just hours after the organization sued the agency for not responding to the petition.
FDA staff determined more than two years ago that cesium chloride has not been shown to be effective for “the prevention or treatment of any form of cancer,” presented “serious safety concerns” and is “not safe for human use.” Most concerning, it can cause fatal abnormal heart rhythms, cardiac arrest and adverse neurological effects.
Despite these findings, prior to the FDA’s action on Public Citizen’s petition, licensed pharmacists and physicians were allowed to compound medications containing cesium chloride due to FDA policies regarding pharmacy compounding. In its petition to the FDA, Public Citizen asked that the agency immediately place cesium chloride on a list of active ingredients that present safety risks and should not be compounded and issue a rule permanently banning use of the ingredient. The FDA took the former action in July and may issue the requested rule in the future.
References
[1] Food and Drug Administration. Partial approval and partial denial of petition for FDA-2017-P-6758. July 23, 2018. https://www.regulations.gov/document?D=FDA-2017-P-6758-0004. Accessed September 13, 2018.
[2] Public Citizen. Petition to the Food and Drug Administration to take action to prohibit use of cesium chloride in pharmacy compounding. December 6, 2017. https://www.citizen.org/sites/default/files/2393.pdf. Accessed September 13, 2018.
