July 23, 2018

FDA Agrees With Public Citizen, Responds to Petition by Taking Action to Prohibit Pharmacy Compounding of Cesium Chloride

Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group

Note: Today, the U.S. Food and Drug Administration (FDA) partially granted Public Citizen’s December 2017 petition (PDF) calling on the agency to prohibit the use of heart-toxic cesium chloride - which has been promoted as an alternative treatment to cancer - in pharmacy compounding. However, the agency denied Public Citizen’s additional request - also contained in the petition - for the agency to make the ban permanent through regulation but indicated it may eventually pursue such a regulation. The agency responded to Public Citizen’s petition just hours after the organization sued (PDF) the FDA for not responding to the petition.

Although we support the FDA’s belated action today to block pharmacy compounding of cesium chloride, the agency should have acted more than two years ago when its own reviewers concluded that cesium chloride is “not safe for human use” and “has not been shown to be efficacious for the prevention or treatment of any form of cancer.” By not acting more expeditiously, the agency has allowed consumers to continue to be exposed to a dangerous and ineffective medication that has been promoted without basis to vulnerable cancer patients.

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