Market Updates, Regulations

FDA Issues Health Alert for Dietary Supplements Containing Cesium Salts

Review identified multiple clinical case reports and non-clinical studies that suggest cesium chloride and other cesium salts pose significant safety risks.

The FDA issued a warning to consumers to avoid using dietary supplements containing cesium chloride or any other cesium salt due to what it called significant safety risks, including heart toxicity and potential death. The FDA also alerted healthcare professionals of the risks associated with dietary supplements containing cesium salts.
 
Multiple clinical case reports and non-clinical studies show significant safety concerns related to the use of such products, including potentially fatal cardiac arrhythmias, hypokalemia (low potassium), seizures, syncope (fainting, unresponsiveness), and death, FDA said in its warning.
 
Cesium salts, such as cesium chloride, are sometimes promoted as alternative treatments for cancer. Cesium salts have never been proven to be safe and effective to treat cancer or for any other use, FDA said.
 
While it appears that few dietary supplements containing cesium salts are currently on the market, consumers should be aware of the risks associated with them and should avoid purchasing and using such products.
 
FDA conducted a comprehensive review of the CFSAN Adverse Event Reporting System (CAERS) database related to cesium salts and reviewed other available information, including published studies and case reports, to evaluate the safety of dietary supplements containing cesium salts in response to a Citizen Petition filed by Public Citizen and Public Citizen’s Health Research Group. The review identified multiple clinical case reports and non-clinical studies that suggest that cesium chloride and other cesium salts pose significant safety risks.
 
In addition, in July 2018, the FDA warned healthcare professionals that cesium salts presented a significant safety risk in compounding drugs.
 

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