February 5, 2020
- Consumers using dietary supplements containing cesium salts, primarily cesium chloride.
- Health care professionals.
The FDA is warning consumers to avoid using dietary supplements containing cesium chloride or any other cesium salt (collectively referred to as “dietary supplements containing cesium salts”) due to significant safety risks, including heart toxicity and potential death. The FDA is also alerting health care professionals of the risks associated with dietary supplements containing cesium salts.
Summary of Problem and Scope
The FDA is warning consumers and health care professionals to avoid using or recommending 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.
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.
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.
The 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. Our 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 health care professionals that cesium salts presented a significant safety risk in compounding drugs.
Recommendations for Consumers
Although the FDA recommends that consumers do not purchase or use dietary supplements containing cesium salts, if you (or someone in your care) experience an adverse event while using a dietary supplement containing cesium salts, stop consuming the product, seek immediate medical care or advice, and report the adverse event to the FDA through the Safety Reporting Portal. Consumers can also call an FDA Consumer Complaint Coordinator to speak directly to a person about a complaint or adverse event.
The FDA advises consumers to talk to their health care professional before deciding to purchase or use a dietary supplement. Also, if claims sound too good to be true, they probably are. If a consumer thinks that a dietary supplement might have caused a reaction or illness, they should immediately stop using the product, contact their health care professional, and submit a complaint to the FDA using the Safety Reporting Portal.
Recommendations for Health Care Professionals
The FDA advises that health care professionals do not recommend dietary supplements containing cesium salts to their patients. If any patients experience an adverse event while taking a dietary supplement containing cesium salts, the health care professional should report the adverse event to the FDA through the Safety Reporting Portal.
Visit www.fda.gov/fcic for additional consumer and health care professional assistance.