Banning pharmacy compounded cesium chloride
The FDA partially granted Public Citizen’s petition to prohibit the use of cesium chloride in pharmacy compounding. The dangerous product has been promoted as an alternative treatment to cancer.
- 23 Reported cases of serious adverse events associated with the use of cesium chloride, including problems with the heart.
- 2 Number of deaths the FDA said may be linked to the use of cesium chloride.
- 760 Number of days it took the FDA to ban cesium chloride after determining it was dangerous.
People expect treatments to be safe and effective. But cesium chloride, peddled as an alternative treatment for cancer, is not.
Cesium chloride is a mineral salt that used to be compounded for cancer patients seeking alternative treatment. Compounding refers to the process of combining, mixing or altering ingredients to create a medication tailored to the needs of an individual patient. Under existing regulation, compounded medications do not have to be approved by the U.S. Food and Drug Administration (FDA). That meant the agency did not have to verify the safety, effectiveness or quality of cesium chloride before it was marketed.
In June 23, 2016, the FDA’s Pharmacy Compounding Advisory Committee met to consider whether various substances should be added to a list of bulk drug substances that could be used to compound drug products. For the purposes of the meeting, the FDA conducted an investigation into cesium chloride. The subsequent report revealed that cesium chloride has not been shown to be effective for “the prevention or treatment of any form of cancer.”
In addition, the agency found that cesium chloride presented “serious safety concerns” because it can cause fatal abnormal heart rhythms, cardiac arrest and adverse neurological effects. As a result, the FDA concluded that cesium chloride should not be used to compound drugs. However, it did not take further action to prevent the use of cesium chloride in compounding.
Public Citizen filed a petition on Dec. 6, 2017, demanding that the FDA ban the use of cesium chloride in pharmacy compounding. In June 4, 2018, the FDA responded to the petition, saying that it had not reached a decision.
In response, Public Citizen filed a lawsuit against the FDA, stating that the agency was endangering the public by not banning the compounding of cesium chloride. The agency responded hours later, partially granting the originally petition by prohibiting the use of cesium chloride in pharmacy compounding. However, it did not grant Public Citizen’s additional request for the agency to make the ban permanent through regulation. It did, however, indicate that it may eventually pursue such a regulation.
In November 2018, Public Citizen exposed Utopia Wellness for promoting on its website the use of intravenous cesium chloride as an alternative treatment for cancer. The website included 30 falsified scientific journal article citations in which citations of actual scientific journal articles related to medial uses of ozone were modified by replacing the term “Ozone” with “Cesium Chloride” in the title. Public Citizen sent complaint letters to the Federal Trade Commission (FTC), Food and Drug Administration (FDA), Florida Board of Medicine and the Florida Attorney General. The agencies responded that they would look into the issue, and information related to cesium chloride has been taken down from the Utopia Wellness website.
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.Dr. Sidney Wolfe, founder and senior adviser, Public Citizen’s Health Research Group