News Brief for February 2018

FDA Should Block Use of Cancer Treatment Ingredient Found to Be “Not Safe for Human Use”

On Dec. 6, 2017, Public Citizen’s Health Research Group petitioned the Food and Drug Administration (FDA) to ban a cancer treatment ingredient from use in pharmacy compounding because of serious health risks to humans. FDA staff determined more than 18 months 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, due to FDA policies regarding pharmacy compounding, licensed pharmacists and physicians currently are allowed to compound medications containing cesium chloride. Compounding is the process of combining, mixing or altering ingredients to create a medication tailored to the needs of an individual patient. Compounded medications are not FDA-approved, which means the agency does not verify their safety, effectiveness or quality before they are marketed.

In its petition to the FDA, Public Citizen asked that the agency immediately place cesium chloride on a list of bulk drug substances that present safety risks and should not be compounded. The agency also should issue a rule banning the ingredient’s use long-term. “We are astonished that the FDA has not yet taken action to prevent pharmacy compounding of cesium chloride by placing it on the list of bulk substances identified by the agency as presenting a significant safety risk in compounding,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group. “The failure to take such action represents an unreasonable and dangerous delay regarding an ineffective compounded medication that threatens patient safety.” At press time, the FDA had not yet responded to the petition./p>