FDA Moves Against Toxic Drug

By Walter F. Roche Jr.

Citing "significant safety risks," the U.S. Food and Drug Administration today took a first step to bar the use of a toxic chemical currently being used by drug compounders for treatment of cancer patients.
FDA Commissioner Scott Gottlieb said the agency was immediately issuing an alert warning to drug compounders about the serious health risks posed by the use of cesium chloride.
In addition Gottlieb announced that the agency will be placing the chemical on a list of substances that are not authorized for use in drug compounding.
In announcing the action, the FDA also stated that if it determines that a compounder is using cesium chloride "it intends to take regulatory, such as issuing a warning letter or seizing product."
The action comes more than six months after Public Citizen, an advocacy group, filed a formal petition with the FDA seeking immediate action to bar use of the chemical. The petition cited findings by the FDA itself about the health risks associated with the drug.
Gottlieb's action comes under the provisions of a new law, the Drug Quality and Security Act, passed in the wake of the deadly 2012 fungal meningitis outbreak which took the lives of 76 patients. Federal prosecutors have stated that the outbreak, caused by fungus laden compounded drugs, was the worst outbreak in history to be caused by a prescription drug.
In announcing today's action the FDA cited adverse effects from cesium, including abnormal heart rhythms, low potassium, seizures, fainting, cardiac arrest and death.
Public Citizen also had requested that the FDA issue a regulation specifically barring the use of cesium chloride, but Gottlieb said the agency would have to give public notice and go through a formal rule making process before it could issue such a regulation.
The December Public Citizen petition signed by Dr. Sidney M. Wolfe noted that "FDA staff determined more than 18 months ago that cesium chloride presents serious safety concerns and is not safe for human use."
Wolfe noted in his letter that oral cesium chloride is advertised by a number of compounding pharmacies. He also cited testimony before an FDA committee that "very vulnerable" patients who turn to the drug are often facing "end-of-life scenarios"
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