FDA petitioned to ban API that its reviewers say poses safety risks

The FDA has been petitioned to ban the API cesium chloride.

The public advocacy group Public Citizen has petitioned the FDA to ban an API that it says the FDA has said shouldn’t be used on cancer patients but is still showing up in compounded products.

Public Citizen Wednesday petitioned (PDF) the FDA to ban cesium chloride, pointing to an FDA review in June 2016 that recommended it not be on the approved list. The FDA reviewers said it hadn’t been found effective "for the prevention or treatment of any form of cancer," and that it is “not safe for human use." Most concerning, it can cause fatal abnormal heart rhythms, cardiac arrest and adverse neurological effects.

Among evidence cited by the FDA were animal studies where the ingredient caused tachycardia and toxicity.  

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

“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.”

Among the groups that had asked that the ingredient be available for compounding was the American Association of Naturopathic Physicians. Supporters said that cesium chloride has a history of use among various professions in alternative medicine in the U.S., and that while there were anecdotal evidence about health risks, there were no “peer reviewed articles” showing any dangers.


Suggested Articles

Online pharmacy Valisure has criticized the FDA for what it deems as irrational standards in the levels of suspected carcinogens in the drug supply.

Bluebird Bio says the launch of Zynteglo, its first gene therapy, will not occur until 2020 while it tightens up its manufacturing processes.

Catalent is buying a site in Italy from Bristol-Myers Squibb that handles biologics along with old-school solid dose production.