Regulatory Focus™ > News Articles > 7 > In Wake of New Lawsuit, FDA Moves to Address Dangers Linked to Cesium Chloride

In Wake of New Lawsuit, FDA Moves to Address Dangers Linked to Cesium Chloride

Posted 23 July 2018 | By Ana Mulero 

In Wake of New Lawsuit, FDA Moves to Address Dangers Linked to Cesium Chloride

In a move that partly muted a new lawsuit, the US Food and Drug Administration (FDA) issued a set of announcements on Monday aimed at addressing the dangers of using cesium chloride.
 
Public Citizen’s lawsuit against FDA alleges inaction on a 2017 petition calling for the addition of cesium chloride to the list of bulk drug substances that raise significant risks to patient safety.
 
The nonprofit’s request was made after a series of adverse event reports associated with the use of cesium chloride, including cardiac arrest and death. The suit also followed a conclusion reached during a 2016 FDA advisory committee meeting that the mineral salt is unsafe for human use, Michael Carome, director of Public Citizen's Health Research Group, told Focus.
 
FDA’s new three-pronged plan to tackle the risks linked to cesium chloride use includes moving it to category 2 under the agency’s 2017 interim policy on compounding with drug substances, as had been requested by Public Citizen.
 
In response, Carome said Public Citizen is “pleased to see FDA take action” against the compounding of cesium chloride among pharmacists and providers. But the agency could have taken action years ago to protect patient safety, Carome added.
 
“Although we support the FDA’s belated action today to block pharmacy compounding of cesium chloride, the agency should have acted more than two years ago when its own reviewers concluded that cesium chloride is ‘not safe for human use’ and ‘has not been shown to be efficacious for the prevention or treatment of any form of cancer,’” Public Citizen said in a statement.
 
At least 23 instances of cesium chloride-associated adverse events have been reported, six of which reported patient deaths, though the cause of death is inconclusive, according to FDA.
 
“FDA seeks to implement the statutory requirements for bulk drug substances that can be used in compounding in a way that strikes a balance between preserving access to compounded drugs for patients who have a medical need for them while reducing the safety risks and protecting the FDA drug approval process,” FDA Commissioner Scott Gottlieb said.
 
Other components of the new policy framework involve a compounding risk alert to care providers and two research collaborations with the University of Maryland and Johns Hopkins University to support FDA in its developing the list of bulk drug substances for compounding.
 
Public Citizen’s lawsuit is pending in the US District Court for the District of Columbia until permanent action is taken, Carome added.

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe