Drugs

FDA Acts on Cesium Chloride Same Day Lawsuit Filed

On the same day Public Citizen filed a lawsuit against it, FDA 7/23 partially granted the activist group’s objective: a ban on cesium chloride use in drug compounding sought in a 12/2017 petition. The group’s lawsuit was in response to the agency’s inaction on the petition, which asked the agency to move cesium chloride off its permissive list and to issue a rule that prohibits pharmacy compounding of the chemical in drug-containing medications. It says there is a growing body of evidence showing that cesium chloride and other cesium salts cause serious, life-threatening cardiovascular events. The agency action also denied Public Citizen’s additional request for the agency to make the ban permanent through regulation, but it indicated a regulation for such may be considered in the future.

“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 says. “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.”

Additionally, Public Citizen 7/23 petitioned FDA to ban dietary supplements that contain cesium chloride and provide safety communications to consumers and doctors about the dangers of such supplements.

Meanwhile, FDA announced two new research collaborations to support its goal of developing a list of bulk drug substances that can be compounded. The agency says it is collaborating with the University of Maryland and Johns Hopkins University “to gather and analyze information important for developing the list of bulk drug substances that may be used in compounding. The University of Maryland will be working closely with medical specialty groups and researching information about the use of drug products including certain bulk drug substances historically and in current clinical practice. The Johns Hopkins University will systematically study available safety and effectiveness information on certain bulk drug substances for use in compounding drug products for patients with autism spectrum disorder.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome