Drugs

FDA Warns Makers of Supplements with Cesium Chloride

FDA has sent Warning Letters to five companies manufacturing dietary supplements containing cesium chloride. An agency statement says that cesium chloride is a new dietary ingredient that has not previously been present in the food supply in a non-chemically altered form. Firms are required to provide specific safety-related information about the ingredient to FDA before including it in a supplement.

The statement cites a 2/2020 public health alert warning consumers and healthcare professionals to avoid using dietary supplements containing cesium salts, primarily cesium chloride. It also says that in 7/2018 FDA alerted healthcare professionals about significant safety risks associated with cesium chloride in compounded drugs.

Although cesium chloride is sometimes promoted as an alternative treatment for cancer, FDA says that no products containing it have been approved by the agency to treat cancer or any other disease.

The Warning Letters went to American Neutraceuticals, Complete H2O Minerals, Daily Manufacturing, Elemental Research and The Mineral Store, and Essence-of-Life. The companies were told to respond within 15 days stating how they will correct the violations. Failing to correct the violations promptly, or to provide reasoning and supporting information as to why the products do not violate the law, could result in legal action including product seizure and/or injunction, FDA says.

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