(RxWiki News) The US Food and Drug Administration (FDA) has sent five companies warning letters for marketing products with cesium chloride.
Cesium chloride, a dietary ingredient, may be found in some dietary supplements. It has been promoted as an alternative treatment for cancer. But the FDA stated that it had not approved any products containing cesium chloride to treat any health conditions, including cancer.
The FDA said it is concerned about the risks associated with these products.
According to Steven Tave, director of the FDA's Office of Dietary Supplement Programs, dietary supplements that contain cesium chloride may lead to heart toxicity and potentially even result in death.
In February of this year, the FDA warned both consumers and health care professionals about the use of products containing cesium salts — primarily cesium chloride.
During the summer, the FDA detailed the significant safety risks linked with cesium chloride in compounded drugs.
The FDA stated that there have been multiple clinical case reports and non-clinical studies that have shown safety issues. These safety concerns included deadly cardiac arrhythmias, low potassium, seizures, fainting/unresponsiveness and even death.
The agency said that although it appears that only a few products containing cesium salts are on the market, it still wants consumers to be aware of these products and their risks.
The FDA sent the following five companies warning letters for marketing cesium chloride-containing products:
- American Nutriceuticals, LLC
- Complete H2O Minerals, Inc.
- Daily Manufacturing, Inc.
- Elemental Research, Inc. and The Mineral Store, Inc.
- Essence-of-Life, LLC
The agency was giving these companies 15 working days to submit their plans for how they will correct the violations.
The FDA recommended that consumers immediately stop using these products and contact their health care providers if they believe the products may have caused a reaction or illness. The FDA also recommended that consumers report adverse events to the FDA's MedWatch program.
Speak with your health care provider if you have any questions.