FDA Bans Cesium Chloride
As Compounded Drug Ingredient

Stephen Barrett, M.D.

In 2018, the U.S. Food and Drug Administration (FDA) banned cesium chloride (CsCl) for use as an ingredient in compounded drugs [1]. Cesium chloride is a mineral salt that some offbeat practitioners prescribe to cancer patients, even though it is not FDA-approved. Theough June 30, 2018, the FDA identified 23 reports of patients who were harmed, including six who died. Eighteeen of these reports had been published in medical journals; the others were reported to the FDA. The most frequently reported harmful effects were disturbance of heart rhythm [2].

The FDA also announced that it would take regulatory action, such as issuing a warning letter, seizure of product, seeking a court injunction, or criminal prosecution, against any pharmacy or health care practitioner compounding a drug containing cesium chloride. Before the announcement, CsCl was on the FDA's list of "Category 1" substances that could be used in compounding without fear of regulatory action until they were definitively reviewed by the FDA. The FDA has now moved CsCl to the "Category 2" list of substances that are banned because of significant safety risks.

Attorney Jann Bellamy believes the FDA should have done this two years ago but instead gave credence to "supporting information" submitted by the American Association of Naturopathic Physicians, the Alliance for Natural Health, the Integrative Medicine Consortium, and McGuff Compounding Pharmacy Services. Bellamy wrote that what happened "should demonstrate to everyone . . . the absolute disregard for evidence of safety and effectiveness on the part of naturopathic 'doctors' and integrative physicians and their 'professional' organizations." [3]  She has also blasted state legislators and medical boards for failing to protect the public from unscientific practitioners [4,5].

The FDA has known about cesium chloride problem for at least 20 years. In 2001, Allen J. Hoffman was sentenced to 46 months in federal prison and one year of supervised probation and ordered to pay $222,506 in restitution. Prosecutors said that Hoffman, through his Baltimore-based T-Up Inc., treated more than 3,000 patients with a mixture of aloe vera and cesium chloride. Press reports indicate that he pleaded guilty in U.S. District Court in Baltimore to two felony counts of introducing an unapproved new drug into interstate commerce with the intent to defraud the FDA [6]..

In 2019, Quackwatch received a report of a woman who nearly died after a month of cesium chloride prescribed by a naturopath. While out with her husband, she had a cardiac arrest and fell to the ground. Luckily, her husband was able to resuscitate her with CPR and she was able to receive further treatment in a hospital.

References

  1. Safety risks associated with certain bulk drug substances nominated for use in compounding. FDA Web site, July 31, 2018.
  2. FDA alerts health care professionals of significant safety risks associated with cesium chloride. FDA news release, July 23, 2018.
  3.  Bellamy J. FDA blacklists cesium chloride, ineffective and dangerous naturopathic treatment. Science-Based Medicine. Aug. 2, 2018.
  4. Bellamy J. Legislative alchemy 2017: Naturopathy. Science-Based Medicine, Dec 21, 2017.
  5. Bellamy J. State medical boards should not recognize board certification in "integrative medicine". Science-Based Medicine.
  6. Willis L. Man gets term of 46 months in aloe vera case: Concoction distributed as a treatment for cancer. Baltimore Sun, Dec 1, 2001.

This article was posted on February 4, 2019.

Links to Recommended Vendors

  • PharmacyChecker.com: Compare drug prices and save money at verified online pharmacies.
  • ConsumerLab.com: Evaluates the quality of dietary supplement and herbal products.
  • Amazon.com: Discount prices, huge inventory, and superb customer service
  • OnlyMyEmail: Award-winning anti-spam services.
  • 10 Types: Website design, development, and hosting with superb technical support.