Other safety alerts
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| The United States: FDA alerts healthcare professionals of significant safety risks associated with cesium chloride |
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The US Food and Drug Administration (FDA) announces that there have been reports of humans experiencing serious heart problems after taking cesium chloride (CsCl). CsCl is associated with a lower blood level of potassium, which is a mineral that is essential to normal heart function. CsCl is a mineral salt that is sometimes taken either by mouth, or by injection into the body, by cancer patients who seek alternative treatments. However, no CsCl products have been approved by FDA to treat cancer or other diseases. Furthermore, animal research has shown that taking CsCl can cause irregular heartbeats, also called arrhythmias.
FDA reviewed all adverse events related to CsCl and other cesium salts (herein referred to as “cesium”) that were reported to FDA or that were published in medical journals through 30 Jun 2018. FDA identified 23 reports describing serious adverse events associated with cesium, including problems with the heart.
FDA identified 5 reports submitted to FDA and 18 published in the medical literature describing patients who experienced adverse events from cesium. Seventeen of those reports were associated with CsCl, compared to 6 with other cesium salts like cesium carbonate. Most patients took cesium to try to treat cancer. The doses described in these cases ranged from 500 milligrams taken every day to 100 grams taken over eleven days. Most reports did not identify where the cesium was obtained. In at least 8 of these cases, healthcare professionals measured cesium concentrations in the bodies of cesium users and found measured quantities that were several hundred to thousand-fold higher than normal.
Reported adverse events included QT prolongation (a dangerous abnormality that can impair the heart’s ability to maintain a normal rhythm), low potassium, seizures, potentially lethal arrhythmias, fainting, cardiac arrest (the heart stopped beating), and death. QT prolongation was the most frequently reported adverse event.
Six deaths were reported with the use of cesium. FDA considers two of these deaths to be possibly associated with cesium chloride. The reports for these two deaths described cardiac arrest or arrhythmia occurring during, or within 24 hours of injection, of cesium. Three reports did not describe the cause of death, and 1 person may have died from advanced cancer and bloodstream infection. However, FDA cannot exclude cesium as a contributing factor in these death cases. It is often difficult to use case reports to confirm that a drug caused an adverse event because the reports may exclude important details like cause of death, timing and amount of drug dose, and whether a patient was taking other medicines or had other health problems.
The three most recent medical literature reports, all published in 2018, describe patients who were taking CsCl to try to treat their advanced cancer. Two experienced life-threatening arrhythmias and cardiac arrest but were able to be resuscitated. The third had repeated seizures and loss of consciousness. All three patients had very prolonged QT intervals. These cases provide additional evidence of cesium’s ability to cause grave harm.
The use of cesium poses significant safety risks (e.g., heart toxicity) and is potentially associated with death. These events can occur with oral administration and/or injection. Consumers, patients, and healthcare professionals should be aware of the significant potential health risks from cesium.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/../ucm614211.htm
In Hong Kong, there is no registered pharmaceutical product containing cesium.
Ends/Tuesday, Jul 24, 2018
Issued at HKT 16:00
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