Several Die in Arsenic Trioxide Trials
July 2, 2001
Arsenic trioxide, a drug created to treat leukemia patients, has come under scrutiny by the FDA after two separate clinical trials resulted in drug-related deaths. Cell Therapeutics of Seattle, the maker of the arsenic trioxide drug Trisenox, is evaluating the results of these two trials.
The medical journal Blood reports that two of 19 patients at Our Lady of Mercy Cancer Center in New York died from heart arrhythmia associated with arsenic poisoning after being treated with arsenic trioxide. A third patient died of other causes, after developing the heart arrhythmia and recovering from that condition.
The medical journal Blood also published an article from a doctor at St. Louis' Washington University who reported that three of ten patients died of heart-related illnesses after being treated with arsenic trioxide.
Both trials used the same compound that Cell Therapeutics uses for Trisenox; however, Dr. James Bianco, company president, stated that neither trial used brand name products produced by Cell Thearapeutics. Cell Therapeutics has sent a letter to physicians asking them to report any adverse reactions to the drug.
The FDA approved Trisenox last fall as an "orphan drug." "Orphan drugs" are approved to treat conditions that affect less than 20,000 patients. Trisenox was approved to treat acute promyelocytic leukemia, a condition which strikes less than 400 patients each year.
Pharmacists at Our Lady of Mercy Cancer Center had been given permission from the FDA to make their own version of arsenic trioxide. Over the past few weeks, the FDA has collected samples of arsenic trioxide to see if different formulations exist.
-- Article Courtesy of InjuryBoard.com
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