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Leukemia Risk Seen with Unapproved Use of Phosphocol P 32

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Unapproved use of the cancer drug Phosphocol P 32 has been tied to two cases of leukemia in children. Phosphocol P 32, made by Covidien Ltd.,  is  approved to treat fluid leaking in the lungs or abdominal cavity caused by spreading diseases such as cancer or infection. Covidien has added information about the leukemia cases to the “Warnings” section of the Phosphocol P 32 label.  In addition, “leukemia in children” is now noted as a risk in the label’s “Adverse Events” section.

In a letter sent to doctors informing them of the labeling changes, Covidien  said that the “Adverse Events” section of the Phosphocol P 32 label has  also been updated to include information about post-marketing reports  that showed patients experienced radiation injury to the small bowel, bladder and part of the large intestine known as the cecum following administration of the drug.

To avoid complications, Covidien said in a statement that it  “strongly encourage medical professionals and their patients to follow the guidelines outlined in the prescribing information” included with Phosphocol P 32.

According to the Food & Drug Administration (FDA), two children ages 9 and 14 with hemophilia who had received intra-articular injection Phosphocol P 32 developed acute lymphocytic leukemia approximately 10 months later.  Phosphocol P 32 is not  not approved to treat that condition.

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