Phosphocol P 32, a drug used in cancer treatment, has been linked to leukemia when used in unapproved ways, the Food & Drug Administration (FDA) announced yesterday. The agency said that the labeling of Phosphocol P 32 was being modified to reflect the risk.
Phosphocol P 32 is approved to treat fluid leaking in the lungs or abdominal cavity caused by spreading diseases such as cancer or infection. According to the FDA, two children ages 9 and 14 with hemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of Phosphocol P 32. The drug had been administered to the children to treat bleeding between the joints caused by hemophilia. The drug is not approved to treat that condition.
The drug’ maker, Covidien Ltd, 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.
Acute lymphocytic leukemia is the most common type of cancer in children. It affects the blood and bone marrow — the tissue inside bones where blood cells are made. The disease progresses rapidly and affects immature blood cells, rather than mature ones. This type of leukemia affects the white blood cells called lymphocyte. Acute lymphocytic leukemia is also known as acute lymphoblastic leukemia and acute childhood leukemia.
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 to the FDA 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.