Leukemia Risk with Intra-Articular Use of Phosphocol P 32

Covidien and Mallinckrodt, the manufacturers of Phosphocol P 32, have informed healthcare professionals that this drug may increase the risk of leukemia in certain situations. Phosphocol P 32 is used to treat peritoneal or pleural effusions in patients with metastatic cancer. It is instilled into the peritoneal or pleural cavities, where it locally irradiates tissues.

The manufacturers report that two children, ages 9 and 14, developed acute lymphocytic leukemia about 10 months after they received Phosphocol P 32 by intra-articular injection. Phosphocol P 32 is not indicated for intra-articular injection in treating hemarthroses, and its safety and effectiveness in children have not been established.

Phosphocol P 32 can also cause radiation injury to the small bowel, cecum and bladder when it is instilled into the peritoneal cavity.

FDA Patient Safety News: Dec. 2008

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=82#2

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Education

Tags:

• Leukemia
• cancer
• children
• FDA
• adverse event