FDA MedWatch

Phosphocol P 32- Risk Of Leukemia Associated With Off-Label Intra-articular Use In Children

09/18/2008- Covidien and Mallinckrodt Inc. informed healthcare professionals of important new safety information in prescribing Phosphocol P 32. Phosphocol P 32 is approved for the intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease. Phosphocol P 32 may increase the risk for leukemia in certain situations. Two children (ages 9 and 14) with hemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of Phosphocol P 32 (0.6 and 1.5 mCi total dose). This drug is not indicated in the intra-articular treatment of hemarthroses. Additionally, post marketing experience identified radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following administration of P 32 into the peritoneal cavity. Healthcare professionals should refer to the product's revised prescribing information for updated information regarding the appropriate use of Phosphocol P 32.

Read the entire 2008 MedWatch Safety Summaries, including a link to the manufacturer's Dear Healthcare Provider Letter and the revised prescribing information for Phosphocol P 32. 

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Phosphocol