Covidien and Mallinckrodt have notified healthcare professionals that two children 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).
Phosphocol P 32 is a radiopharmaceutical approved for the intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease. The drug is not indicated in the intra-articular treatment of hemarthroses, according to the Hamilton, Bermuda-based Covidien.
In response, the company has added an additional warning statement in the Phosphocol P 32 package insert regarding the increased risk for leukemia in certain situations.
Additionally, the 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, the company said.
Healthcare professionals should refer to the product's revised prescribing information for updated information regarding the appropriate use of Phosphocol P 32, according to Covidien’s Aug. 29 letter.