Phosphocol P 32 FDA Alerts
The FDA Alert(s) below may be specifically about Phosphocol P 32 or relate to a group or class of drugs which include Phosphocol P 32 (chromic phosphate p32).
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for chromic phosphate p32
Phosphocol P 32 (Chromic Phosphate P 32 Suspension)
Sep 18, 2008
Audience: Oncologists, other healthcare professionals[Posted 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.
[August 29, 2008 - Letter – Covidien]