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Chromic Phosphate P32 Associated With ALL, Warns Health Canada Ottawa, Ontario -- April 1, 2009 -- Mallinckrodt Inc./Tyco Healthcare, in collaboration with Health Canada, are informing healthcare professionals regarding important new safety information concerning chromic phosphate P32 suspension (Phosphocol P32). Two children with haemophilia developed acute lymphocytic leukaemia within 1 year after intra-articular injections of chromic phosphate P32. Chromic phosphate P32 is not authorised for intra-articular injection. Physicians should be vigilant for signs and symptoms of leukaemia in patients who have received chromic phosphate P32. As a result, the Canadian Product Monograph (CPM) for chromic phosphate P32 will be updated to include the following warning: Leukaemia [Chromic phosphate P32] may increase the risk for leukaemia in certain situations. Two children (ages 9 and 14) with haemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of [chromic phosphate P32] (0.6 and 1.5 mCi total dose). [Chromic phosphate P32] is not indicated in the treatment of hemarthroses. In addition, the PM will be updated to include post-marketing reports of radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following peritoneal administration of chromic phosphate P32. Any case of serious acute lymphocytic leukaemia or other serious or unexpected adverse reactions in patients receiving chromic phosphate P32 should be reported to Tyco Healthcare or Health Canada at the following addresses: Tyco Healthcare (Covidien) 7300 Trans-Canada Pointe-Claire, Quebec H9R 1C7 1-877-664-8926 Canada Vigilance Program Marketed Health Products Directorate HEALTH CANADA Address Locator: 0701C Ottawa, Ontario, K1A 0K9 Telephone: 613-957-0337 or Fax: 613-957-0335 To report an Adverse Reaction, consumers and health professionals may call toll free: Telephone: 866-234-2345 Fax: 866-678-6789 CanadaVigilance@hc-sc.gc.ca SOURCE: Health Canada E-mail this page to a friend or colleague! To print, use this version