Association of Phosphocol P32 (Chromic Phosphate P32) with acute lymphocytic leukemia (ALL) - For Health Professionals

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Contact: Marketed Health Products Directorate (MHPD)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Tyco Healthcare.
Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on Phosphocol P32

March 25, 2009

Dear Healthcare Provider:

Subject: Association of Phosphocol ^® P32 (Chromic Phosphate P32) with acute lymphocytic leukemia (ALL)

Mallinckrodt Inc., a Tyco Healthcare /Covidien company, in collaboration with Health Canada, would like to inform you of important new safety information concerning Phosphocol^® P32 (Chromic Phosphate P32 Suspension). Phosphocol^® P32 is authorized for intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease.

As a result, the Canadian Product Monograph (CPM) for Phosphocol^® P32 will be updated to include the following warning:

Leukemia
Phosphocol P32 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 P32 (0.6 and 1.5 mCi total dose). Phosphocol P32 is not indicated in the treatment of hemarthroses.

In addition, the Phosphocol^® P32 CPM 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 Phosphocol P32.

Please refer to the Canadian Product Monograph for the current full prescribing information for Phosphocol^® P32.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious acute lymphocytic leukemia or other serious or unexpected adverse reactions in patients receiving Phosphocol P32 should be reported to Tyco Healthcare or Health Canada at the following addresses:

Sincerely,

original signed by

Joseph Di Marzo
Director, Regulatory Affairs and Quality Assurance

Reference:
1. Dunn AL, Manco-Johnson M, Bush MT, Balark KL, Abshire TC. Leukemia and P32 radionuclide synovectomy for hemophilic arthropathy. Journal of Thrombosis and Haemostasis 2005; 3: 1541-1542.