Archived - Association of Phosphocol P32 (Chromic Phosphate P32) with acute lymphocytic leukemia (ALL) - For the Public

Starting date:

March 25, 2009

Posting date:

March 30, 2013

Type of communication:

Public Communication

Subcategory:

Drugs, Affects children, pregnant or breast feeding women

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000771

This is duplicated text of a letter from Tyco Healthcare.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication

Health Canada Endorsed Important Safety Information on Phosphocol P32

March 25, 2009

Subject: Reports of acute lymphocytic leukemia associated with Phosphoco P32 (Chromic Phosphate P32)

Mallinckrodt Inc., a Tyco Healthcare /Covidien company, in consultation with Health Canada, has informed Canadian healthcare professionals of important new safety information about Phosphocol™ P32 (chromic phosphate P32 suspension).

Phosphocol P32 is authorized for the treatment of cancer that has spread into either the abdominal or chest cavity.

• Two children with hemophilia (a bleeding disorder) developed a type of cancer called acute lymphocytic leukemia ("ALL"). The cancer developed within one year of Phosphocol P32 being injected into certain joints that were bleeding.
• Phosphocol P32 is not authorized for injection into joints.
• Contact your doctor if you develop any unusual symptoms following the injection of Phosphocol P32.

Tyco Healthcare is aware of the risk of acute lymphocytic leukemia ("ALL") to patients if Phosphocol P32 is injected into joints and will be updating the prescribing information with the new information on ALL as well as other side effects that have been reported.

Additional safety information

There have been reports of radiation burns and development of scarring in the small bowel, the initial portion of the large bowel (caecum) and bladder following administration of Phosphocol P32 into the abdominal cavity.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Any case of 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:

Tyco Healthcare (Covidien)

7300 Trans-Canada

Pointe-Claire, Quebec

H9R 1C7

1-877-664-8926

514-695-1220

Any suspected adverse reaction can also be reported to:

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: 866-234-2345Fax: 866-678-6789

CanadaVigilance@hc-sc.gc.ca

The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.



For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)

E-mail: MHPD_DPSC@hc-sc.gc.ca

Tel: 613-954-6522

Fax: 613-952-7738

Sincerely,

original signed by

Joseph Di Marzo

Director, Regulatory Affairs and Quality Assurance

References:

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.