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Company Issues Warnings After Patients Develop Leukemia

On August 29, 2008, Covidien, a global healthcare company, sent letters to physicians cautioning the “off-label” use, prescribing a drug for indications not approved by the U.S. Food and Drug Administration (FDA), of their injectable drug Phosphocol® P32 (Chromic Phosphate P32 Suspension). The primary component of the therapy is the radioactive isotope P32. The letters, signed by Covidien Chief Medical Officer Herbert Neuman, MD, were sent after two children with hemophilia developed leukemia after receiving intra-articular injections of Phosphocol® P 32.

Manufactured by Covidien’s Mallinckrodt pharmaceutical products line, Phosphocol® P32 is FDA-approved for the treatment of fluid leakage in the lungs or abdominal cavity, typically caused by cancer or infection. In some instances, doctors choose off-label use of Phosphocol® P32 to treat chronic synovitis in hemophilia patients, a condition caused by repeated bleeding into a joint, leading to fluid buildup and inflammation of the joint’s synovial lining. If left untreated, chronic synovitis can cause even more bleeding and the destruction of cartilage, resulting in pain and arthritis.

To reduce the synovial inflammation and prevent further joint damage, some physicians use P32 in a procedure known as radiosynovectomy (RS). While the therapy can be employed as a quick, effective and far less costly alternative to surgery, exposure to radiation carries with it some risk. The two children with hemophilia, ages 9 and 14, developed acute lymphocytic leukemia approximately 10 months after receiving Phosphocol® P32 injections.

“We strongly encourage medical professionals and their patients to follow the guidelines outlined in the prescribing information,” Covidien stated in a written statement. The company has since added warnings to the product’s label.

Covidien, formerly known as Tyco Healthcare, specializes in medical devices, imaging, medical supplies and pharmaceuticals. Its U.S. headquarters are in Mansfield, MA,

Read the National Hemophilia Foundation’s Medical and Scientific Advisory Council’s Recommendations Regarding Radionuclide Synovectomy, MASAC Recommendation #176, which also referenced two cases of leukemia after the procedure.

Source: Reuters, September 18, 2008



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