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U.S. Department of Health and Human Services

Safety

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Phosphocol P 32 (chromic phosphate P 32 suspension) August 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Leukemia

PRECAUTIONS

  • Pediatric Use
    • Risk of Malignancy
      • Acute lymphocytic leukemia has been reported in children following the intra-articular administration of Phosphocol P32 (See WARNINGS).

ADVERSE REACTIONS

  • Postmarketing Experience
    • Leukemia in Children (see WARNINGS)
    • Radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following administration of P 32 into the peritoneal cavity.

WARNINGS

Leukemia

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). Phosphocol P 32 is not indicated in the intra-articular treatment of hemarthroses.