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U.S. Department of Health and Human Services

Safety

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Doxil (Doxorubicin HCL) Liposome Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2013

Summary View

 

WARNINGS AND PRECAUTIONS

  • Secondary Oral Neoplasm - Secondary oral cancers, primarily squamous cell carcinoma, have been reported from postmarketing experience in patients with long-term (more than one year) exposure to Doxil…
 

ADVERSE REACTIONS

Post Marketing Experience
  • Secondary oral neoplasms