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U.S. Department of Health and Human Services

About FDA

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FDA approves changes in the Avastin (beacizumab) package insert

Recent changes have been made to the Avastin Injection prescription information.  These changes include:

  • Warnings regarding the occurrence of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) in patients receiving Avastin
  • Recommendation for Avastindiscontinuation in patients who develop RPLS
  • Addition of Nasal Septum Perforation as a Serious Adverse Event in patients receiving Avastin

Full prescribing information, including the above changes, is available in Drugs@FDA

 

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by phone at 1-800-FDA-1088, by facsimile 1-800-FDA-0178, by mail, or by using the Form 3500 

 

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