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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