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    Medication Adverse Event Alert September 29, 2006 MEDICATION: bevacizumab (Avastin)
Event Description: The FDA has announced that in post marketing surveillance, the use of bevacizumab has resulted in several cases of reversible posterior leukoencephalophathy syndrome (RPLS) and nasal septal perforation. Genetech has sent "Dear Healthcare Provider" letters and changed the prescribing information on becavizumab to reflect these occurrences. Description of Adverse Events: RPLS is a rare neurological disorder characterized by a brain-capillary leak syndrome associated with hypertension, fluid retention, and cytotoxic effects of immunosuppresive drugs on the vascular endothelium. Symptoms include headache, seizure, lethargy, confusion, blindness and other neurological disturbances and has been reported to appear 16 hours to 1 year after receiving bevacizumab. Genetech "Dear Healthcare Provider" letter noted there were 7 cases of nasal septal deviation reported with bevacizumab use but did not further elaborate into the events. Recommendations: The manufacturer recommends that if RPLS develops, discontinue bevacizumab and begin treatment for hypertension, if present. Genetech did not provide any recommendations as to whether bevacizumab may be restarted if RPLS resolves. No treatment recommendations for nasal septal perforation was provided. It is recommended that healthcare providers utilizing bevacizumab review the updated Adverse Events, Other Serious Adverse Events section at: |
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