AVASTIN® (bevacizumab) and tracheo-esophageal fistulas
admin June 29th, 2007
Health Canada and Hoffmann-La Roche Limited have issued a letter to health care professionals warning of the risk of tracheo-esophageal fistula associated with bevacizumab:
- Serious adverse events, including fatal events, of tracheo-esophageal (TE) fistula have been reported in association with use of AVASTIN clinical trials of small cell lung cancer (SCLC), non small cell lung cancer (NSCLC) and esophageal cancer.
- AVASTIN should be permanently discontinued in patients with tracheo-esophageal (TE) fistula or any gastrointestinal fistula. There is limited information on the continued use of AVASTIN in patients with other fistulas.
- In cases of internal fistula not arising in the GI tract, discontinuation of AVASTIN should be considered.