Advocacy & Practice Updates — Advocacy & Practice
FDA Announces Avastin Safety Labeling Changes
Clinical trial experience information updated
The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has announced a safety labeling change for Avastin (bevacizumab, Genentech, Inc, South San Francisco, CA) for intravenous infusion.
In Avastin's drug safety labeling under "Adverse Reactions," the FDA reports that the clinical trial experience has been revised to provide information on the incidence of post-treatment vascular events.
To report an adverse event or side effect:
- Download the form or call 800-332-1088 to request the reporting form. Complete and return it to the address on the form, or fax to 800-FDA-0178.
Updated: September 15, 2014