Bevacizumab label now warns of ovarian, osteonecrosis risks
The FDA has announced changes in the labeling of bevacizumab (Avastin), a vascular endothelial growth factor-specific angiogenesis inhibitor indicated for the treatment of metastatic colorectal cancer, nonsquamous non-small cell lung cancer, metastatic breast cancer, glioblastoma, and metastatic renal cell carcinoma (www.accessdata.fda.gov/drugsatfda_docs/label/2011/125085s225lbl.pdf).
On September 30, 2011, the following changes were made to the bevacizumab package insert:
- A new Warning subsection added to the Warnings and Precautions section of the package insert describes the increased risk of ovarian failure in premenopausal patients receiving bevacizumab and chemotherapy, and recommends that females of reproductive potential be informed of the increased risk of ovarian failure prior to starting treatment with this drug.
- Osteonecrosis of the jaw is now identified as an adverse reaction of bevacizumab in the postmarketing experience subsection of the Adverse Reaction section of the package insert.
- Information has been updated in the Clinical Trial Experience section regarding the risks of venous thromboembolic (VTE) events and bleeding in patients receiving anticoagulation therapy after the first VTE event while receiving bevacizumab.
Details are available at www.fda.gov/AboutFDA/CentersOffices/CDER/ucm274394.htm.