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Bevacizumab's label adds adverse reactions.

A warning about the risk of ovarian failure in premenopausal women has been added to the label for bevacizumab along with new postmarketing data identifying osteonecrosis of the jaw as an "adverse reaction," the FDA announced.

Information about the increased risk of venous thromboembolic events (VTEs) and bleeding associated with bevacizumab in patients receiving anticoagulation therapy after a First VTE event has also been added in the section on Clinical Trial Experience, the FDA said. Bevacizumab - marketed as Avastin by Genentech, a mem ber of the Roche group - is a vascular endothelial growth factor inhibitor approved for the treatment of several different cancers, as a single agent or in combination with other treatments. It was First approved in 2004; a controversial FDA move to withdraw an indication in metastatic breast cancer is pending.

The potential for ovarian failure associated with bevacizumab treatment in premenopausal women is new information. It has been added to the warnings and precautions section of the label and in a new "Females of Reproductive Potential" subsection.

This section now states that the long-term effects of exposure to bevacizumab on fertility are unknown and that women of reproductive potential should be informed about the risk of ovarian failure before starting treatment.

The postmarketing experience section of the label now includes a statement about postmarketing reports of osteonecrosis of the jaw (ONJ) in patients treated with bevacizumab who have not been treated with bisphosphonates. (ONJ has been reported in patients on bisphosphonates.)

The overall incidence of subsequent VTEs was also higher with bevacizumab in a subgroup analysis of patients that received anticoagulants after an initial VTE event: The subsequent VTE rate was 31.5% among those in the bevacizumab-containing arms, compared with 25.6% among those in the chemotherapy-only arms.

Among patients treated with anticoagulants, the overall incidence of bleeding was also higher in the bevacizumab-containing arms, compared with the chemotherapy-only arms: 27.4% vs. 20.9%, respectively

After 3 years, the incidence of new vertebral fractures was 1.5% among those treated with denosumab, compared with 3.9% for those on placebo, a risk reduction of 62%.
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Title Annotation:NEWS FROM THE FDA
Publication:Internal Medicine News
Date:Oct 15, 2011
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