Bevacizumab Labeling Revised to Include New Risks

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FDAlogoThe FDA recently announced changes made to the bevacizumab (Avastin) package insert regarding new safety concerns. These changes include the following:

  • A new Warning subsection describing the increased risk of ovarian failure in premenopausal patients receiving bevacizumab and chemotherapy and recommendation that females of reproductive potential be informed of the increased risk of ovarian failure prior to starting treatment with bevacizumab
  • Identification of osteonecrosis of the jaw as an adverse reaction of bevacizumab
  • New information regarding the risks of venous thromboembolic event (VTE) and bleeding in patients receiving anticoagulation therapy after a first VTE event while receiving bevacizumab. ■




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