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FDA Orders More Changes to Avastin Label

By order of the U.S. Food and Drug Administration, the label for the popular cancer drug, Avastin, was updated on September 30 to reflect a number of adverse events, including the risk of ovarian failure and venous thromboembolic events (VTE). The drug’s new label also includes the addition of new information regarding the risk for developing osteonecrosis of the jaw.

The new warning regarding the risk for ovarian failure was prompted by the results of a study related to premenopausal patients who were simultaneously receiving both Avastin and chemotherapy. The study revealed that ovarian failure occurred in 34 percent of women receiving the combo of Avastin (bevacizumab) and chemo, compared to the 2 percent of women receiving only chemo treatments.

Avastin’s updated label now states that prior to beginning treatment, women with childbearing potential should be warned of the risk for ovarian failure.

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