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Avastin Label Updated to Include Fertility Issues in Woman, Other Side Effects

Oct 5, 2011 | Parker Waichman LLP

The U.S. Food & Drug Administration (FDA) announced yesterday that new information about several Avastin side effects has been added to the drug's label.  The new information includes a warning that Avastin may impact the fertility of premenopausal women.

According to a notice on the FDA website, the Avastin prescribing information now includes:

  • a new "Warning and Precautions" subsection describing the increased risk of ovarian failure in premenopausal patients receiving Avastin and chemotherapy and recommendation that females of reproductive potential be informed of the increased risk of ovarian failure prior to starting treatment with Avastin,
  • identification of osteonecrosis of the jaw as an adverse reaction of Avastin, and
  • new information regarding the risks of venous thromboembolic events (VTE) and bleeding in patients receiving anti-coagulation therapy after first VTE event while receiving Avastin.

According to the FDA, ovarian failure was seen in patients enrolled in a clinical trial.  Cases of ovarian failure, defined as amenorrhea lasting 3 or more months, were identified in 34% (32/95) of women receiving Avastin in combination with chemotherapy compared with 2% (2/84) of women receiving chemotherapy alone.  After discontinuation of Avastin treatment, recovery of ovarian function was demonstrated in only 22% of these women.

Avastin is approved to treat metastatic colon cancer, non-small cell lung cancer, kidney cancer and glioblastoma multiforme, an incurable brain cancer.

Avastin was once approved as a treatment for advanced breast cancer, but the FDA recently revoked approval for that indication.  In doing so, the FDA said there was little evidence that Avastin improves survival time for breast cancer patients, and cited its association with serious complications, including perforations of the intestines and other parts of the body, bleeding, and cardiovascular problems.

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