Avastin Label Updated to Include Ovarian Failure, Other Side Effects

The label for the cancer drug <"http://www.yourlawyer.com/topics/overview/Avastin-Side-Effects-Lawyers-Lawsuit-Attorney">Avastin (bevacizumab) has been updated to include a warning that it may impact a woman’s fertility. According to a notice posted on the U.S. Food & Drug Administration (FDA) website, the Avastin label will also be updated to include information about other side effects, including osteonecrosis of the jaw, risk of venous thromboembolic (VTE) events, and bleeding in patients receiving anticoagulation therapy after a first VTE event.

According to the FDA notice, information on ovarian failure in premenopausal women has been added to the “Warnings and Precautions” section of the Avastin label. According to the new label, cases of ovarian failure, defined as amenorrhea lasting 3 or more months, were identified during a clinical trial. In that study 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 those women.

Information about osteonecrosis of the jaw (dead jaw syndrome) was added to the ‘Adverse Reactions” section of the label. According to the FDA, the disorder was noted in patients receiving Avastin but not bisphosphonates in the postmarketing setting. Dead jaw syndrome is a painful bone disease in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. It is a possible side effect of bisphosphonate treatment, which some cancer patients undergo to prevent bone metastasis.

Finally, the FDA said a risk of VTE events and bleeding in patients receiving anti-coagulation therapy has been noted in the “Clinical Trial Experience” section of the Avastin label. According to the FDA, in one clinical trial, overall incidence of first VTE was higher in the Avastin containing arms (13.5%) than the chemotherapy alone arms (9.6%). Among the patients treated with anticoagulants following an initial VTE event, the overall incidence of subsequent VTEs was also higher among the Avastin treated patients (31.5% vs. 25.6%). In this subgroup of patients treated with anticoagulants, the overall incidence of bleeding was higher in the Avastin treated arms than the chemotherapy arms.

Avastin is approved to treat a number of cancers, including metastatic colon cancer, non-small cell lung cancer, kidney cancer and glioblastoma multiforme, an incurable brain cancer. The FDA recently revoked Avastin’s approval to treat advanced breast cancer, after finding t it was not clinically beneficial, effective or safe for treating that disease.

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