FDA Revokes Approval of Avastin for Breast Cancer

The U.S. Food and Drug Administration has revoked its approval of the drug Avastin for breast cancer on the grounds that it has not been shown to be safe and effective for that use, according to an FDA news release.

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Avastin will continue to be available as an approved treatment for certain kinds of colon, lung, kidney and brain cancers.

FDA Commissioner Margaret A. Hamburg, MD, said a review of the literature showed there is no evidence Avastin will delay tumor growth, help patients live longer or improve their quality of life. She said the unproven benefit of Avastin for breast cancer does not justify the “potentially life-threatening side effects,” according to the release.

Avastin’s risks include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and perforations in different parts of the body such as the nose, stomach and intestines, according to the release.

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