On Friday, November 18, 2011, the FDA released a report that revoked the approval for the use of Avastin as a breast cancer drug. According to FDA commissioner, Dr. Margaret A. Hamburg, Avastin does not help breast cancer patients live longer or control their tumors, but does expose them to serious side effects including high blood pressure and hemorrhaging.

Avastin - Courtesy of http://pharma.about.com

According to Dr. Hamburg:

“This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use,”

Dr. Hamburg went on to say:

“After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.”

The drug is still approved for the treatment of other cancers, therefore it is still available for doctors to use to treat breast cancer as an off-label use. This means some patients who insist on using the drug may still have access to it depending on whether their doctor prescribes the treatment.

Click to review the entire FDA decision.

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