On November 18, 2011, in a 69-page opinion, U. S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, M. D., announced that she withdrew the FDA’s approval of Avastin’s metastatic breast cancer indication.  The agency concluded that the drug was “not shown to be safe and effective in breast cancer patients.”  After reviewing numerous studies, studies concluded women with breast cancer taking Avastin faced severe and life-threatening risks, such as high blood pressure, hemorrhaging, heart failure, and perforations in the nose, stomach, and intestines, without receiving any benefits.  Taking the drug neither extended nor improved quality of life.

Avastin, first indicated for advanced colon cancer in 2004, obtained approval for metastatic breast cancer under the FDA’s accelerated approval program in February 2008.  The accelerated approval program allows tentative approval and early access to promising new drugs or drugs treating serious or life-threatening illness while studies are conducted.  The FDA based its initial decision on results from one clinical trial that suggested the Avastin’s use extended and improved the quality of life.

Between 2008-2010, Genentech, the manufacturer of Avastin, completed two other studies, but the FDA’s Center for Drug Evaluation and Research, the group responsible the approval of Avastin’s breast cancer indication, concluded Avastin did not warrant approval.

Genentech disagreed with this assessment—Avastin generated over $88,000 per patient per year for the company.  They filed a Notice for Opportunity for a Hearing and requested a final decision stemming from the Commissioner.  In a two-day hearing conducted in June 2011, the board voted unanimously 6-0 to withdraw approval of Avastin’s breast cancer indication and the Commissioner agreed with the board’s assessment. Indictions for Avastin’s other uses, advanced colon cancer, lung cancer, kidney cancer, and brain (glioblastoma) cancer were not affected.

Have you used Avastin and suffered a serious, life-threatening side effect?  Any individual or the relative of an individual who has suffered due to Avastin’s side effects is permitted to file a lawsuit.  The lawyers can help you determine whether you are qualified to seek compensation.  You may be eligible to seek reimbursement for medical expenses, compensation for pain and suffering, and punitive damages (compensation granted for losses suffered).

Different states have different legislation regarding medical lawsuits, so it is essential to hire an experienced and effective lawyer who can file the case.  If you need further information about the harmful side effects of Avastin or legal advice concerning personal injury matters, we invite you to contact us or to fill out our form on this website for a free case evaluation.