The United States Food and Drug Administration (FDA) recently announced it has removed its conditional approval of cancer drug Avastin (bevacizumab) for the treatment of breast cancer. Despite proven effectiveness in treating brain, kidney, colon, and lung cancer, the FDA says the drug has not been proven effective or safe for breast cancer patients after clinical trials.
According to the FDA’s 69-page report, Avastin presents several risks to breast cancer patients including heart attack or heart failure; the development of perforations in the nose, stomach, and instestines; and severe high blood pressure. FDA Commisioner Margaret A. Hamburg, M.D. said, “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.”
Avastin will remain on the market for treating other types of cancer, but the drug’s sponsor Genentech must remove from their product labels that it is for the treatment of breast cancer. Doctors may still prescribe Avastin as a treatment for breast cancer; however, insurance companies may not pay for it now that it is no longer FDA-approved. According to CBSNews, “including infusion fees, a year’s treatment with Avastin can run $100,000.” Consumer Reports indicates that Medicare will continue to pay for the medication.
MSNBC reports the United Kingdom’s public health service also recently made a similar finding regarding Avastin for breast cancer, “citing its high cost and limited benefit.” Barbara Brenner, director of advocacy group Breast Cancer Action said the group agrees with FDA’s decision. “It’s never been shown to improve survival or quality of life. We know that people will be disappointed, but science has to dictate where we go with drug approval,” she said.
While using any prescription drug – including the breast cancer drug Avastin – may have side effects, consumers have a reasonable expectation that their treatment plan should be more helpful than harmful. If you or a loved one suffered severe side effects from a prescription drug, a defective drugs lawyer may be able to help you pursue compensation. Call 1-888-BURNETTI for more information.