FDA Rejects Avastin as a Breast Cancer Remedy
Advisers to the Food and Drug Administration (FDA) voted unanimously to halt the use of Avastin for the treatment of breast cancer.
An emotionally charged two-day hearing in Silver Springs, Maryland ended with federal advisers voting to revoke the approval of the world's top selling cancer drug, Avastin, (Bevacizumab) as a treatment for women with advanced breast cancer.
Several patients that had used Avastin for the treatment of breast cancer told the FDA's Oncologic Drugs Advisory Committee they felt it is "a miracle drug" while cancer advocates pointed out that it had caused adverse side effects for other users. Finally, the committee concluded that the research study conclusively showed that the drug, which can cost up to $88,000 a year per patient, failed to significantly extend patients' lives, or improve their quality of life.
One California patient, who has been on the drug for eight years, testified that the the decision is, essentially for her, a death sentence.
The advisers' decision related to breast cancer, According to the FDA website, will not affect Avastin's approved indications for use in the treatment of several other cancers, including colon cancer, lung cancer, brain cancer, and renal cancer.
Avastin had originally been given "fast-track" approval by the FDA for use in breast cancer cases.
Avastin Recall - Danger Alert
Avastin (Bevacizumab), a drug used in chemotherapy for cancer (particularly for breast cancer) and prescribed by some doctors for the treatment of macular degeneration, was recently recalled by the FDA. According to the New York Times, this sets the stage for an overall recall, which is expected to occur later this year, probably in September.
Avastin has been found to be ineffective in helping breast cancer victims, and Avastin has been linked to a dangerously high incidence of cardiac failure/arrest/death, digestive tract perforations (holes in intestines or stomach), and potentially fatal bleeding in the lungs. Avastin is also prescribed as a chemotherapy treatment for other types of cancer, and this recall may not affect such usage at this time. More will be known after the Food and Drug Administration (FDA) completes its review of Avastin.
Avastin received special 'accelerated approval' by the FDA in 2008, in response to demand for the drug by doctors wishing to try it as a last-ditch measure to cure the often fatal cancer.
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Posted the on the Genentech website page for Avastin are the following warnings:
WARNINGS
- Gastrointestinal (GI) perforation: Avastin can result in the development of a potentially serious, and sometimes fatal side effect called GI perforation, which is the development of a hole in the stomach, small intestine or large intestine. Symptoms may include abdominal pain, nausea, vomiting, constipation, and fever. Patients must stop Avastin for at least 28 days before voluntary surgery.
- Surgery and wound healing problems: Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality.
- Severe bleeding: Treatment with Avastin can result in serious and sometimes fatal bleeding. This includes coughing up blood, bleeding in the stomach, vomiting blood, bleeding in the brain, nosebleeds and vaginal bleeding. People who have recently coughed up blood or have serious bleeding should not receive Avastin.
Contacting an Avastin Lawyer
If you or a loved one has suffered congestive heart failure, heart attack, unusual bleeding or other severe medical complication while taking Avastin, contact an experienced attorney at Viles and Beckman to determine whether you have sufficient cause to file a personal injury lawsuit in order to obtain financial compensation for medical expenses, lost wages or pain and suffering. If you have lost a loved one as a result of Avastin side effects, Viles and Beckman's attorneys can advise you regarding the filing of a wrongful death lawsuit to bring those responsible to justice. Fill out the FREE CASE REVIEW form on the right side of this page, or call 1-800-648-4537 today to speak to an Avastin lawyer at Viles and Beckman, LLC.
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