The cancer therapy drug Avastin is manufactured by Genentech, Inc., a member of the Roche family of companies. Roche has earned nearly $6 Billion Dollars in sales of Avastin in 2009 alone. Avastin, though originally formulated for treatment of colon cancer, was approved for use in cases of breast cancer in 2008 under the Food and Drug Administration’s (FDA) “accelerated approval” program. Under the “accelerated approval” program a drug may be approved even though further information is required to determine if the drug provides a meaningful benefit to the patient.
FDA Begins Process to Remove Breast Cancer Indication from Avastin Label
In December 2010 the FDA announced that it wants to remove the breast cancer indication for Avastin, stating that the drug is neither safe nor effective for the treatment of breast cancer and the risks associated with the drug are unacceptably high. The “agency is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicates that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.”
Despite the recommendation of the FDA, Genentech has refused to voluntarily remove the breast cancer indication.
Avastin and Age-Related Macular Degeneration (AMD)
Avastin has been used off-label to treat AMD. However, a study done at John Hopkins University has revealed that patients with AMD who were treated with Avastin were more likely to suffer a stroke than patients who were treated with another drug.
The Side Effects
Some of the most serious side effects of Avastin use can result in hospitalization and/or death; they include, but are not limited to:
- Gastrointestinal perforation (holes in the stomach)
- Slow or incomplete wound healing
- Severe bleeding (including vomiting or coughing blood and bleeding in the brain)
- Blood clots
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS), characterized by high blood pressure, headaches, confusion, seizures, and vision loss from swelling of the brain
What You Can Do If You Or a Loved One Has Been Injured by Avastin
If you or someone you know has been treated for breast cancer with the drug Avastin and experienced any of the side effects associated with this drug, it is important to seek medical attention as soon as possible. Anyone suffering from the side effects of Avastin may have a right to seek compensation for their losses. Our attorneys are reviewing new cases of those injured and are ready and able to assist. Anyone injured by Avastin may contact us directly at 1-800-434-8399, or contact us through our website at www.lawyernc.com.