A drug Avastin gained the Food and Drug Administration’s (FDA) approval for metastatic breast cancer in February 2008. However, the permit couldn’t be deemed as full approval. Now, the FDA has revoked the approval of the drug Avastin stating that it appeared to be unsafe and ineffective for breast cancer patients. This action was taken after conducting a detailed analysis of the medicine.
However, the aforesaid drug will stay in the market for treating other cancers like colon, lung, kidney and brain tumors. Some of Avastin’s risks that came to light included elevated blood pressure, bleeding, hemorrhagin, heart attack and creation of perforations in certain portions of the body like nose, stomach and intestines.
“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,†commented FDA Commissioner Margaret A. Hamburg, M.D.
This decision was based on detailed records, clinical trials and a 2-day hearing conducted in June 2011. The initial permission to use this medicine was an accelerated approval after which 2 additional trails were undertaken.
As per the data from these tests, it was found that the drug Avastin did not seem effective enough to increase a patient’s survival and did not outdo the risks associated with its consumption either.
Genentech is the manufacturer of Avastin.