APPROVAL OF BREAST CANCER TREATMENT DRUG REVOKED BY FDA
November 1, 2011
Nearly 30,000 women suffer from breast cancer each year. Avastin has become a popular drug for the treatment of breast cancer with approximately $1 billion in sales annually.
However, the Food and Drug Administration (FDA) has recently revoked its approval of the drug explaining that further research has uncovered that the drug is actually an unsafe product for patients suffering from breast cancer. Interestingly, Avastin was approved for breast cancer treatment in 2008 as part of an accelerated program which pushed the drug through to FDA approval without full evidence of the drug’s safety and effectiveness.
According to the clinical trials, the drug was not helping those women who were suffering from breast cancer. Instead the drug exposed them to very serious side effects, including high blood pressure and serious bleeding. Though the drug did work well for some patients, leaving it on the market for the treatment of breast cancer would put many women at risk of the dangers of the drug.
Avastin will still be available to treat other forms of cancer, just not breast cancer. As a result, it is possible that a doctor may prescribe the drug “off-label,” meaning other than for the purpose it is approved for.
However, now that the risks of this drug have been found to outweigh the benefits, Oregon doctors are on notice that doing so could be considered a prescription error. If the use of the drug does in fact cause serious internal bleeding from such a prescription error, then the doctor may be held accountable.
Source: The New York Times, “F.D.A. Revokes Approval of Avastin for Use as Breast Cancer Drug,” Andrew Pollack, Nov. 18, 2011