Because clinical trials have shown that the drug Avastin does not help breast cancer patients to live longer, but does expose them to potentially serious heart-related side effects, the U.S. Food and Drug Administration (FDA) has revoked Avastin’s approval for use as a breast cancer drug. There has not been an Avastin recall, however. The drug remains on the market as a treatment for other cancers, and therefore can still be prescribed off-label to breast cancer patients.
What Is Avastin? When Is It Prescribed?
Avastin is the brand name for the drug bevacizumab. Made and sold by Genentech, a wholly owned subsidiary of Swiss pharmaceutical giant Hoffman-La Roche, this prescription medication is used to treat colorectal, lung, renal, brain, and other forms of cancer. First approved in February 2004, Avastin is administered intravenously in 100mg or 400mg doses.
Bevacizumab hampers the creation of new blood vessels (angiogenesis) by inhibiting a necessary protein from creating new blood. This limits the growth of malignant tumors by denying them nutrients, which is why the FDA approved it for use against metastasized cancers. Avastin is also used (albeit without FDA approval) for treating macular degeneration, a disease caused by excess blood in the retinas.
In 2008, against its own advisory panel’s recommendations, the FDA approved Avastin for metastasized breast cancer based on clinical data generated by an accelerated approval process. The panel believed the drug merely slowed tumor growth without increasing survival rates.
A 2010 study of 3,000 women using Avastin for breast cancer showed that the drug was ineffective at prolonging life expectancies. As a result, an advisory committee of oncologists voted twelve to one to remove Avastin’s breast cancer indication.
On Nov. 18, 2011, the FDA followed suit and revoked Avastin’s indication for metastic breast cancer due to its ineffectiveness. There hasn’t been an Avastin recall, however. The drug remains on the market as a treatment for other cancers, and therefore can still be prescribed off-label to breast cancer patients. Not all breast cancer patients will be able to afford it, though. It costs around $88,000 a year, but while Medicare will cover it, private insurers may not cover it for breast cancer patients any longer.
In February 2012, regulators in Europe and in the United States discovered that someone had sold 19 medical practices counterfeit Avastin. They traced the products to a distributor called “Quality Specialty Products” (QSP), which may have also worked under the name “Montana Health Care Solutions.” Another company called Volunteer Distribution of Gainsborough, Tennessee may have distributed QSP’s counterfeit Avastin. The FDA’s Web site contains images of the packages QSP used. The counterfeit Avastin has “Roche” printed on its labels instead of “Genentech,” and the lots numbers are B6010, B6011, B86017. Genentech uses six-digit batch numbers with no letters, and it includes expiration dates on its products’ labels. The counterfeit Avastin is mostly harmless so long as patients don’t use it in high doses, but it lacks the bevacizumab that is meant to treat cancer. There is no reason to believe that the counterfeit drugs will lead to an Avastin recall.
Avastin Side Effects
Although no Avastin warning is in effect, nor has there been an Avastin recall, research has shown the drug causes some severe, life-threatening side effects. On top of its prohibitive cost and ineffectiveness at working as indicated, Avastin users experience the kinds of symptoms one would expect when blood creation is inhibited, for the body requires new blood vessels for healing. Here are some of Avastin’s side effects:
- worsening of coronary artery disease
- worsening of peripheral artery disease
- perforation of various linings such as those in the nose, stomach, kidneys, and bowels
- heart attacks
- Reversible Posterior Leukoencephalopathy Syndrome, a neurological disease characterized by headache, vision loss, confusion, and seizures
- necrotizing fasciitis (flesh-eating disease)
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file an Avastin lawsuit on your behalf if necessary.
If you have taken Avastin and believe it harmed you, contact RLG today.