Have you or a loved one been harmed by the cancer drug Avastin? In December 2010, the U.S. Food & Drug Administration (FDA) announced it would begin the process of removing the breast cancer indication from the Avastin label, saying the benefits of the drug did not outweigh its risks. According to the FDA, possible serious Avastin side effects include:
- severe high blood pressure;
- bleeding and hemorrhage;
- perforations (or “holes”) in the body, including the nose, stomach, and intestines;
- heart attack or heart failure;
- reversible posterior leukoencephalopathy syndrome (RPLS) (a neurological condition).
- necrotizing fasciitis (life-threatening infection of the soft tissue).
On April 29, 2013, Health Canada issued an important update to the safety information regarding the use of Avastin. The communication states that necrotizing fasciitis has been reported in patients receiving Avastin in both clinical trials and in the post-marketing setting. Some of the cases have been fatal.
Necrotizing fasciitis is a rare, but life threatening infection of the soft tissue, characterized by rapidly spreading necrosis of superficial fascia and subcutaneous tissue. Those with compromised immune systems or who are diabetic face a greater risk of developing necrotizing fasciitis.
Avastin for Breast Cancer
Avastin, the best selling cancer drug in the world, was the first approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor. It was originally approved in 2004 to treat metastatic colon cancer. Since then, Avastin has been approved to treat breast, lung, kidney, and brain (glioblastoma) cancers. Avastin is one of the most expensive drugs on the market, costing between $50,000 and $100,000 a year. In fact, many patient advocates have criticized the high cost, because Avastin neither cures cancer nor significantly prolongs life.
When the FDA approved Avastin to treat metastatic breast cancer in 2008, it did so against the recommendation of its advisory panel. Avastin for breast cancer was approved under the FDA’s accelerated approval program, based on initial positive studies. Companies then have to submit additional data to gain full approval. Avastin’s provisional approval for breast cancer was based on an initial trial that showed it lengthened the time until the disease worsened, though it did not prolong the women’s lives by a statistically significant amount.
In 2010, results from four new trials that enrolled more than 3,000 women found no significant reduction in disease progression or death among those who took Avastin along with chemotherapy. In July 2010, after reviewing all available data, an independent advisory committee, composed primarily of oncologists, voted 12-1 to remove the breast cancer indication from Avastin’s label.
In December 2010, the FDA announced it was recommending that the advanced breast cancer indication for Avastin be revoked. The agency said it determined that the data indicate that Avastin 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.
According to a statement from the FDA, the recommendation is only the first step in revoking Avastin’s breast cancer indication. The drug itself is not being removed from the market and the FDA’s action will not have any immediate impact on its use in treating breast cancer. The action will not affect the approvals for colon, kidney, brain, and lung cancers, the FDA said.
Genentech Inc. (a subsidiary of Roche), the maker of Avastin, said it would request a hearing to contest the decision. If the FDA grants a hearing, there is no set date for when this would occur and until the procedure is concluded, Avastin will remain FDA-approved in breast cancer.
Avastin Side Effects
Our Avastin injury lawyers believe that because of its significant risks, Genentech should stop marketing Avastin as a treatment for advanced breast cancer immediately. Many Avastin side effects are life-threatening. For example, Avastin has caused some patients to develop holes in the colon called gastrointestinal perforation. This Avastin side effect, which requires surgery to repair, can sometimes lead to other side effects, including intra-abdominal infections, impaired wound healing, and internal bleeding.
Another side effect has been blindness when Avastin has been used off-label to treat macular degeneration. The FDA is warning that the Genentech cancer drug, when repackaged for eye use, has caused a “cluster of serious eye infections,” including some that left patients blind. The tainted Avastin was traced to a single Hollywood, FL, pharmacy that had repackaged Avastin from 4-ml single-use vials into 1-ml syringes. Meanwhile, the New York Times reports that another, smaller cluster of infections cropped up in Tennessee.
Another Avastin side effect is reversible posterior leukoencephalopathy syndrome (RPLS), a rare but serious neurological disorder where the brain becomes inflamed and swells. This rare side effect may occur within hours of the first Avastin dose, or this side effect may appear up to a year after Avastin treatment is started. Avastin patients who experience the following side effects may be suffering from this disorder:
- vision problems
- feeling light-headed
- seizure (blackout or convulsions)
Avastin has also been linked to bleeding that can lead to stroke or death (especially in lung cancer patients), heart failure in certain patients, and kidney damage.
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