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Avastin Side Effects Lawsuits | Side Effects: Blindness, Heart Attack, Heart Failure, Stroke, Reversible Posterior Leukoencephalopathy Syndrome (RPLS), Severe High Blood Pressure

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Avastin May Cause Blindness, Heart Attacks, Necrotizing Fasciitis, and other Serious Side Effects

Avastin | Lawsuits, Lawyers | Side Effects: Blindness, Heart Attack, Heart Failure, Stroke, Reversible Posterior Leukoencephalopathy Syndrome (RPLS), Severe High Blood Pressure

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:

  • blindness;
  • severe high blood pressure;
  • bleeding and hemorrhage;
  • perforations (or “holes”) in the body, including the nose, stomach, and intestines;
  • heart attack or heart failure;
  • stroke;
  • 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:

  • headache
  • confusion
  • vision problems
  • blindness
  • feeling light-headed
  • fainting
  • 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.

Legal Help for Victims of Avastin

If you or a loved one suffered a serious Avastin side effect while undergoing treatment for breast cancer, you may have valuable legal rights. To discuss your case with one of our Avastin side effect lawyers, please fill out our online form, or call 1-800-YOURLAWYER (1-80-968-7529) today.

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FDA Gives Avastin for Breast Cancer Thumbs Down

Nov 21, 2011 | Parker Waichman LLP
The U.S. Food & Drug Administration (FDA) announced its final decision to revoke Avastin's approval for breast cancer.   In announcing its decision, the FDA cited Avastin's serious side effects, and a lack of evidence showing Avastin will either help them victims of metastatic breast cancer live longer or improve their quality of life.Avastin will remain on the market as a treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme).“This was...

Avastin Label Updated to Include Fertility Issues in Woman, Other Side Effects

Oct 5, 2011 | Parker Waichman LLP
The U.S. Food & Drug Administration (FDA) announced yesterday that new information about several Avastin side effects has been added to the drug's label.  The new information includes a warning that Avastin may impact the fertility of premenopausal women. According to a notice on the FDA website, the Avastin prescribing information now includes: a new "Warning and Precautions" subsection describing the increased risk of ovarian failure in premenopausal patients receiving...

Infection Risk Prompts VA to Drop Avastin as Eye Treatment

Sep 22, 2011 | Parker Waichman LLP
The Department of Veterans Affairs (VA)  will no longer use Avastin to treat age-related,  wet macular degeneration until  it finishes an investigation into blinding eye infections linked to the  treatment.  Doctors with the VA are being urged to use Lucentis, another  - and more expensive - drug made by Genentech that is actually approved for this use.According to an alert issued by the  U.S. Food & Drug Administration (FDA) last month, 12 people in...

Serious, Blinding Eye Infections Linked to Avastin Eye Treatment

Sep 1, 2011 | Parker Waichman LLP
An off-label use of the cancer drug Avastin has been linked to serious eye infections that, in some cases, have resulted in permanent blindness.  All of these eye infections occurred in people who received Avastin injections in the eye to treat wet age-related macular degeneration.The problem with using Avastin in this way is that the drug is only sold in much higher doses than what is needed.  As a result, single vials of Avastin are divided into smaller vials, making it much more...

Avastin Fails to Win Over FDA Panel as Breast Cancer Treatment

Jun 30, 2011 | Parker Waichman LLP
For the second time in about a year, the Food & Drug Administration (FDA) oncology panel has voted to reject Avastin as a breast cancer treatment.   The 6-0 vote was taken yesterday, at the conclusion of a contentious and emotional hearing in which the maker of Avastin tried to persuade the panel that the drug should keep its breast cancer indication.The FDA initially announced in December that it was moving to revoke Avastin's breast cancer approval.  In doing so, the FDA...

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