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Avastin Lawsuit

Avastin eye injections linked to “silicone floaters” or bubbles left in the eyes of cancer patients.

When injected into the eyes of cancer patients, the chemotherapy drug Avastin (generic: bevacizumab) is placed in syringes that are lubricated with silicone oil. This silicone has been reported to leak into the eyes of some patients, leaving behind silicone floaters that look like bubbles.

Free Confidential Lawsuit Evaluation: If you or a loved one had side effects from Avastin eye injections because silicone floaters or bubbles were left in your eyes, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.

What is Avastin?

Developed by Roche Holding AG, Avastin was approved by the FDA in 2004 for the treatment of certain varieties of lung, brain, kidney, colon and breast cancers when combined with chemotherapy. It was then granted accelerated approval for use with paclitaxel to treat breast cancer in February 2008. The medication works by restricting blood flow to tumors, thereby starving them and inhibiting their growth.

“Off-Label” Uses

In addition to its approved indications, Avastin has also been found to be effective at treating a number of eye-related diseases including:

  • Macular degeneration
  • Retinal vein occlusion
  • Diabetic macular edema
  • Diabetic retinopathy

These are “off-label” uses of Avastin, which means they are treatments that have not yet been approved by the FDA. Doctors are allowed to use and prescribe drugs for off-label purposes, but it is illegal for pharmaceutical companies to market products for such indications.

Avastin Silicone Floaters

In order for Avastin to be used for treating eye diseases, the medication is placed into syringes (many of which are not intended for eye injections) by compounding pharmacies, which are then sent to ophthalmologists to treat their patients. The problem is that these syringes are lubricated with silicone oil, which has been found to migrate from the surface of the needle and mix with liquid Avastin.

When the silicone oil mixes with Avastin, silicone particles or “floaters” could end up in a patient’s eyes, leading to a variety of complications. These silicone floaters looks a lot like air bubbles in patients’ eyes.

Complications of Silicone Floaters

  • Increased intraocular pressure
  • Inflammation
  • Infection (endophthalmitis)
  • Retinal tearing
  • Retinal detachment
  • Cataract formation
  • Glaucoma (increased pressure in the eye)
  • Hypotony (reduced pressure in the eye)
  • Corneal damage
  • Vision loss/blindness
  • Other sight-related complications

Are There Other Side Effects?

In addition to silicone floaters and/or bubbles from Avastin eye injections, the medicine has been linked to the following side effects:

  • Severe high blood pressure
  • Neurological damage
  • Eye infections & inflammation
  • Streptococcus endophthalmitis
  • Heart attacks
  • Heart failure
  • Kidney damage
  • Hypertension
  • Impaired wound healing
  • Blood clots
  • Bleeding
  • Hemorrhaging
  • Pulmonary embolism (PE)
  • Perforations in the nose, stomach and intestines
  • Jaw decay
  • Osteonecrosis of the jaw (ONJ)
  • Stroke
  • Ovarian failure
  • Worsening of coronary artery disease
  • Worsening of peripheral artery disease
  • Reversible Posterior Leukoencephalopathy Syndrome, a neurological disease characterized by headache, vision loss, confusion, and seizures
  • Death

Ovarian Failure

In response to information stating that Avastin may affect fertility in some women, the FDA announced in October 2011 that it was requiring warning labels of the drug to be updated to include information about the risk of ‘ovarian failure.’ The administration has advised doctors to counsel women of childbearing age about the possibility that taking Avastin could potentially cause their ovaries to stop releasing eggs prematurely. Signs and symptoms of Avastin-induced ovarian failure may include:

  • irregular periods (different length or bleeding or change in flow)
  • hot flashes
  • night sweats
  • decrease in sex drive
  • irritability
  • painful sex
  • thinning and drying of vagina

The data leading up to the FDA’s decision to update Avastin’s warning labels came from a clinical trial involving 179 women with colon cancer who were being treated with chemotherapy (roughly half of whom also took Avastin). The study results found that nearly 35% of women from the Avastin group experienced ovarian failure, compared to just 2% of women receiving chemotherapy alone. Ovarian function returned in approximately 20% of the participants after discontinuing treatment with Avastin, but the long-term effects of the drug continue to remain largely uncertain.

Stroke

According to new research conducted by a team at Johns Hopkins University, using Avastin in an ‘off-label’ capacity to treat wet age-related macular degeneration (AMD) was highly correlated with an increased risk of stroke and death when compared to Lucentis, a drug specifically designed to treat the condition. AMD affects more than two million Americans over the age of 50, and is the leading cause of blindness in the United States. That number is expected to double by the year 2020, as members of the ‘baby boomer’ generation continue to age.

When compared side by side, Avastin users were linked with an 11% increased risk of death and a 57% increased risk of stroke over Lucentis users. Avastin has not been approved by the FDA to treat AMD, but has been found in recent studies to be just as effective as Lucentis. The main difference between the two – as well as the likely motivation for prescribing Avastin in many situations – is that Avastin is $50 a shot while Lucentis is approximately $2,000 a shot.

Symptoms of a stroke caused by Avastin may include:

  • trouble with walking
  • difficulty speaking and understanding others
  • paralysis or numbness on one side of the body or face
  • trouble with seeing in one or both eyes
  • headache

Death

Another recent study published in the Journal of the American Medical Association (JAMA) found that Avastin may significantly increase the risk of death in some cancer patients. According to the research, the risk of death from Avastin is 2.5% when used with chemotherapy compared to a 1.7% death rate among patients being treated with chemotherapy alone.

Avastin Breast Cancer Approval Pending

In other developments, an independent advisory panel has unanimously recommended that Avastin’s approval for breast cancer be revoked. The recommendation was based on data from four clinical trials that found the drug failed to extend the lives of metastatic breast cancer patients. Avastin did show the ability to delay the onset of the condition by one to three months, but at the risk of potentially life-threatening side effects. Regardless of whether the FDA revokes Avastin’s approval for the treatment of breast cancer, the drug will remain on the market indefinitely to treat the other forms of cancer for which it is approved. Despite the controversy surrounding the drug, Avastin has enjoyed widespread success and is currently the country’s best-selling cancer medication, with annual sales topping $7 billion.

Do I have an Avastin Lawsuit?

The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Avastin lawsuits. We are handling individual litigation nationwide and currently accepting new eye injection side effects cases in all 50 states.

Free Case Evaluation: Again, if you had complications from Avastin eye injections because silicone floaters or bubbles were left in your eyes, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

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