- 1 Side Effects of Avastin
- 2 Avastin for Eye Disease and Macular Degeneration
- 3 Off-Label Use of Avastin
- 4 How is Avastin Injected into the Eyes?
- 5 Risks of Avastin Eye Injections
- 6 Side Effects of Intravitreal Avastin Injections
- 7 Avastin on the Market
- 8 Avastin Silicon Floaters and Contamination in the Eye
- 9 Silicone-Laced Avastin Eye Injections
- 10 FDA Warnings for Avastin Eye Injections
- 11 Avastin Lawsuits
- 12 Filing an Avastin Lawsuit
- 13 Steps to Filing an Avastin Lawsuit
- 14 Get Legal Assistance for Avastin Lawsuits
Avastin – generic name Bevacizumab – is classified as an “anti-angiogenesis” and “monoclonal antibody” drug. It is used in the treatment of:
- Metastatic rectal or colon cancer – the drug is used as part of a combination chemotherapy regimen
- Non- small cell, non-squamous lung cancer
- Metastatic renal cell carcinoma
- Metastatic breast cancer – the drug is used as part of a combination chemotherapy regimen
- Glioblastoma (GBM)
The drug works by blocking vascular endothelial growth factor (VEGF) – a certain type of protein – which thereby decreases the blood supply to the tumor and slows the growth of the tumor.
It should be noted that if Avastin has been approved for one use, health care professionals may use it for other problems as well if they believe that it may be beneficial to the patient.
Avastin is administered through an infusion into a vein, with the first dose administered over 90 minutes. The time of the infusion can be eventually shortened to 30 minutes if the patient tolerates the drug well.
The amount of Avastin that patients receive depends on a large number of factors, including their weight and height, their general overall health or if they have other health conditions, and the type of cancer or condition that is being treated. The patient’s dose and schedule will be determined by their doctor.
Side Effects of Avastin
Here are a few important things you should keep in mind about the side effects of Avastin:
- Most people do not experience all of the side effects that are listed.
- In most cases, side effects of the drug are predictable when it comes to their onset and duration.
- Generally, side effects are reversible and will go away after you have completed your treatment.
- Many options are available to help in minimizing or preventing side effects.
- There is no link between the severity or presence of side effects and the drug’s effectiveness.
- There is no information as to how frequently the adverse reactions patients experience may be attributed to Avastin alone. This is due to the fact that in clinical studies, the drug was used in combination with other medications for chemotherapy.
Here is a look at some of the common side effects of Avastin that patients experience (they occur in greater than 30% of patients):
- Generalized weakness
- Abdominal pain
- Nausea and vomiting
- Mouth sores
- Poor appetite
- Hair loss
- Upper respiratory infection
- Low white blood cell count – this can increase the risk for infection
Some of the less common side effects (occurring in roughly 10 to 29% of patients who receive Avastin) include the following:
- Shortness of breath
- Muscle aches and pains
- Weight loss
- High blood pressure
Rare but serious complications brought on by Avastin therapy include:
- Gastrointestinal perforation/wound healing complications/fistula formation
- Severe high blood pressure, or hypertensive crisis
- Nephrotic Syndrome, which is a condition that is marked by high protein levels in the urine (proteinuria), swelling, especially around the eyes, hands and feet, and low protein levels in the blood. Nephrotic Syndrome is caused by damage to the glomeruli, which are tiny blood vessels in the kidney that filter excess water and waste from the blood and send them to the bladder as urine.
- Congestive heart failure in patients who have received treatment in the past with radiation therapy to the chest wall, or anthracycline based chemotherapy.
Avastin for Eye Disease and Macular Degeneration
Doctors use Avastin as an in-office treatment for diabetic retinopathy, macular degeneration, and retinal vein occlusion. In fact, the drug is used to treat a wide range of eye and retinal diseases, such as age-related macular degeneration (AMD), which is the primary cause of blindness in people over 50 in the United States.
This condition is caused by the breakdown of the retina’s central portion which is called the macula. This is the part of your eye that is highly sensitive and works like the film in a camera. Avastin is also used in the treatment of central retinal vein occlusion (CRVO) and diabetic macular edema.
Off-Label Use of Avastin
The drug was not initially developed for the treatment of eye conditions. Based on clinical trial results demonstrating its effectiveness and safety, the US Food and Drug Administration (FDA) approved Avastin as a drug for chemotherapy for treating of metastatic colorectal cancer.
As a condition of approval, the drug’s manufacturer produced a label that explains the indications, benefits, and risks of Avastin. On the label, it is included that Avastin works by blocking VEGF, as mentioned earlier. When the growth of VEGF is slowed or prevented, it helps in preventing further growth of the blood vessels that are required by cancer to continue growing.
Once a medication or device is approved by the FDA, it may be used “off-label” by doctors for other purposes. Ophthalmologists around the world are now resorting to Avastin off-label use for the treatment of conditions such as AMD as studies indicate that VEGF is one of the causes of abnormal vessel growth that results with these conditions.
A large number of patients who receive these treatments have more normal-appearing maculas and less fluid, which helps in improving their vision. Eye specialists also use Avastin in some diabetic patients as well as those who suffer from retinal vein occlusion.
How is Avastin Injected into the Eyes?
After the doctor uses anesthesia to dilate the pupils and numb the eye, the medication is injected into the jelly-like substance in the eye’s back chamber called the vitreous. Your doctor may continue using Avastin to inject into your eye as required at regular intervals – roughly every 4 to 6 weeks. Your ophthalmologist will inform you about how often you will need to receive the Avastin injection, and for how long.
Risks of Avastin Eye Injections
Ophthalmologists believe that there is a very low risk of complications for patients suffering from eye infections. On average, patients who received Avastin for the treatment of eye conditions are typically healthier than cancer patients who receive the drug.
They also receive a dose that is significantly smaller only inside their eye. Clinical trials of similar drugs are ongoing as well as studies of patients who are receiving off-label Avastin treatment.
One study of patients who received intravenous Avastin treatment reported only a mild blood pressure elevation. Another study of patients who receive intravitreal Avastin treatment (which means that the drug is injected into the eye) did not have these elevations or any of the other serious problems that patients with cancer suffer from.
It is important to understand that the benefits and risks of intravitreal Avastin treatment for eye conditions are still relatively unknown. It is also, important to note that, whenever a medication is administered to numerous patients, it may cause a few coincidental life-threatening issues which may have no relationship to the treatment they are receiving.
For example, diabetic patients are already at increased risk for strokes and heart attacks. If one of the patients receiving Avastin treatment suffers a stroke or heart attack, it could be caused by diabetes and not the drug.
Side Effects of Intravitreal Avastin Injections
First off, when receiving intravitreal eye injections using Avastin, your condition may not improve and may even worsen.
These complications could cause a decrease in vision or even legal blindness. A number of other additional procedures may be warranted to treat these complications. During phone calls or visits to your doctor’s office, your doctor or eye technician will discuss potential side effects.
No matter what the medication, it has the potential to result in allergic reactions in a small number of people. Symptoms of an allergic reaction can include itching, hives, shortness of breath, rashes and in rare cases, death.
Generally, it is more likely that allergic reactions will occur in people who are allergic to other drugs, foods, and things that are present in the environment, like grass or dust. If you are allergic to foods, medicines or other things, or if you have asthma, you should let your doctor know.
Possible complications and side effects of administration of Avastin include, but are not limited to:
- Formation of cataracts – clouding of the eye lens
- Retinal detachment
- Glaucoma – increased pressure in the eye
- Damage to the retina or cornea
- Hypotony – lowered pressure in the eye
It is also possible that endophthalmitis, or an eye infection, might occur. Any of these rare complications may result in severe or permanent loss of vision.
Patients who receive an Avastin injection may experience side effects that are less severe related to the preparation procedure. These side effects may include pain in the eye, vitreous floaters, bloodshot eyes or subconjunctival hemorrhage, inflammation of the eye, swelling or irregularity of the cornea, and disturbances in vision.
Avastin on the Market
Due to the fact that clinical trials have shown that Avastin does not help patients with breast cancer to live longer and exposes them to potentially serious side effects that are related to the heart, the FDA revoked the approval of Avastin for use as a drug for treating breast cancer.
However, there has been no recall of the drug. Avastin continues to be available on the market as a treatment drug for other cancers, and therefore, doctors can still prescribe it off-label to patients with breast cancer as well as a number of different eye diseases and conditions.
Avastin Silicon Floaters and Contamination in the Eye
Avastin is not approved for the treatment of eye diseases. As a result, doctors repackage the drug into pre-filled syringes to be used in eye injections. These syringes are not always safe to administer any drug into the eye as they may be lubricated with silicone oil.
The problem is that there is a tendency for silicone to migrate away from the syringe and get mixed with Avastin, which is liquid.
In some cases, silicon is injected into the eyes of patients and this results in silicone “floaters” left in the eye – these floaters look like air bubbles in the patient’s eye. Silicon floaters are extremely dangerous as they can lead to serious problems with vision, including blindness.
Silicone-Laced Avastin Eye Injections
Syringes that contain Avastin are frozen by various compounding facilities in order to be shipped. However, this causes the silicone residue on the needle to freeze, thereby becoming a solid. This is why numerous patients have made reports about silicon contamination and silicone floaters after receiving treatment from their doctors.
Floaters are the result of silicone oil pockets and can lead to irreversible damage to the eye. Oil pockets are formed when silicone migrates to the surface of the needle and is inadvertently mixed into the liquid Avastin. The silicon then may be inadvertently injected into the eye of a patient as microdroplets or in the form of a solid.
Regardless of the physical state of the silicone, silicon contamination and silicone floaters in the eye can not only result in visual discomfort, but also increase IOP, or intraocular pressure, which in some cases can lead to corrective ocular surgery.
Apart from those mentioned above, IOP can also cause complications like pain, infection, inflammation, misty or blurred vision, loss of vision, and permanent blindness.
FDA Warnings for Avastin Eye Injections
A safety warning for Avastin was issued in August in the year 2011, by the FDA after 12 people suffering from eye diseases became blind after they were administered with small doses of Avastin by their doctors. As mentioned earlier, Avastin has not been FDA-approved for the treatment of eye diseases.
In March 2013, a recall of Avastin was issued by the FDA and a compounding pharmacy after it was revealed that contaminated lots of the drug were associated with 5 cases of eye infections in patients who were injected with the drug in their eye.
Patients who are already suffering from various eye diseases such as macular degeneration, diabetic macular edema, diabetic retinopathy and retinal vein occlusion and receiving treatment with Avastin eye injections are reporting side effects such as contamination of silicone and silicone floaters in the eye.
The off-label use of Avastin has resulted in a large number of patients suffering from a wide range of side effects and complications. This, in turn, has led to an increase in the number of lawsuits being filed against the manufacturers of the drug as well as compounding pharmacies.
These entities can be sued for failing to inform the public about the dangerous side effects of the drug and the complications that it can cause.
Filing an Avastin Lawsuit
Medications are designed to make you better, not sicker or cause additional health complications. Therefore, it is extremely frustrating when a medication like Avastin does more harm than good and causes side effects that the manufacturing company, the compounding pharmacy or your doctor did not warn you about.
If you are planning to file a lawsuit against any entity for injuries caused by Avastin, you should contact a personal injury attorney who has experience in dealing with large companies and drug injury lawsuits.
You must bear in mind that the process might be a long and arduous one, but it is important to show such companies that they are liable for the harm and injuries you have suffered as a result of their negligence or failure to warn about side effects and complications.
With the help of your attorney, you can hold the manufacturing company or compounding pharmacy liable for the damages you have suffered and file an Avastin lawsuit to recover financial compensation.
There are two types of Avastin lawsuits that you can file – class action suits and individual suits. It is best to file an individual Avastin lawsuit as the process is a little simpler and you are more likely to receive compensation for your injuries, either as a jury award or a settlement from the company.
While class action lawsuits are a great way to seek compensation for many people, they also have disadvantages for those who suffer from far more serious injuries than the average plaintiff. If you or a loved one has suffered severe injury due to an Avastin eye injection or silicone floaters, you should consider filing an individual lawsuit against the party at fault.
Steps to Filing an Avastin Lawsuit
Needless to say, the first thing you need to do to file an Avastin lawsuit is to find a legal counselor with experience in handling cases like yours. Before accepting your case, the attorney will offer a free case evaluation to determine if you have a viable case.
This is an important step as it is when the lawyer learns the details of your case, so you should make sure that you provide all of your important documents to be reviewed.
Once the attorney has evaluated your case, they will determine if you can file a lawsuit against the Avastin manufacturer or compounding pharmacy.
If you have a viable case, your attorney will begin the steps to filing a lawsuit, including filing the necessary documents and motions, bringing in expert witnesses to testify on your behalf, etc. They will get the ball rolling and start the journey to receiving fair compensation for the injuries and harm you have suffered as a result of the drug.
Your legal professional will need to prove that patients are put in unnecessary risk by the off-label treatment of eye conditions using Avastin eye injections that are improperly packaged. In most cases, the compounding pharmacies are at fault as they are involved in the negligent packaging, handling, and shipping of syringes containing Avastin which are intended to be used in eye injection procedures.
These compounding facilities are all over the United States, taking and repackaging the drug in syringes, freezing and shipping them to ophthalmologists all over the country.
The problem is that they do not use proper practices when repackaging Avastin, which in turn puts a large number of patients with different eye diseases and conditions at risk.
Keep in mind that you need to communicate properly with your attorney and make sure that you disclose all the information they need to build a strong case. You need to choose a lawyer that you are comfortable with and can work with as a team.
Make sure that your legal counselor updates you on the progress of your case on a regular basis so that you too have the information you need to know how your lawsuit is going.
Remember that it is important to find the right lawyer to make sure that you have a successful claim and that you receive the financial compensation you deserve for the injuries and hardships you and your family have experienced.
Get Legal Assistance for Avastin Lawsuits
If you or a loved one has been severely injured due to Avastin eye injections, you should seek the help of a skilled and experienced personal injury attorney to help you file an individual Avastin lawsuit against the compounding pharmacy.
An individual lawsuit is a better option as it allows your attorney to focus on helping you seek compensation for the serious injuries you or a loved one has suffered. If the manufacturers of the drug also did not adequately warn your doctor or you about the risks and potential side effects and complications of Avastin, you can file a lawsuit against them too.
If you suffered severely as a result of the side effects or complications brought on by Avastin eye injections, you may qualify for compensation for your injuries, medical costs, pain and suffering, and other damages.
When you have suffered injury or complications due to the failure of a drug manufacturer or compounding pharmacy to warn doctors and patients of the drug’s risks, it is important to make sure that your rights are protected and that you receive financial compensation that you are entitled to by law.
Your personal injury attorney will make sure that you are not taken advantage of by the entities or their insurance companies and will take your case to trial if it is necessary. Don’t sign any paperwork with anyone until you have found legal representation.