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Avastin Eye Inflammation Side Effects Reported in Off-Label Use

  • Written by: AboutLawsuits
  • 22 Comments

The lung and colon cancer drug Avastin has been linked to reports of serious eye inflammation when used off-label to treat wet macular degeneration, a potentially blinding eye condition.

Genentech, Inc., the manufacturer of Avastin, sent a letter on December 19, 2008 to doctors about several recent reports of intraocular inflammatory reactions that occurred after the medication was injected in lower doses to the eye, which is not an approved use of the drug.

As of December 8, 2008, the drug maker indicates that they were aware of 36 reports of adverse events associated with use of the drug to treat eye conditions, and 32 of the events involved severe eye inflammation. These adverse reactions were reported by four different sites in Canada between November 4, 2008 and November 20, 2008.

Avastin (bevacizumab) was approved in 2004 for treatment of non-small cell lung cancer and colorectal cancer when combined with chemotherapy. The drug inhibits tumor growth by preventing the formation of new blood vessels which nourish the tumors.

Although Avastin is not approved for treatment of eye conditions such as wet macular degeneration, doctors are free to use medications “off-label” for purposes that are not approved by the FDA.

Lucentis, which is another drug sold by Genentech in the United States and by Novartis AG in Europe, is structurally and functionally similar to Avastin and is approved to treat the eye condition.

Many doctors have administered Avastin divided into multiple doses as an alternative to Lucentis, which is about 50 times more expensive in comparable doses.

Wet macular degeneration is a potentially blinding eye condition that occurs when new blood vessels start to form under the retina causing hemorrhage, scarring, swelling and central vision loss. Along with the dry type of macular degeneration, the conditions affect over 6 million Americans.

Side effects of Lucentis are known to cause eye inflammation in about 2% of the patients, and it is not clear whether the risk is greater when Avastin is used off label in lower doses.

Of the 32 reports of Avastin eye inflammations disclosed, Genentech indicates that 25 of the events were linked to patients who received the injection from the same lot (B3002B028). However, intravenous use of Avastin has not revealed any unusual reporting patterns associated with this lot and the drug maker indicates that all quality specifications for the lot were met.

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22 comments

  1. Irv Arons Reply

    First, you have a typo in your copy — the letter posted on the Genentech web site stated 36 incidents, not 361 (the 1 referred to a post script).

    Secondly, all of the incidents were related to a single batch of Avastin and it was probably caused either by a bad batch, or mishandling during the compounding into individual doses for administration by ophthalmologists.

    I checked with several retinal specialists and was told it was a one-time event and unlikely to re-occur. With Avastin widely used in the U.S., not one adverse reaction has occurred. All of the incidents reported occurred in Canada.

    For more on this, check out the Pharmalot blog and my comments on that blog.

    link: http://www.pharmalot.com/2008/12/off-label-avastin-use-tied-to-eye-injuries/

    Irv Arons

  2. AboutLawsuits Reply

    CORRECTION: A typographical error in the original posting of this story indicated 361 reported events when the correct number of disclosed events was 36.
    In addition, one instance the article incorrectly referenced eye “infection” when it should have been eye “inflammation.” In all other areas of the post the events were correctly noted as “inflammation” and this has been corrected.

  3. Pingback: Avastin Gastrointestinal Perforation Risk Confirmed by Study - AboutLawsuits.com

  4. Ragini Reply

    My mother (63 yrs) recieved an intravitreal Avastin injection in her right eye as part of her treatment for retinopathy and AMD on 16th July 2009.Her blood pressure and sugar levels were normal at the time of treatment.Within 48 hrs she felt weakness in her right arm and leg ,loss of balance and nausea.An MRI scan revealed she had suffered a stroke .Avastin is not FDA approved for treating eye conditions but is still used ‘off- label’ by many opthalmologists.

  5. Florence Reply

    The Retinal Specialist, Dr. Chang, Sacramento CA, has been treating my right eye wet macular degeneration with the Avastin injection for over a year with no side effects until June 2010 when immediately after the last injection small black rings with yellow litights in the center and new dark floaters appeared to interfere with my vision. She had no explanation nor took responsibility for this. It is now 5 months later and there has been no change in the black rings (Weiss Rings?) or floaters.. I was not informed of any possible dangers with this type of treatment. I have not been seen again for treatment since June. The original distortion – zig zag lines, which almost completely vanished, has not accelerated however. I do not now know how to proceed.

  6. margaret Reply

    can avastin eye injections have a disturbing effect on thyrax medication?

  7. Gail Reply

    Can Avastin injections for macular degeneration affect an older person’s chance of fracturing a hip? Does it affect their bone porosity?

  8. Naomi G Reply

    My mother experienced an episode of Congestive Heart Failure within several days of an injection of Avastin in her right eye, which was used to treat Retinal Vein Occlusion. We cannot get the Retinologist to admit there could be an association, as they believe this side effect can ONLY manifest with Cancer treatment. So her side effect was never reported to the FDA. I wonder how many other side effects have never been reported because the physician is afraid of legal ramifications if they admit they injected a drug that is not FDA approved for treating eye conditions.

  9. Simone M Reply

    i had avastin injection in my right eye after a retinal branch occulsion caused from from high blood pressure.
    after getting the bp under control and was regulated at 117/75 for several months, i got the first injection of avastin. my blood pressure went sky high, my blood sugar went up and i had pain like a knife in my eye for over a week. they said at mayo that the avastin was not to blame, but it all points to that if you ask me seeing as all was under control for months before i got the injection and i did not have blood sugar probs at all till i got the injection. ever since the injection, i have eye pain. and my eye gets dry.

  10. Sarah V Reply

    I’ve had 2 Avastin injection so far in my right eye to treat diabetic macular edema. After my second shot, I had a noticeable increase in blurriness in vision. However I have unexpectantly developed Shingles as well (Herpes Zoster/Chickenpox virus). It is commonly believed that shingles can develop in response to lowered immunity as well as stress. Could the Avastin has lowered my immunity & caused the shingles to occur? I really don’t know what to think & am reluctant to have another shot of Avastin. I would appreciate any reply.

  11. John Reply

    I have undergone a series of three inter ocular injections of Avastin and have suffering moderate to severe continuing headaches for three months.

    The physicians involved have assured me that the treatment is not the cause of the headaches and suggested I had an allergy.

    I have never had an allergy and seldom headaches of any kind.

    Any corroborating information would be greatly appreciated.

  12. MARION Reply

    i have been getting avastin injections for over a year…it has worked very well…my eye site is much better..i recently had an emergency stent put in for a blockage in my heart…i forget to tell the dr. i take avastin and i am worred i wont be able to take the shots for quite awhile..i didnt get to tell this dr. about the shots so he used a stent that requires taking plavix for at least one year…has anyone heard anything about this?

  13. Jin BM Reply

    My friend was diagnosed with wet AMD in July ’11. I took her to the doctor when she found her vision was getting worse by the day. She had been diagnosed with dry AMD some years back (I have a mild case in one eye myself) and I had afeeling the news wouldn’t be good. So I said: “relax, at least the wet AMD is treatable”. She had her first Avastin injection in her L eye about a week later, and her L eye improved slightly. She has had a total of 5 Avastin injections (3R, 2L) since she started treatment. Her left eye vision improved slightly as I said, but her right eye vision DROPPED THROUGH THE FLOOR. It went from being her BETTER eye to being loaded with “shape-changers” “boarder-benders” AND giving her a constant (and most unwanted) continual light show – even when her eye is closed. And not surprisingly occasional nausea due to all the changes. The bulk of these changes happened IMMEDIATELY AFTER THE 1ST INJECTION IN HER R EYE. We understand that a lot of people will tell us that “these are the symptoms of the disease” but the timing is, in our opinion, beyond the realm of coincidence. Her L eye does not have, nor ever had any of the symptoms above. We’re looking for lawyers and we are looking for medical answers.

  14. phillip Reply

    i am wondering if there any fake avastin chemo drugs sold from oct thru dec 2008. my was giving avastin for treatment for brain cancer.she suffered serious side efects before her death on jan 20 2009

  15. Everett Reply

    In the past year I’ve allowed two avastin shots in my right eye. The first was without incident however the Dr. said another was needed. The second one did go as smoothly and since then I have been seeing many more floaters in that eye.
    My insurance company has approved another one of these procedures but I’m continuing to do research on this drug. Also, it seems strange that I am asked to sign a contract not to sue if anything goes wrong. I realize it can easily be broken if necessary, but it seemingly shows a basic lack of confidence.

  16. Julia Reply

    Jin in reply to your comments, I understand your concern. I have had a very similar experience to your friend with exactly the same outcome. I have a disease similar to wet AMD. The injections have worked well in one eye only leaving the other with sight loss, floaters and flashes of light. This was also rapid onset, I have had maybe 4 injections in the right and 3 in the left. I am practically blind in one eye. I am lucky enough to have spoken to a number of consultants over the years about my eye condition in Japan, USA and the UK and although I cannot comment on the safety of the drug used, I can tell you confidently that the floaters and the flashes of light are a symptom of eye disease. The flashes could be caused by a detached retina but most likely the problems are caused by PVD which happens as the eye ages or in diseased eyes. Sometimes the changes in our sight can be very upsetting and frightening since we are not warned by our doctors in advance what to expect. Having also spoken to other people with diseased eyes who have not had any injections I can confirm that they also suffer from flashes and from floaters. However unless your friend properly investigates the reason behind the problems in her eye we can only
    speculate. I think if the injection has caused her to lose sight in that eye, it would be from infection, if there was an infection from the injection she would have experienced prolonged pain and inflammation at the time of the injection. I hope she gets some answers personally i think it is best not to expect miracles from the drug, sometimes it works better in one eye because the extent of the disease is greater in one eye.

  17. John Reply

    My wife has just received her seventh intraocular injection of Avastin. Since she started this treatment she has begun to have heartburn and was treating it with Tums. In the past six weeks this has become so severe that it has required medical intervention, but no one has in any way connected it to he Avastin injections. Although this drug when used for intraocular injection is in tiny doses, it is not inconceivable that it would be absorbed and in susceptible individuals coould cause severe gastrointestinal symptoms. The ophthalmologists never ask any questions about other that eye symptoms. Have any of those other people receiving such injections had similar experieinces of systemic disorders?

  18. Karen Reply

    Actually there has been an incidence of isolated 6th nerve palsy from an injection. I had the injections and had the exact same symptoms as was outlined in the study, including severe eye pain, nystagmus, diplopia and redness. I also lost several lines of vision, have photosensitivity, and blurred vision in the eye that was injected.
    Karen

  19. Joe Reply

    I got a shot of Avastin in my right eye this past December. My vision in that eye prior to the injection was 20/25. Today it\\\\\\\\\\\\\\\’s 20/2000. That shot burned really bad and caused cellulites in the eye. My vision rapidly deteriorated right after that shot. The next thing you know, I end up getting sent to Vanderbilt hospital. Was out of work for eight months.

  20. Adrianne Reply

    I have had similar experience with severe heartburn developing after having had 12 injections in my right eye of Avastin (every 6 weeks since May 2012 for retinal vein occlusion. The heartburn and weight loss doesn’t seem to have any other explanation as I have not had this before this series of injections and there was no dietary or lifestyle changes that could account for relatively sudden onset of this severe heartburn problem. Retinal specialist says dose is so tiny it couldn’t have that effect but I agree that it makes sense that absorption could occur over time. I can’t think of any other explanation. I’ve even been given endoscopy and results were normal. Very worrisome.

  21. Marie Reply

    Received Avastin shot in left eye on 7/10/15. Have been experiencing pain in the left side of my head intermittently. Could this be cause for concern?

  22. Melissa Reply

    I have had my first shot of this medicine in my left eye to treat severe diabetic retinopathy and have headaches around my left eye for a week now! I have to go back tomorrow to get my right eye done and I’m dreading it. Then I have to get injections every 5 weeks for up to 5 years! I can’t believe that there’s no way to treat my condition that is less intrusive and painful!!! My retinal specialist is an unsympathetic jerk which makes the experience even worse! It truly sucks to be diabetic!!! I loathe these treatments and feel like a lab rat! I’m more concerned knowing now that this drug isn’t even approved for retinopathy treatment!!!

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