Me too.
What does it take to qualify for Medicare through disability? IS it being legally blind?
Does anyone know why eye injection Lucentis is on the medical dangerous drug list?
one of the Side effect :
Luncentia- causes strokes
My eye doctor has been injecting this stuff in my eye for 8 months now. This information has scared me. I want to see but I do not want to get a stroke.
missrobie,
I have also been getting Lucentis injections. Genentech, the drug manufacturer sends me copies of the possible side effects and adverse reaction caused by the drug which include "serious, sometimes fatal, problems related to blood clots, such as heart attacks and strokes." Other possible side effect include inflammation, increased pressure, cataracts, nose and throat infections, anemia, and nausea. The information that I receive from Genetech is similar to the package inserts that I get from my pharmacy for other prescription medications that I use.
I believe that the side effects are caused by the fact that Lucendis is a very potent drug, and like all prescription medications, it has ingredients which may occasionally cause serious problems.
I know that it took a long time for the FDA to approve of its use in controlling Macula Edema which is an indication that this is a very serious drug. I realize that the drug does involve risks, BUT not taking the drug caused blindness. I love being able to see. Everyday, I look at the sky, the colors and beauty around me. I read and watch tv. I remember being unable to ride on a subway without being terrified.
Unfortunately, I have needed repeated injections and I do get flareups. But between treatments, I am very happy with the results.
If you want to read about the side effects, you can get the information on the internet, just search for "Lucendi."
I was actually happy that you have access to these injections. I thought the reason that you were complaining about working conditions was that you couldn't afford to have treatment.
amanda02 ,
I want to see but I do not want to have a stroke either. What good is seeing if you're going to die or have complication from a stroke. the reason why I brought this up. There is a Lucentis class action suit
missrobbie,
I can understand that would be frightening, but as I wrote, ALL prescription meds have side effects, so you have to make a decision about which matters most to you and whether your doctor thinks the benefits outweigh the risks. From what I read, the actual risk is small, and I think the benefit is important. When I saw my retina specialist a couple of weeks ago, he did tell me that I needed to watch my lipids. I also know that blood pressure is also important, and people who have had strokes are at higher risk.
amanda02 ,
My eye doctor never discuss Lucentis side effect with me,that's why i'm upset. He and his staff just told me to sign these forms while my eyes were dilated . I'm worried, I have a history of high blood pressure so I am very concern about using these eye injection (Linentis and/or Asatins). I want to see but I do not want to add a stroke or heart complication to my plate. I will be just a stroke victim with go eyesight or a died stroke victim who had good eyesight. I'm going to check out this class action suit for Lunentis.
missrobbie,
Just a few days ago I had to make a similar decision, although it did not concern a diabetes drug. I agree with Amanda, you will eventually have to make your own decision.
Find a friend or a friend of a friend who knows how to both search for and understand scientific literature - the FULL, ORIGINAL publications, not just the short summaries they send to doctors for advertising purposes, and find out whether the degree and probability of expected improvement seems sufficient TO YOU in terms of the probability of stroke involved, TAKING INTO ACCOUNT that you have high blood pressure.
There is a lot of dirt among doctors. I doubt that your doctor could persuade a jury that having you sign a paper while your eyes were dilated, without having explain anything orally first, is "informed consent". In the legal framework where I doubt that your signature would be considered a legal signature at all, since you probably couldn't see what you were signing.
I recently cracked a rib while coughing. After discovering that I have osteoporosis, my GP prescribed alendronate, explaining nothing. I took a quick tour through the literature, and told a friend of a friend, an orthopedist, that I wanted to know two things:
the rate of "atypical fractures of the femur" associated with alendronate and other bisphosphonates, relative to the improvement in the statistics for other fractures, and whether my diabetes made me more prone to osteonecrosis of the jaw, and what this meant in statistical terms. (I explained to him why I thought it might.) He ended up saying that he wouldn't take it in my condition, although the research is unclear and some of his colleagues would disagree.
What got me annoyed that I had to find all of this information, and arrange this discussion, myself; my doctor just barked that I should take it, explaining nothing.
I don't agree with Amanda about "whether your doctor thinks the benefits outweigh the risks." Very few doctors have even seen the original research, and most are incapable of understanding the statistical and scientific questions involved. Maybe missrobbie should find one or more doctors who are able and willing to explain the actual documents to her, so she can make a decision.
Good luck, all
M.
I don't think "informed consent" documents have much of a chance of standing up in court if actual, serious harm can be proven. I think they are mainly used by insurance companies to talk patients into settling, rather than suing.
/oh man, I deleted my old post.
Amaanda)2,
i'm going to halt my Lunentis eye injection until i get some answers about stroke and heart complication being a serious side effect.
@MapleSugar @missrobbie @amanda02 As a retina specialist, perhaps I can lend some perspective.
ATE's stands for Arterial Thromboembolic Events. It includes nonfatal stroke and heart attack.
Lucentis and other anti-VEGF drugs carry the same warnings; there is a risk of ATE after receiving an anti-VEGF medication.
Why? When the FDA is tasked with approving a new drug, paramount concerns are efficacy (how well does the drug work) and safety (how safe is the drug).
Basically, during the Lucentis FDA trials, ATE's occurred, though at a very low rate. The company and FDA are compelled that ATE's occurred.
For example, if a heart attack or stroke occurred while Lucentis was being investigated, the heart attack or stroke needed to be reported to the FDA.
Noone knows if Lucentis causes heart attack or stroke - it simply is noted that during the study, heart attack or stroke did occur.
Is it possible that out of the many patients of diabetics that develop macular edema, some of the people sustain heart attacks or strokes?
The FDA warning only says that heart attack or stroke occurred in their study group at a rate of 1-2%. It does not say that anti-VEGF causes heart attack or stroke.
Hope this was less confusing.
Randy
Thank Randall,
For now, i'm going to halt my Lunentis injection. I've been taking this stuff fro 8 months and I want a rest period.
"The FDA warning only says that heart attack or stroke occurred in their study group at a rate of 1-2%. It does not say that anti-VEGF causes heart attack or stroke."
I'm sorry, but even Genentech doesn't seem to be making that claim, in the "Briefing Book" which they submitted to the FDA to get Lucentis approved.
First of all, the "Briefing Book" on Lucentis is available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DermatologicandOphthalmicDrugsAdvisoryCommittee/UCM313089.pdf (May Heaven preserve us!). Anyone who can should study as much of the book as they find convenient and useful, and not believe me, Dr. Wong, or anyone else as to its contents. They should also study the original research as much as convenient. The Briefing Book is just a VERY partisan summary.
Genentech did not tell the FDA that some people got strokes, heart attacks, etc. Genentech said that more people in the groups treated with Lucentis got strokes, heart attacks, etc. than those in the supposedly matched control groups. See, for example, their Table 16. They also implied (pp. 77-86) that they would have suspected such an association anyway, their own research on intravitreal RZB suggested adverse effects "historically associated with systemic VEGF inhibition", including "arterial thromboembolic events". (The words in quotes are indeed all theirs.)
From their paragraph 10.2, p. 94: "In RIDE and RISE, ranibizumab
treatment resulted in known anti-VEGF-related and procedure-related adverse events
and was generally well-tolerated by patients with DME."
From the end of 10.2, p. 95: "Events potentially related to systemic VEGF inhibition, including thromboembolic
events (such as myocardial infarction or stroke), hypertension, non-ocular
hemorrhage, wound healing complications, and others; some of these events can
be serious and may be fatal."
Again: "Trends toward increased [emphasis added] incidence of arteriothromboembolic events (ATEs), mainly
stroke, have been observed in some prior studies of ranibizumab in neovascular AMD,..."
Good luck,
M.
MapleSugar,
First we have to keep in mind, the drug company and medical field is making money off of Lucentis but anyway, this debate remind me of HRT menopause drug side effect
This quote I found on the bad drug website
"
"As of January 2007, there has been a confirmed stroke risk associated with patients taking Lucentis."
For me and for now I am going to halt my Lucebtis injection. I have a history of hypertension. I could be in that 1-2% group. I want to see but I don't want to further put myself in stroke danger.
Dr. Wong, Thanks for stepping in! It is always kind of you to provide us with a professional opinion in this forum. Your explanation is clear and helpful
MapleSugar, Thanks for your research. I will look at it when I have the time
Personally, I am very grateful that Lucendis is available despite whatever downsides there may be.
When I first went to see a retina specialist, I was told that I was legally blind. To me, that was a very frightening period. My father had been blind. A friend of mine had slowly lost her eyesight due to Macula Degeneration and spent the remainder of her life in a nursing home.
I'm assuming that most of you are receiving Lucentis because of diabetic macular edema?
There is another treatment for DME, called Ozurdex. It is a sustained release intraocular steroid and is very effective. It has been FDA approved for about 4 years, but for retinal vascular occlusions. It is now approved for diabetic macular edema.
I love it for my patients - the steroid is not a new drug and has been around for generations (dexamethasone), the safety profile is great (no record of ATE's!) and significantly cuts down on office visits and injections - it lasts about 4 months.
Ask your retina specialist.
amanda02 ,
Like I said , this debate probably will be like HRT/menopause drug side effect. HRT has ALLOT of bad side effect for women but some women are willing to take the risk just to replace hormones and symptom relief . For me and for now ,I am going to halt Lucendis injection. I want to see but I do not want to take the small or big stroke risk. I have a history of hypertension. My dad went in the hospital for mini stroke last Oct. I had to feed my dad, help him go to the bathroom, dress him ,help him learn how to talk and memory lost. Yes I would like to see but I do not want an added stroke risk 1-2% change right now.
I think Dr Wong for his comments but there are 3 sides to this Lucendis side effect debate good, bad and the truth.
Dr wong ,
What is the deal with steroid in eye injection?
Dr. Wong, My retina specialist did mention Ozurdex to me last year, but was waiting for FDA approval. I will ask him about it again when I see him next month!
missrobbie, I never used used HRT, and I am very glad I did not, just as I am very glad I never used Fosimax for bone density. I agree that sometimes the potential benefit of drugs is outweighed by possible harm.