Alarming New Studies Link Elmiron® To Serious Eye Disease...
What Elmiron® Patients Must Know About the Frightening New Research Linking This Popular Interstitial Cystitis (ie. Painful Bladder) Drug To Serious Eye Disease
From the desk of:
Andy Bederman, Managing Attorney
To Elmiron® Users:
If you have ever taken prescription Elmiron® (aka. pentosan polysulfate sodium, or PPS), this may be the most important message you will ever read...
Here is why...
Recent research has linked popular interstitial cystitis (aka. painful bladder syndrome) drug, Elmiron®, with a unique form of progressive eye disease -- typically diagnosed by ophthalmologists as retinal maculopathy, retinal pigmentary endothelium injury (RPE), or age-related macular degeneration.
Common symptoms for patients experiencing this Elmiron®-associated eye damage are:
- Difficulty reading
- Difficulty adapting to dim lighting
- Blurred vision (often centrally in the patient's field of vision)
- Dark spots in center of vision
- Straight lines appearing curved or squiggly
- Muted, less vivid colors
If you have ever taken Elmiron®, it is important for you to understand the following information. So please continue reading as the following information is critical to your health...
Emory Eye Center in Atlanta Discovers Entirely New Eye Disease In Six Female Patients -- All Found To Be Taking Elmiron®...
From 2015 to 2018, The Emory Eye Center in Atlanta, GA began seeing something they've never seen before...
Ophthalmologists witnessed an entirely new eye disease in 6 of their patients — found through the use of advanced retinal imaging.
This new, never before seen eye disease was classified as a "retinal maculopathy" — meaning the pigment cells within the eye's retina literally change color.
This change in color causes significant vision and eye dysfunction, similar to the effects seen in patients with age-related macular degeneration.
In fact, Emory's doctors say that this new disease is so similar in appearance to macular degeneration, that most patients who have it would probably get diagnosed with macular degeneration or pattern dystrophy.
Strangely, All Six of the Patients With This Unique Eye Disease Were Women...
All six of the patients with this never before seen "retinal maculopathy" just so happened to be female.
Due to the seriousness of this unique eye disease, and the need to understand what was causing this in six of their female patients, Emory Eye Center conducted an on-going "case series" research study with these 6 patients.
Emory's goal — to determine what was causing this new and disturbing retinal pigmentary maculopathy.
The Study Discovered That All Six Female Patients Were Taking Elmiron® For Interstitial Cystitis
After an exhaustive review of each patient's medical history, the researchers were able to find a clear and convincing commonality...
All six patients had been previously diagnosed with interstitial cystitis (painful bladder syndrome) and were currently taking the prescription drug, Elmiron® — a common first-line therapy prescribed by urologists to patients who suffer from painful bladder.
Elmiron® (aka. pentosan polysulfate sodium, or PPS) was first approved for use for bladder pain in 1996 and is an oral medication (pill).
Thought to provide a "bladder coating effect" to patients, it works by adding an extra coating of protection to the inner bladder walls — helping to mitigate bladder irritation and discomfort.
While the typical dose prescribed by urologists is 300mg per day (usually in 100mg doses taken three times per day), it is not uncommon for patients with severe symptoms to be prescribed daily doses of 1,000mg to 1,500mg per day.
Emory Publishes The Results of Their Disturbing Findings In The Journal of Ophthalmology in May 2018...
After the researchers at Emory Eye Center ruled out any genetic pre-disposition to retinal maculopathy in the six patients (which they did through proper DNA testing), Emory published the disturbing findings in the Journal of Ophthalmology in May of 2018.
For over 20 years, Elmiron® has been taken by millions of patients worldwide. Many patients have been taking it every day since it was brought to market in 1996...
During that time, no one had ever put the pieces together that a bladder drug prescribed by urologists would be the cause of devastating damage to the eyes.
The presentation of this Elmiron®-associated retinal maculopathy is so very similar to age-related macular degeneration and macular/pattern dystrophy that it's highly likely that ophthalmologists have been wrongfully diagnosing it as such — missing that it's actually a unique retinal injury caused by some unknown mechanism with oral Elmiron®.
In fact, many Elmiron® patients may not even know they have this macular disorder, and instead just assume their vision is degrading (getting blurry, harder to see at night, etc).
Medical Community Turned Upside Down By Frightening Elmiron® Discovery — More Studies and Research Begins...
When Emory Eye Center released their findings, it set off a firestorm of worries and new questions that needed answered...
Since Emory's case series consisted of only 6 patients — there wasn't enough data to understand what approximate percentage of people who take (or have taken) Elmiron® may be affected by these eye and vision problems.
In other words, new "population-based" studies were needed to know if this was a "common" or "uncommon" side effect of Elmiron®. Does it happen to everyone or just a small, unfortunate few?
And how long would a patient need to take Elmiron® before such eye damage could occur?
Is the eye injury dependent on dosage amount?
Does a high dose increase the chances of retinal injury compared to lower dose?
Would the progression of eye damage stop after discontinuing use of Elmiron®?
If an affected patient stopped using Elmiron®, would the eye injuries stay the same, reverse entirely, or worse, continue to progress despite stopping use?
These were the questions that needed answers — so new research and studies were immediately put into action.
Doctors At Kaiser In Oakland See Emory's Study in the Journal of Ophthalmology — Find Elmiron® Patients In Their Database And Ask Them To Come In For Eye Examination...
Shortly after seeing the groundbreaking Emory Eye Center article in the Journal of Ophthalmology, Kaiser Oakland immediately began searching for patients in their database who had been prescribed Elmiron® for interstitial cystitis or bladder pain.
Kaiser found 140 patients in their database currently taking Elmiron® that had been consistently using it for 5 years or more.
All 140 patients were contacted and invited to come and get a full eye examination using the advanced retinal imaging Emory Eye Center had used to discover the Elmiron®-associated maculopathy.
Of the 140 contacted, 91 agreed to come and get their eyes examined.
Kaiser Found Serious Retinal Maculopathy in 22 of the 91 Elmiron® Users
Twenty-four percent (24%) of the Elmiron® users that Kaiser Oakland examined had the exact Elmiron®-associated retinal maculopathy and pigmentary damage that was presented in the original Emory Eye Center study.
22 of the 91 patients not only had significant damage to their retina, but they also reported significant eye and vision problems as a result.
Difficulty Reading, Difficulty Adapting to Dim Lighting, Blurred Vision or Dark Spots in Center of View -- And Many More Side Effects...
Those patients Kaiser Oakland found to have Elmiron®-associated retinal maculopathy reported many vision-related symptoms, including:
- Difficulty reading
- Difficulty adapting to dim lighting
- Blurred vision (often centrally in the patient's field of vision)
- Dark spots in center of vision
- Straight lines appearing curved or squiggly
- Less vivid colors
Below is an animated simulation showing some of the vision-related problems that have been linked to Elmiron®:
Interstitial Cystitis Network Performs Survey of Their Members Who Take Elmiron® — Alarming 53.9% of Elmiron® Users Reported They Have Developed Retinal Disease...
One of the largest advocacy groups for interstitial cystitis patients, the IC Network, conducted a survey of its members who take prescription Elmiron®...
The results, thus far, are frightening...
In the IC Network's last public report of the Elmiron® eye damage survey, the organization's founder, Jill Osborne reported that of 1,604 patients in the survey who take Elmiron®, 53.87% have reported that they have developed retinal disease.
That means more than half of the patients on Elmiron® in their survey have experienced retinal disease.
IC Network Delivers Frightening Survey Results to FDA -- Includes Petition Seeking New Warnings Be Added To Elmiron®
After quickly seeing the alarming numbers of Elmiron® patients being affected by retinal damage, the IC Network took quick action to advocate for interstitial cystitis patients by sending it's survey data to the FDA.
The IC Network also delivered to the FDA a petition seeking changes to Elmiron®'s warnings label — recommending that interstitial cystitis patients who take Elmiron® should at the very least be monitored by an ophthalmologist once per year to determine if retinal maculopathy has resulted.
Harvard Medical School Ophthalmologist: Maculopathy In Patients Could Progress Even After Full Discontinuation of Elmiron®!
Dr. Rachel M. Huckfeldt, an ophthalmologist that specializes in retinal degenerations at Harvard Medical School, published one of the most concerning case reports regarding the dangers of Elmiron®...
In October 2019, Dr. Huckfeldt published a case report in the Journal Ophthalmic Surgery Lasers and Imaging Retina chronicling the story of a female eye patient she had treated over the course of an 8 year period.
This female patient originally came to Dr. Huckfeldt (Year 1) complaining of blurry vision and difficulty seeing at night and in dark environments that had started the year prior.
In an attempt to rule out genetic pre-disposition to retinal disease, Dr. Huckfeldt and her team conducted extensive DNA testing to determine if the retinal maculopathy of this patient was genetically inherited.
No genetic inheritance was found. No family history. It was something else causing the maculopathy...
Same Female Patient Returns to Dr. Huckfeldt Six Years Later (Year 6) -- With Even Worse Vision...
Six years later (Year 6), this same patient returns to Dr. Huckfeldt stating her vision has degraded substantially more.
New images of her eye were performed and it was obvious that this patient had a significant worsening of retinal damage and maculopathy since her first visit 6 years ago (Year 1).
With no clear explanation as to what was causing this patient's retinal disease, Dr. Huckfeldt was left to assume that what she was seeing in this patient was "toxic retinopathy" — meaning the patient must have been exposed to some toxin that was damaging her eyes.
The patient was not aware of any toxic exposure that could have caused this — so the mystery of what was causing the retinal damage remained...
Female Patient Returns AGAIN At Year 8 — Her Vision Continues To Seriously Degrade...
Two years later (Year 8) the same female patient returns again to Dr. Huckfeldt with signs that her retinal damage has continued to substantially degrade.
Again, the patient knows of no known toxic exposure and the doctors are unsure what is causing the disease.
IMPORTANT TO UNDERSTAND: At this point in time, Elmiron® had not yet been linked to retinal maculopathy or vision problems. The studies and research in journals had not yet been published reporting the dangers of Elmiron®-associated retinal maculopathy.
But the pivotal moment for Dr. Huckfeldt and her female patient came in May 2018 when Dr. Huckfeldt saw the article published in the Journal of Ophthalmology by the doctors at Emory Eye Center.
Dr. Huckfeldt Reads Emory's Journal Article About Elmiron® — Immediately Remembers Unique Female Patient With Similar Retinal Damage As Shown In Article...
Immediately, Dr. Huckfeldt remembered her female patient as having a similar type of retinal damage and wondered if her patient, like the patients shown in the journal article, had ever taken Elmiron®...
Dr. Huckfeldt went back into her patient's records and found that she had been diagnosed by a urologist with interstitial cystitis and had been prescribed daily 200mg low-dose Elmiron®.
Immediately, Dr. Huckfeldt had to assume that this patient has been taking Elmiron® the whole time, and that could be the reason why her retinal maculopathy has continued to get worse and worse each year.
So she reached out to her female patient and asked her to come in for an appointment. Dr. Huckfeldt was going to share the new research with the patient and hopefully the patient could discontinue Elmiron® in hopes to stop the progression of eye damage and vision loss...
Female Patient to Dr. Huckfeldt: "But I stopped taking Elmiron® years ago..."
Unfortunately, this is where a sad story turned even worse...
Dr. Huckfeldt told the female patient that new research has now linked Elmiron® with the progressive eye disease she suffers from. And that her continued use of Elmiron® was likely the cause of her progressive retinal damage and worsening vision.
But, to the horror of the medical community today, the patient explained that she had stopped using Elmiron® many years ago (on her own).
Now remember... this patient had seen Dr. Huckfeldt for her progressive retinal disease for 8 years...
The patient explained she had discontinued taking Elmiron® at (Year 2) — which meant that this patient's retina and vision continued to worsen and degrade EVEN AFTER stopping use of Elmiron®.
Often when a prescription drug is found to be causing a side effect, discontinuing use can often reverse, or at worse, stop the progression of that side effect.
But in this case, none of that seemed to be true.
Dr. Huckfeldt's patient continued to see substantial progression of retinal damage and vision loss even after full discontinuation of Elmiron® use.
Even If You Quit Elmiron®, The Progression of Eye Disease Continues To Worsen...
This news shook the medical community...
Dr. Huckfeldt decided to publish her case study of this one patient, explaining that even after discontinuing Elmiron®, her patient's vision and condition continued to degrade.
All of which brings up another key question that remains unanswered...
Are patients who used to take Elmiron®, but no longer take it, still at risk for retinal maculopathy?
If you quit Elmiron® and your ophthalmologist later on says your eyes look perfectly normal, are you in the clear? Or could there be a delay in the onset of retinal damage?
Sadly, no one really knows yet, but nearly everyone in the medical community agrees that if you ever took Elmiron®, you should see an ophthalmologist and have your eyes examined — and probably on a regular, on-going basis.
If You Have Ever Taken Elmiron®, You Should Get Your Eyes Examined By An Ophthalmologist -- With These Recommended Tests...
The medical community is in agreement that Elmiron® users, both past and present, should see an ophthalmologist to check for Elmiron®-associated retinal maculopathy.
It's important that Elmiron® patients seek a comprehensive examination from an ophthalmologist, not an optometrist... as an optometrist is more for evaluating your vision for wearing glasses. An ophthalmologist can perform the necessary exams to determine your retinal health as it relates to Elmiron®-associated eye disease.
Get Our Free Printable PDF On The Latest Elmiron® Eye Disease Research To Share With Your Doctors — As They May Not Be Aware of These Developments
We have put together a friendly and easy-to-understand PDF guide that you can share with your urologist, primary care provider and ophthalmologist that explains the latest research and discoveries pertaining to Elmiron®-associated retinal maculopathy.
The free PDF guide has summaries of the studies and research published in the medical journals, along with links to the research online that doctors can visit if they would like to read the research and medical journals to become more familiar with the significance of these findings and how it may affect you or your loved one.
Also in the PDF guide, we outline the tests and medical imaging exams ophthalmologists are recommending Elmiron® patients ask for.
Simply enter your email address below to receive the free PDF guide instantly — and we will also be providing email updates to everyone as new studies and research emerges on Elmiron® into the future.
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And again, as new research and recommendations come forth from the medical community, we will be updating our guide and sharing news via email — so it will be of value to current and past Elmiron® users.
What To Do If You Have Taken (or Currently Take) Elmiron® -- and Your Vision and Eye Exams Are Normal...
Unfortunately, the medical community does not yet understand how Elmiron® is causing damage to the eyes — the mechanism which causes eye injury is still unknown.
Some scientists are speculating that there may be a mechanism within Elmiron® that switches certain gene expressions within the DNA that suddenly create a pre-disposition to progressive retinal maculopathy — but it's all speculation at this point.
So if you have taken Elmiron® in the past, or are currently taking Elmiron®, and a recent ophthalmology exam found your eyes to be normal, that does not necessarily mean that you haven't been affected by Elmiron®. This is because doctors are unsure if there is a delay in symptoms to present themselves.
So regardless, it is still advised to speak with your doctors and stay up on the latest research that will be coming out about Elmiron®-associated eye disease.
The Manufacturer of Elmiron® Knew Back In The 90's That Elmiron® Could Cause Serious Eye Injuries — But Never Listed Them On The Drug's Warning Label...
When Emory Eye Center of Atlanta first discovered the Elmiron®-associated retinal maculopathy in their 6 patients, before publishing their case series to The Journal of Ophthalmology, they looked back at all the early clinical trials of Elmiron® that were performed by the manufacturer.
Emory's researchers found that in an unmasked clinical trial of 2,499 patients who took Elmiron® for up to four years, both vision and eye related adverse events were indeed reported.
The manufacturer of Elmiron® knew that patients in the drug's clinical trials were found to develop optic neuritis and retinal hemorrhage — but no where on the drug's warning label are these listed.
And no further tests or research were done to explore if there was indeed a mechanism of Elmiron® that could cause such serious eye disorders.
It was simply, ignored.
Amidst An Avalanche of Studies Showing A Link Between Elmiron® and Eye Disease — The Manufacturer (Janssen Pharmaceuticals) Has Been Silent...
Many times when brand new side effects are discovered AFTER a drug has already been on the market, the pharmaceutical company that manufactures the drug will take certain actions...
Some common actions are to, 1) acknowledge a concern for the new findings and commit to further study the drug's link to the side effect, 2) update the drug's warnings to reflect the new research and finding, or 3) voluntarily withdraw the drug from the market until they can better understand the mechanism causing the side effects and the real risk being posed to patients.
So far, it appears that none of the above actions have been taken by Janssen Pharmaceuticals, maker of Elmiron®.
It's perfectly clear to so many in the medical community that Elmiron® is linked to a substantial risk for serious eye injury, and even blindness...
So why is Janssen Pharmaceuticals silent? Why haven't they at least updated the drug's label to reflect new warnings of eye disease?
If You Ever Took (or Currently Take) Elmiron®, Now Is The Time To Start Documenting Your Eye's Health...
If you took Elmiron®, currently or in the past, you really owe it to yourself to see an ophthalmologist and begin documenting (probably annually) the health of your eyes — particularly your retinas.
You need to establish a baseline as soon as possible, if you haven't already. That way you can monitor any progression of eye disease that may occur later on down the line.
Additionally, if the worst was to happen and you began developing signs of maculopathy, you would have records of when it developed and if the presentation of that maculopathy is of the nature presented in the recent research.
"If you have damage, you need to start documenting that damage over time. You want to save everything, you want to have these tests every year, so that you can show the physical damage is happening so you can make a case for your place in any class action lawsuit or any mass tort lawsuit. So this is not the time to hide from the doctor. This is the time to go to the doctor and start developing some data."-- Jill Osborne, President of Interstitial Cystitis Network
When Drug Manufacturers Fail To Properly Warn of Dangers, Innocent Patients Become Victims
As a result of the manufacturer of Elmiron® failing to properly warn patients and doctors of these eye disease risks, you or your loved, along with their doctor, never had the ability to truly make an informed decision as to whether Elmiron®'s potential benefits was worth the associated risks.
Patients and doctors have a right to "informed consent" -- You have the right to know your treatment options and take part in the decisions about your care.
Many patients don't realize that there is something called a "Patient Bill of Rights" in the US, and that the FDA has strict rules for pharmaceuticals to disclose all known side effects of its drug.
Why should you suffer and be responsible for serious vision problems or eye disease caused by a drug manufacturer's failure to properly warn of such risks to both doctors and patients?
As a victim of a drug that potentially failed to properly warn you of such eye damage risks with their medication, you may be entitled to what are called "money damages", which is just a legal term for money awarded from individual lawsuits, class action lawsuits and settlements.
All potential Elmiron® lawsuits are currently being investigated on the grounds that Janssen Pharmaceuticals® (maker of Elmiron®)...
- failed to properly warn patients and doctors of known eye-related injury risks
How To Pursue Financial Compensation If You (Or A Loved One) Was Affected...
Our legal team has reviewed the available evidence and our experience tells us that we are in prime position to represent victims who may have suffered vision complications or eye disease due to Elmiron® use.
We are currently accepting cases nationally from all 50 states.
Get A Free Legal Consultation With Our Elmiron® Lawyers Today
For a limited time, our Elmiron® lawsuit lawyers are offering FREE legal consultations.
This is your opportunity to have a conversation with an experienced attorney who can answer all your questions and help you determine if you are eligible to pursue financial compensation.
Act Now Because There Is A Limited Window of Time To Pursue A Legal Case
There is a very small window of time for victims to seek financial compensation after an injury -- it is called the "statute of limitations" and the time window for pursuing a case is different in each state.
So please do not wait to speak to an attorney because you do not want to miss your opportunity to pursue an Elmiron® settlement or lawsuit.
Here is how to get started:
Fill out the free consultation form below and one of our attorneys will promptly call you to discuss your case.
This consultation is FREE. There is no-risk and no obligation. This is simply your opportunity to understand if you have a case and discover what your legal options are in terms of pursuing financial compensation.
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