- 1 Meet The Lawyer Filing Elmiron Lawsuits
- 2 Helpful Resources
- 3 Overview
- 4 Reports of Elmiron Eye Damage Side Effects From Medical Journals, Universities, and Government Agencies (Timeline)
- 5 What is the Elmiron lawsuit all about? Maculopathy.
- 6 Tips if you suspect Elmiron has caused eye problems. Talk with Doctor.
- 7 Free Downloadable Guide – Give This to Your Doctor
- 8 Elmiron Lawsuits Filed Against Janssen Pharmaceutical For Elmiron Associated Retinal Maculopathy
- 9 Elmiron Class Action Lawsuit (Now Filed)
- 10 Do You Have an Elmiron Lawsuit? Contact a Lawyer Today.
If you took Elmiron and were diagnosed with Elmiron induced eye damage including pigmentary maculopathy, atypical retinopathy, blindness or other ocular side effects, you should consider speaking with a lawyer and filing Elmiron lawsuits against the manufacturer.
Can Elmiron cause blindness or other eye problems? Yes. Elmiron has been linked to some very severe eye problems that can cause vision impairment, eye damage, retina problems, macular degeneration, eye disease, ocular side effects, maculopathy, and even blindness.
Meet The Lawyer Filing Elmiron LawsuitsWe reached out to the lawyer filing these lawsuits to learn more about the litigation.
Helpful ResourcesIf you have questions about Elmiron associated vision loss or about the Elmiron lawsuit, click the following links. The PDFs contained in them provide valuable information.
- Elmiron Litigation Guide
- Give This to Your Doctor – Free Downloadable PDF Guide
- The IC Network – If you suffer from Interstitial Cystitis, you should join a free support group. The IC Network is wonderful and provides a wealth of information on their website, has a support forum, and does Facebook Live videos on a regular basis.
Have you suffered side effects after taking Elmiron? Have you been diagnosed with pigmentary maculopathy or do you suspect that Elmiron has caused eye damage or some other sort of eye problems? If so, you should contact. If so, you may be entitled to financial compensation by filing a lawsuit. For a free, no-obligation review of your potential case and to contact attorney Timothy Becker at Johnson // Becker, PLLC.
The manufacturer of Elmiron (pronounced EL ma ron), Janssen Pharmaceuticals, Inc., states on their website, “It is not known exactly how ELMIRON® works, but it is not a pain medication like aspirin or acetaminophen.”
Being that over 1 million people in the United States, mostly women, are estimated to experience bladder or pelvic region pain, and Elmiron is the only known treatment on the market, we estimate that hundreds of thousands of people have been exposed to the drug.
Reports of Elmiron Eye Damage Side Effects From Medical Journals, Universities, and Government Agencies (Timeline)
- In 2018, an article was published in the American Academy of Ophthalmology (AAO) that outlined how a number of people experienced pigmentary maculopathy after being exposed to Elmiron. Between the years 2015 and 2017, six patients were treated for these eye problems at the Emory Eye Center in Georgia. By 2019, the number went up to ten people.
- In 2019 the AAO published another report titled, “More Evidence Linking Common Bladder Medication to a Vision-threatening Eye Condition“, where scientists at Kaiser Permanente found that about one-quarter of patients with significant exposure to Elmiron showed definite signs of eye damage and that this medication toxicity could masquerade as other known retinal conditions, such as age-related macular degeneration or pattern dystrophy.
- In 2020, researchers at the Emory Eye Center (Emory School of Medicine, Atlanta, GA) documented cases of retinal maculopathy (aka retinal injury) in some IC patients who used Elmiron for long periods of time.
- January 30, 2020 – The European Medicines Agency (the EU equivalent of the U.S. Food & Drug Administration) released a paper titled, “SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)“. The Agency sought medical expert opinions on the potential risk for developing pigmentary maculopathy and, based on their findings, they issued guidance with regard to the need for periodic eye examination(s) of Elmiron patients. Here are their findings:
- All patients should have an ophthalmologic examination after 6 months of use of Elmiron, at the same time of the regular reassessment of response to treatment with Elmiron.
- If the examination reveals no pathologic findings, the next ophthalmologic examination should be performed regularly at 5 years of Elmiron treatment (or earlier, in case of visual complaints). However, in case of pathologic findings, the ophthalmological examinations should be performed every year.
- May 2020 – The American College of Obstetricians and Gynecologists publishes a well known medical journal called, “Obstetrics & Gynecology”. In volume 135 – Issue 5 – p 1091-1094, researchers from Emory University School of Medicine, the Departments of Gynecology and Obstetrics and Ophthalmology, Emory University School of Medicine, and Midtown Urology, Atlanta, Georgia published an article titled, “Pentosan Polysulfate-Associated Macular Disease in Patients With Interstitial Cystitis.” Below are their findings:
- Recent studies have implicated long-term pentosan polysulfate (Elmiron) use with vision loss from a newly described macular condition. Affected patients report difficulty with reading and adjusting to dim lighting, and they occasionally develop severe visual disability. Macular changes resemble those seen in age-related macular degeneration, potentially leading to misdiagnosis. The objectives of this Current Commentary are to summarize studies evaluating the association between Elmiron use and macular disease, to educate Elmiron prescribers about the clinical manifestations of this condition, and to provide recommendations for screening at-risk patients. Studies demonstrate an association between long-term Elmiron use and a newly identified vision-threatening macular condition.
What is the Elmiron lawsuit all about? Maculopathy.
The Elmiron lawsuits claim that long-term exposure to Elmiron can cause maculopathy and other eye problems.
Maculopathy is a generalized term that refers to pathological conditions that affect the central part of the retina, the macula. Maculopathy is characterized by a progressive loss of central vision, usually bilateral, that greatly impairs vision functions. This is where visual acuity and sensitivity occur. There are certain types of maculopathy:
- Age-related Macular Degeneration – This is an age-related condition that occurs over time.
- Cellophan Maculopathy – known as a “macular pucker” this condition causes a transparent layer of scar tissue to pull on the light-receptive nerves of the macula.
- Malattia Leventinese – known as “Doyne Honeycomb Retinal Dystrophy” (DHRD) and is prompted by small, pale spots that grow on the macula, eventually creating a honeycomb pattern.
Pigmentary macular degeneration associated with Elmiron is an injury with no known cause. Each person presents the signs and symptoms differently.
Some other Elmiron side effects include:
- Alopecia (hair loss)
- Rectal Hemmorage
- Liver Function Abnormality
- Blood in the stool
- Gastroesophageal reflux
- Skin rash
- Sleep disorders
What do doctors recommend if you are experiencing a potential eye side effect? According to the INTERSTITIAL CYSTITIS NETWORK, “they urge patients who have used or are using Elmiron to be screened by ophthalmologists if they are experiencing any unusual eye symptoms (difficulty reading, vision loss, difficulty seeing in lower lights) and to cease Elmiron therapy if eye disease is present.”
- IC Network – First Lawsuit Filed Over Elmiron Eye Damage – Pelczar v. Teva Branded Pharmaceuticals R&D et al
Tips if you suspect Elmiron has caused eye problems. Talk with Doctor.
- First off, Don’t Panic! Print a copy of the articles hyperlinked throughout this page. They are also included at the bottom under “References”. Take them to your Urologist and Eye doctor.
- Seek An Eye Examination – If you have taken Elmiron and feel that you have some eye issues, we believe that you should seek a full eye examination.
- Talk With Your Doctor About Alternatives To Elmiron – The Emory Eye Center researchers encourage the cessation of Elmiron if eye disease is noted. Other bladder coating therapies are available, such as Heparin/Lidocaine instillations as well as over-the-counter supplements CystoProtek, Cysto Renew and/or Desert Harvest Aloe. Please discuss the pros and cons with your urologist.
- Spread The Word – I encourage you to share this article with people you know that take Elmiron. Share it on Facebook, Twitter or other online communities and message boards.
Free Downloadable Guide – Give This to Your Doctor
Does Elmiron cause weight gain? Yes. According to the Package Insert of Prescribing Information, Elmiron’s manufacturer states, “Weight gain and swelling caused by fluid build up in the body have been reported in patients taking ELMIRON®.”
Is there an Elmiron Safety Warning? None of the products labeling describes symptoms or side effects related to pigmentary maculopathy, or any other kind of eye damage, issues, or problems. It only references vision disorders such as conjunctivitis, optic neuritis, retinal hemorrhage. Yet, pigmentary maculopathy has been reported by a number of people after taking Elmiron. So if you have developed maculopathy after taking Elmiron, you may qualify for the Elmiron lawsuit.
Elmiron Lawsuits Filed Against Janssen Pharmaceutical For Elmiron Associated Retinal Maculopathy
The lawsuit alleges that the manufacturer of Elmiron failed to warn patients and their doctors about the substantial eye side effects associated with the drug.
The complaint further states, “According to the Drugs@FDA website, the label for Elmiron has been updated on approximately five occasions, at no time has it contained any information about vision loss, including pigmentary maculopathy, in any section of the label. The only mention in the label of any visual adverse events is a disclosure in the Adverse Reactions section that reveals clinical trial patients reported conjunctivitis, optic neuritis, amblyopia, and retinal hemorrhage. However, none of these adverse events are related to pigmentary maculopathy.”
Elmiron Class Action Lawsuit (Now Filed)
We have not identified a class action filing on Elmiron.
The class action lawsuit alleges Janssen Pharmaceutical’s drug Elmiron (pentosyn polysulfate) is associated with vision loss and seeks class certification and a medical monitoring fund.
Furthermore, in this action they seek class certification to establish a fund to be used for medical monitoring of patients using Elmiron to monitor the status of their vision. The case, Allen v. Janssen Pharamceuticals, Inc. et al. was filed in the United States District Court for the Eastern District of Pennsylvania on May 6, 2020.
Class action lawsuits are often misunderstood by the general public. A class action suit is generally filed against the manufacturer of a product or service provider when the attorneys are seeing a refund on a faulty product or fraudulent/misrepresented service. Or in the case of this class action filed on Elmiron, they are seeing to establish a fund for patients who need to continually have their eyes checked. When a product causes individual harm or personal injury, like Elmiron, lawyers will typically file individual cases (not class actions).
This can be confusing but the point being, Johnson // Becker is (i) filing individual lawsuits on behalf of patients who were injured by Elmiron and (ii) they have also filed a class action suit against the manufacturer.
Do You Have an Elmiron Lawsuit? Contact a Lawyer Today.
Have you had any of the above side effects after taking Elmiron? Have you been diagnosed with pigmentary maculopathy or do you suspect that Elmiron has caused eye damage or some other sort of eye problems? If so, you should contact a lawyer who is handling Elmiron lawsuits. You may be entitled to financial compensation for your injuries.