Patients have been prescribed the drug Elmiron since 1996 to treat a condition called interstitial cystitis (IC), also commonly known as painful bladder syndrome. Throughout this time, it has come to light the drug has some very severe side effects for Elmiron users that the manufacturer, Janssen Pharmaceuticals, failed to warn the public. The side effects all connect to a condition called pigmentary maculopathy, a serious eye condition that can result in blindness. To date, millions of people worldwide have been taking Elmiron to manage their bladder pain with no idea they could be compromising their vision.
At this time, it is unknown how many people have or will be affected. If you or a loved one have been taking Elmiron, you may be entitled to seek financial compensation for your injury and suffering. At the Jacob Fuchsberg Law Firm, our dangerous drugs attorneys are here for you. You don’t have to suffer alone, not knowing if you or your loved one will suffer this drug’s extreme side effects. We’ll make sure your rights are protected and will support you with all of our legal resources.
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Elmiron is an oral drug approved by the U.S. Food and Drug Administration (FDA) in 1996. Elmiron is the medication’s brand name and is manufactured and distributed by Janssen Pharmaceuticals, one of many companies owned by Johnson & Johnson. The drug’s scientific name is pentosan polysulfate sodium (PPS). While it has other medical uses, it is primarily used for IC, which is both chronic and painful.
IC can afflict both men and women, but women are most commonly diagnosed and treated with Elmiron. It is estimated three to eight million women (roughly 3% to 6%) in the United States may have IC. The drug is classified as a urinary analgesic and weak anticoagulant, which means it’s meant to be used as a pain reliever or a (weak) blood thinner. This drug, when prescribed, is most often used for the long-term for people experiencing acute and persistent bladder pain.
While Elmiron has been on the market for almost 25 years and used for the long-term by many patients, it is emerging there is a common link between patients who use Elmiron and severe eye problems. IC is the condition most Elmiron is most commonly prescribed for, but it also is occasionally prescribed for osteoarthritis and as an anticoagulant. There is no generic equivalent for this prescription drug, and there is no cure for IC. Essentially, the only FDA approved drug for IC is Elmiron. If patients want relief from IC symptoms, doctors can only prescribe them to take Elmiron.
Like most prescribed drugs, Elmiron does have side effects that are listed on its labels. Common side effects associated with Elmiron use include nausea, diarrhea, upset stomach, blood in the stool, hair loss, headache, dizziness, gastroesophageal reflux, abnormal liver functions, bruising, swelling, sleep disruptions, and weight gain.
What’s not listed in the drug’s side effects for patients in the United States are problems associated with eye disorders and vision impairment. Patients in Europe and Canada already had this warning, but U.S. consumers were not warned until recently. It wasn’t until June 2020 Janssen added the risk of vision loss to its Elmiron labels produced for U.S. consumers which state “cumulative dose appears to be a risk factor” when referring to maculopathy (an eye disease affecting the retina and macula).
Symptoms medical professionals and researchers are linking to the use of Elmiron include vision loss, maculopathy, and drug toxicity. Elmiron used for the long-term has been linked to permanent loss of vision. Sadly, to date, hundreds of thousands of people have routinely taken this drug and these patients are at risk for permanent vision damage or loss.
Some have reached beyond the “risk” stage. Unfortunately, an alarmingly large number of patients have struggled with serious vision problems and retinal injury from consistent and long-term use of PPS. Furthermore, ophthalmologic studies are finding patients who have taken Elmiron are experiencing a never seen eye condition. Through advanced retinal imaging, medical experts are seeing the pigment cells within the eye’s retina change color, and a patient’s symptoms are similar to the effects seen in the condition traditionally described as macular degeneration. Due to the unique traits, this form of eye disease is displaying; experts are classifying the condition as pigmentary maculopathy to distinguish it from other forms of maculopathy.
In 2019, the American Academy of Ophthalmology (AAO) shared a study originating from Kaiser Permanente in Northern California that linked the drug Elmiron to a specific type of maculopathy, called pigmentary maculopathy. These patients had no apparent cause to develop pigmentary maculopathy, but one common denominator was they had all used Elmiron. According to their statistics, almost 25% of people using Elmiron suffered retinal damage.
This study corroborates an earlier study by Emory Eye Center in Atlanta from 2015-18 that came to similar conclusions. Since this time, numerous other studies by ophthalmologists have emerged in 2020, which also link Elmiron to maculopathy and related vision problems. Several additional reports and studies examining this serious injury are still pending publication, but are expected to confirm similar findings that link PPS and maculopathy.
Maculopathy, also commonly known as macular degeneration, is a serious eye condition. This eye disease is one of the primary causes of blindness in the United States and the Western world. It is a retinal disease that affects the central part of the eye’s retina, known as the macula. People suffering from retinal maculopathy typically have a gradual loss of central vision. Other symptoms include:
A serious problem is many patients may not initially realize their eyes are being affected when using this drug since symptoms aren’t always easy to detect early on in maculopathy. Adverse events may be gradual or misinterpreted for another form of maculopathy, such as age-related macular degeneration.
PPS is prescribed by medical professionals to treat patients for IC to relieve their chronic and painful bladder symptoms. Symptoms for IC bladder condition may vary for each patient, but typically they are:
Doctors often prescribe PPS to relieve the symptoms associated with bladder pain syndrome that primarily occur in women aged 30 or older. Sadly, many of these women who are already suffering from a painful and uncomfortable medical condition were not alerted to the fact their eyes were at risk for retinal disease and permanent vision loss.
Are you taking or have taken Elmiron and are experiencing problems with your eyes? Suppose you are having difficulty doing everyday activities, such as reading, driving, seeing colors properly, or having problems adjusting in dim lighting or merely seeing things differently. In that case, you may be suffering the adverse Elmiron side effects. If you are currently taking PPS for IC or another condition, talk to your healthcare provider immediately to discuss your continued use of this drug.
Attorneys in the United States are currently filing Elmiron lawsuits. Suppose you or someone in your family was prescribed Elmiron for IC or another condition and took it for at least two years and are showing symptoms associated with maculopathy. In that case, you may qualify to file for an Elmiron vision loss and blindness lawsuit. You’ll want to contact an Elmiron vision loss attorney as soon as possible so you can protect yourself and ensure the statute of limitations for personal injury doesn’t expire. If eligible for a lawsuit, you can receive financial compensation for medical treatments, medical bills, pain and suffering, lost wages and earning capabilities, and other damages you’ve endured due to your vision problems stemming from Elmiron use.
Many patients have filed individual lawsuits against Janssen Pharmaceuticals and Johnson & Johnson. A few recent cases filed against the makers of Elmiron include the following.
These cases and numerous other lawsuits cite the failure of both Janssen Pharmaceuticals and Johnson & Johnson to warn consumers about the severe risks to their eyes and vision associated with taking Elmiron. It is also alleged early clinical trials uncovered a link between Elmiron and eye disease. Still, the company chose to simply ignore these findings and neglected to list this side effect on warning labels. At this point, it is anticipated numerous Elmiron cases will be filed.
If you are an Elmiron patient, even if you aren’t currently showing symptoms, you should contact an Elmiron vision loss and blindness attorney as soon as possible for legal advice. Sadly, some patients are developing symptoms long after discontinuing the use of the drug. The Jacob Fuchsberg Law Firm will evaluate your case for free and determine if you are eligible to participate in an individual or class-action lawsuit. Our dangerous drugs attorneys are here to support you and your family.
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