Published on January 7, 2021
In recent years, new studies and claims have emerged regarding the urinary drug pentosan polysulfate sodium, known by its commercial name Elmiron, that have linked long-term usage of the drug to a degenerative eye disorder called pigmentary maculopathy, which may lead to vision loss or blindness. As a result, there have been a number of class action and single lawsuits against manufacturers of the drug, filed by those who have suffered eye damage due to using this popular medication. Seeing these reports is certainly cause for alarm if you or a loved one have been a long-term user of this medication, but be aware that usage does not guarantee that you will suffer from pigmentary maculopathy, and even if you do, that there is no certainty that you will go blind as a result. Regardless, suffering any type of injury due to using pentosan polysulfate sodium is unacceptable, and you have every legal right to pursue compensation from the manufacturer of this dangerous medication for distributing something that can cause such serious, permanent harm.
Contact Balkin & Mausner Today For a Case Evaluation Regarding Elmiron Eye Damage
If you or a loved one has suffered eye injuries due to long-term usage of pentosan polysulfate sodium, more commonly known as Elmiron, then contact us as soon as possible for a free initial consultation and case evaluation with our experienced and aggressive attorneys who are ready to take your case today. Knowing where to turn after realizing the damage that this medication has caused is overwhelming, but we are confident that once you speak to our attorneys, you will be able to focus on your personal issues and needs without being bogged down by the additional worry about your legal outlook.
The sooner we receive the details of your particular case, the sooner you can start looking towards the future with confidence. The consultation is free, so even if you are uncertain of your situation, we will be happy to help. Read more below about Elmiron and pigmentary maculopathy, and contact us as soon as possible to get started on your legal journey today.
What Is Elmiron?
Pentosan polysulfate sodium, otherwise known by the commercial name Elmiron, is an oral medication prescribed to patients who suffer from a painful bladder syndrome known as interstitial cystitis and is the only medication approved by the Food and Drug Administration for treating this issue. The medicine is highly effective and acts by helping to restore the mucus layer around the bladder, known as the glycosaminoglycans layer. Since 1986, this medication has helped people suffering from interstitial cystitis and other bladder and pelvic pain, but recent findings have connected the long-term use of this medication with a number of eye issues, including blindness.
Elmiron is manufactured and distributed by Janssen Pharmaceuticals and has been widely used since its initial approval by the FDA in 1996. Recently, the FDA has implemented an update to the safety labeling of Elmiron to include additional warnings and precautions for usage. The new subsection states:
Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.
Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON®. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.
For many, these warnings may be too little, too late. If you are one of the many people who have used Elmiron long-term (typically 3 years or more before damage begins to show), then contact Balkin and Mausner as soon as possible so we can fight for the compensation you deserve after exposure to this dangerous medication.
What Eye Problems Does Elmiron Cause?
You will hear that the main issue caused by long-term exposure to Elmiron is “pigmentary maculopathy,” but this term covers a number of specific effects that you may identify as problems that you have suffered from. Maculopathy is a general term for damage to the macula, which is the area of the eye responsible for fine vision such as reading and focusing on small items. Pigmentary maculopathy is a unique form of maculopathy caused by Elmiron, and some of the most common effects that sufferers report include:
- Difficulty reading
- Pain in the eyes
- Partial or complete blindness
- Difficulty seeing in low light situations
- Difficulty seeing things that are up close
- Distorted vision or disturbances to eyesight
These effects are not meant to be taken as fully inclusive of the injuries that Elmiron users may suffer, so if you have had any eyesight issues and have been taking Elmiron for longer than 3 years, speak with your doctor immediately to start working on an alternative for treating your interstitial cystitis, and contact Balkin & Mausner Injury Lawyers, LLP so we can begin building your legal case.
What To Do If Your Eyesight Has Suffered Due To Prolonged Elmiron Usage
If you or a loved one has used Elmiron long-term and are now suffering adverse effects relating to your eyes, it is important that you begin exploring your legal options as soon as possible. While no amount of money can undo the damage from exposure to this medication, it can certainly help to mitigate the financial impact that blindness or eye damage can cause to you and your family. It will take your attorney time to build your case, and ultimately determine whether you will be filing an individual lawsuit against Janssen Pharmaceuticals or if it makes more sense to join an ongoing class-action lawsuit. There are costs and benefits to either of these decisions, and you will need to work with your lawyer in order to determine which option makes the most sense for your situation, given your circumstances and the extent of the injuries that you have suffered.
See Your Doctor
The first thing that you should do is contact your doctor to come up with a plan for how you will treat your interstitial cystitis while either discontinuing or adjusting your use of Elmiron given the injuries that it has caused. At the same time, your doctor will be able to refer you to an ophthalmologist who can help you understand the extent of the damage caused by Elmiron, as well as develop a treatment plan for you in order to maximize your health outcomes given the unfortunate situation. Working with specialists is a proven way to ensure that you are getting comprehensive care and support throughout this difficult process.
Why Choose Balkin & Mausner Injury Lawyers, LLP?
Once you have addressed your health issues, you can then start to consider your legal options. Balkin & Mausner offers a free initial consultation and case evaluation. Once we know the details of your eye injury, we can begin building a case and fighting to get the compensation that you deserve after suffering eye injuries from Elmiron usage. Just as it is important to work with medical professionals as soon as possible to address the damage your eyes have suffered, it is equally important to begin working with an attorney as soon as possible so that they have time to build your case and identify all of the possible avenues forward.
There are statutes of limitation that you will need to stay mindful of, and while they often feel like there is plenty of time before the statute expires, this time is important for building a case and negotiating possible out-of-court settlements. Before you know it, you will be racing the clock if you do not take the first step as soon as you are able to. Balkin & Mausner Injury Lawyers, LLP will begin working on your case from the moment that we meet with you for your initial consultation. Call today!