Elmiron Linked to Maculopathy and Vision Loss in Patients

This popular prescription blood thinner, also known as pentosan polysulfate sodium, is commonly prescribed to individuals suffering from bladder pain and discomfort connected to interstitial cystitis.

For years, it was believed that Elmiron was safe for long-term use and that any side effects of this medication were mild. However, new research suggests that long-term use of Elmiron can lead to retinal damage, potentially leading to vision loss or blindness. 

This severe, life-altering side effect was not known to patients or disclosed to them before being prescribed Elmiron.

Numerous lawsuits have been filed since early 2022, with some of these being combined into a class-action multidistrict litigation (MDL) suit. These have been filed by patients whose eyesight has been damaged from prolonged use of Elmiron.

As these cases prepare to head to trial, potential plaintiffs who also used Elmiron and are now suffering vision troubles are encouraged to file compensation claims as well.

Interstitial Cystitis: Causes and Treatments

Interstitial cystitis is a painful condition in which the brain sends signals through the nerves, telling your bladder to urinate more frequently than normal.

Frequent urination can lead to pressure and discomfort in the bladder and pelvis, which is sometimes alleviated through urination. Those who suffer from IC may also experience pain when sitting for prolonged periods, as well as pain during sexual intercourse.

Doctors aren’t sure what causes IC, but several clear risk factors exist. For instance, you’re more likely to develop IC if:

• You’re a woman
• You’re in your thirties or older
• You have another chronic, painful syndrome, such as fibromyalgia or irritable bowel syndrome (IBS)

At present, there’s no known cure for IC. Treatment consists of drugs like Elmiron that are prescribed to help sufferers manage the pain and discomfort associated with this condition.

How Elmiron Works and Side Effects of Use

Patients with IC often suffer damage to the lining of their bladder wall. This damaged lining allows urine and other irritants to cause inflammation in the bladder wall.

Elmiron reduces inflammation, but not in the way that anti-inflammatory drugs like Tylenol or ibuprofen do. It’s believed that Elmiron works by creating a barrier along the bladder wall, protecting it against urine and other irritants.

By keeping irritants from coming into contact with the bladder wall, there are fewer potential causes of inflammation within the wall.

Some of the most commonly reported side effects of Elmiron include:

• Upset stomach 
• Bruising and rashes
• Hair loss
• Headaches and dizziness
• Bloody stool

These side effects will usually resolve on their own within a short time after commencing use of Elmiron. It’s worth speaking to your healthcare provider if these effects don’t go away or become disruptive to your daily life.

Maculopathy Risk and Elmiron Use

Maculopathy, also known as macular degeneration, refers to a progressive disease of the macula, an important structure within the eye.

When the macula is damaged, your vision will progressively get worse, as will your ability to see fine details. You may begin by noticing a “blind spot” in the center of your field of vision that gradually becomes larger and spreads to the periphery of your visual field. 

Once maculopathy is detected, treatment focuses on slowing the progression of the disease.

Currently, there’s no cure for maculopathy, which means that once a patient is diagnosed with macular degeneration, they’ll continue to suffer from the condition for the rest of their lives. There’s also no way to reverse vision damage caused by maculopathy.

There are various types of maculopathy, including age-related macular degeneration (AMD), which affects approximately 20 million people in the United States, according to the Bright Focus Foundation.

Another variety, pigmentary maculopathy, results in the appearance of spots on the retina that obstruct or interfere with vision. This type of maculopathy has been linked to the long-term use of Elmiron.

A 2018 study published in The Journal of Urology by Dr. William A. Pearce and others claimed that long-term use of Elmiron led to retinal damage.

This finding has been repeated in numerous subsequent studies, most recently a 2019 study by Dr. Rachel Huckfeldt and Dr. Demetrios Vavvas. In this study, researchers found that a patient’s maculopathy continued to worsen six years after they stopped taking pentosan polysulfate sodium.

These are just a few of the early studies that served to establish a connection between Elmiron use and pigmentary maculopathy. Further studies have continued to show that patients who use Elmiron over a prolonged period have a greater risk of vision loss due to pigmentary maculopathy.

Studies showing a link between Elmiron use and maculopathy associate long-term use of the drug with a greater risk of developing pigmentary maculopathy. 

Three or more years is typically the length of time considered to be long-term use, although there’s a non-negligible risk of developing maculopathy even with short-term use of the drug.

Elmiron Lawsuits and Claims

Janssen Pharmaceuticals, the manufacturer of Elmiron, didn’t warn patients that their use of Elmiron could jeopardize their vision.

Because drug manufacturers like Janssen Pharmaceuticals have a legal duty to inform patients of the potential risks associated with using their products, patients have filed lawsuits seeking damages from the company for their breach of this legal obligation.

A significant number of state and federal lawsuits against Janssen Pharmaceuticals have been filed in New Jersey, as that’s where Janssen’s is headquartered in the U.S. 

Hundreds of these cases were consolidated for trial, although injured patients who have developed pigmentary maculopathy can file and pursue their own lawsuits and aren’t required to join these class-action suits. The strength of these lawsuits rests in the scientific literature connecting pigmentary maculopathy with use of Elmiron.

Pigmentary maculopathy is known to be caused only by the use of pentosan polysulfate sodium. Although the symptoms of pigmentary maculopathy may appear similar to other forms of maculopathy, this specific diagnosis is connected exclusively with Elmiron use.

As such, those who have used Elmiron and developed pigmentary maculopathy have a strong claim against Janssen. However, it's impossible to guarantee a specific outcome until these cases are heard and decided in court or settlements are reached.

Elmiron Lawsuit Settlements and Trial Awards

No settlement has yet been reached in any Elmiron claim, though this doesn’t mean one is off the table entirely.

If a settlement is made, those whose pigmentary maculopathy has caused greater vision loss can expect far greater compensation than those whose pigmentary maculopathy is less advanced.

Similarly, patients whose cases proceed to trial can expect a higher award if their pigmentary maculopathy has resulted in near-total or total vision loss. Unfortunately, the greater the amount of vision loss, the more impact your condition will likely have on your quality of life, including your ability to work and enjoy various activities.

How to Tell if You Have Grounds for an Elmiron Lawsuit

If you have a legal claim against Janssen for compensation, it’s a good idea to file your lawsuit sooner rather than later. However, it can be confusing to know whether you qualify for compensation. An experienced attorney can help you evaluate your situation and advise you of your legal rights.

Generally speaking, if the following circumstances apply to you, there’s a good chance you have a claim.

You’ve Been Diagnosed and Treated for IC

First and most importantly, you’ll need to show that a qualified medical professional has diagnosed you with IC.

IC is a chronic condition for which there’s no known cure, so once you’ve been diagnosed by a competent healthcare provider, you shouldn’t need repeated diagnoses.

Your medical records should also establish a course of treatment for your symptoms that includes Elmiron. This shouldn’t be too difficult, as Elmiron is currently the only medication approved by the Food and Drug Administration (FDA) to treat the symptoms of IC.

Your Course of Treatment Included Being Prescribed Elmiron

While there are other methods whereby individuals with IC have attempted to manage the pain and discomfort associated with their condition, only Elmiron has been cleared by the FDA to treat the symptoms of IC, so it’s been a popular choice for doctors to prescribe to their patients.

In addition to showing that you’ve been prescribed Elmiron, your attorney will look for evidence showing the length of time you took the medication. Available records should also indicate that your use of Elmiron was consistent. Regular, long-term use of Elmiron has been linked to an increased risk of developing pigmentary maculopathy.

You’ve Developed Pigmentary Maculopathy After Taking Elmiron

Whether your eyesight has deteriorated gradually or quickly, a change in your vision likely drove you to an optometrist or ophthalmologist to have your vision examined. These professionals’ observations of your eyes, specifically your retinas, can lead them to diagnose you with pigmentary maculopathy.

It’s crucial for your eye care professional to have diagnosed you with pigmentary maculopathy and not some other form of maculopathy. Pigmentary maculopathy can be easily confused with other types of “wet” maculopathy, so named because vision loss occurs as the result of broken blood capillaries in the retina.

The reason it’s so important to show you’ve been diagnosed with pigmentary maculopathy is that the use of Elmiron is the only known cause of this disorder. Logically, if you have this condition, the only way you could have developed it is through taking Elmiron.

For this reason, you should ensure that your eye health professional knows you’ve taken Elmiron for your IC. This important information can change your eye doctor’s impression of the cause of your vision loss and prevent you from missing out on your chance to claim the compensation you need to deal with your condition.

Your Loss of Vision Has Impacted Your Quality of Life

Although it may seem obvious that losing your vision will negatively affect your ability to enjoy life to the fullest, successful plaintiffs will have witnesses and compelling documentary evidence available to demonstrate the true impact of their vision loss.

Your testimony, along with that of friends, family, and coworkers, can help paint a picture of the negative effects your visual difficulties have had on your life. For example, you may have been forced to quit your job or give up a hobby you’ve enjoyed for years.

You can complete the form on this page to schedule an evaluation of your claim, but even so, you should still follow up with an experienced product liability attorney.

Getting Legal Assistance with Your Elmiron Claim

You aren’t legally required to have an attorney’s help in pursuing compensation. Nonetheless, it’s highly recommended that you seek legal counsel in filing and pursuing your claim.

There are many benefits to this course of action. For example, your attorney can:

• Evaluate the legal merits of your claim
• Assist you in collecting evidence and interviewing witnesses
• File the paperwork necessary to start your lawsuit and move it along through the court system
• Help you decide whether to accept a settlement if one is offered
• Represent you and your interests in court and during negotiations

Without an attorney’s help, these and other tasks traditionally completed by an attorney would be entirely your responsibility. If your pigmentary maculopathy is advanced, you may find it difficult or even impossible to fulfill the duties necessary to successfully present your claim.

Patients with Pigmentary Maculopathy Have Legal Rights

Janssen Pharmaceuticals knew that its drug Elmiron could lead to the development of pigmentary maculopathy and vision loss in patients. Despite this knowledge, the company failed to take appropriate steps to warn patients of this risk so that they could discuss them with their doctors when deciding whether to start treatment.

If you believe you have a claim for compensation, don’t delay in taking action. While no amount of money can restore your vision, a settlement or award can help you cover medical costs and other expenses you’ve incurred as a result of your vision loss.