Elmiron Side Effects May Include Maculopathy

After being on the market for almost 25 years, the painful bladder syndrome drug known as Elmiron has recently come under fire for its connection to retinal damage. Until now, Elmiron side effects have been considered mild. However, new studies show a concerning link between the drug and a serious eye disease known as retinal maculopathy.

A red -haired woman in her late thirties receives an eye exam as she leans towards a phoropter. Elmiron's side effects may now include retinal maculopathy.

 

Since there are an estimated 8,000,000 women who deal with Interstitial Cystitis (IC) and Elmiron is still the only prescription drug available to treat its symptoms (Interstitial Cystitis Association), thousands may be at risk for serious eye damage.

What does this mean for countless Americans, especially women?

If you or someone you know has used Elmiron, whether recently or in years past, the following information may be critical for your health. Whether you used it for a few months or years on end, all patients are encouraged to see a trained ophthalmologist and begin assessing their vision health immediately.

Read on to learn about frequently asked questions regarding Elmiron’s side effects, retinal toxicity, and what you can do if you believe you’ve been injured. You may qualify to join women all over the U.S. in the lawsuit against Elmiron’s makers.

 

Research Suggests Long-Term Elmiron Side Effects

When it comes to pharmaceuticals, drug manufacturers have a responsibility to properly warn the public of all known side effects related to their product. This includes taking the time to look further into potentially serious reactions observed in early clinical trials.

Did Elmiron’s makers know about its relation to retinal damage? It appears they did. A four-year clinical trial in the late 1990s included a list of potential side effects, among them, optic neuritis and retinal hemorrhage.

It’s troubling to note that instead of looking into these symptoms, Janssen Pharmaceuticals concluded they weren’t important enough to justify additional study.

Even while Janssen Pharmaceuticals stopped short of researching Elmiron’s side effects, studies continued in the medical community.

A woman receives a retinal scan by an ophthalmologist to check for retinal mauclopathy due to Elmiron.

 

Emory Eye Center’s Study – Atlanta, GA

In 2015, Emory Eye Center — a research-based clinical eye care facility in Atlanta — launched an analysis of six female patients who were all diagnosed with the same eye disease. Interestingly, none of the women had a family history of eye disease or preexisting factors to explain their condition, yet all of them had retinal maculopathy.

A deeper investigation revealed a startling commonality: all six women were Elmiron patients. One of the subjects had begun noticing her vision problems when she was just 30 years old.

Emory released their findings in 2018, triggering a wave of more independent studies by ophthalmologists around the country. Elmiron’s side effects were now being reconsidered in light of this pioneer report.

 

Kaiser’s Study — Oakland, CA

Alerted by Emory’s study, doctors at a Kaiser hospital in Oakland searched their database for patients with Elmiron prescriptions. Of 140 patients using the IC drug, 91 consented to be tested for retinal maculopathy.

Kaiser’s study showed that 25% of those tested had retinal maculopathy.

Yet, these startling results did nothing to prompt Janssen Pharmaceuticals to issue a voluntary recall, nor did they halt Elmiron sales. Janssen Pharmaceuticals took no action in response to the data showing potential Elmiron side effects.

 

IC Network Survey — 2019

Perhaps the most startling news came when Jill Osborne, founder and president of the Interstitial Cystitis Network, invited readers to fill out a survey in December 2019. Her goal was to gauge how many of them were experiencing Elmiron side effects, particularly eye problems.

54% of those surveyed said they had eye damage and used Elmiron.

The full extent of the impact is not yet known, but it is estimated that hundreds of thousands of Americans who used Elmiron may have been exposed to potentially damaging side effects.

Without the right education and a fair warning, neither doctors nor patients are able to appropriately consent to take Elmiron. Had Janssen Pharmaceuticals fulfilled its duty to inform the public about the potential risk for retinal maculopathy, a myriad of people might not be suffering from it.

Both doctors and patients are still learning about the deepening connection between Elmiron and eye disease.

A closeup shot of a fair-skinned woman's eye, which is light green. Many women who took Elmiron are at risk for developing retinal maculopathy.

 

Retinal Damage Not Listed Under Elmiron Side Effects

As concern grows over Elmiron’s link to eye disease, it’s important to consider its other known adverse effects. Janssen Pharmaceuticals lists the following as common Elmiron side effects:

  • Hair loss
  • Bruising
  • Headache
  • Abnormal liver function tests
  • Dizziness
  • Diarrhea
  • Swelling due to fluid buildup
  • Nausea
  • Weight gain
  • Blood in stools
  • Rash

These conditions are mild overall, with few requiring urgent medical attention. Moreover, a relatively low percentage of patients experience them, according to an FDA clinical trial:

  • Alopecia (4%)
  • Diarrhea (4%)
  • Nausea (4%)
  • Headache (3%)
  • Rash (3%)
  • Dyspepsia (2%)
  • Abdominal pain (2%)
  • Liver function abnormalities (1%)
  • Dizziness (1%)

Neither eye damage, nor retinal toxicity or retinal maculopathy are currently listed as side effects. Yet, research indicates that the number of Elmiron patients dealing with eye problems is much higher than that of those experiencing all other side effects combined. To compound the seriousness of the situation, these eye conditions are also permanent, whereas the current side effects are mostly treatable.

“Research indicates that the number of Elmiron patients dealing with eye problems is much higher than that of those experiencing all other side effects combined.”

Unfortunately, women who have been diagnosed with retinal damage are discovering the news through their doctors, when both doctors and patients have a right to be warned about these potential side effects from the manufacturer itself — Janssen Pharmaceuticals.

A woman is shown with her back to the camera, speaking to a doctor blurred out of focus. Women who use Elmiron are finding out about the risk of retinal maculopathy from their doctors, rather than Janssen Pharmaceuticals.

Drugmakers are obligated by law to inform patients and doctors of any potential side effects associated with their products at the earliest known time. As a consumer, you have a right to decide for yourself if the side effects are worth the benefit of taking any prescription drug. This is called informed consent.

For example, when patients are required to sign a formal document that lists a drug’s known side effects, they are agreeing to the risks that come with using that drug. By doing this, the patient is acknowledging that he or she has been formally notified of any adverse reactions before being given a prescription.

Janssen Pharmaceuticals simply did not do this.

Doctors are still learning about what causes retinal maculopathy and how it relates to another condition called retinal toxicity. Below is a summary of the difference between the two.

 

Retinal Toxicity vs. Retinal Maculopathy

When toxins build up in the retina, it is known as retinal toxicity. Symptoms include trouble reading, loss of color vividness, and a blurred center spot in vision often known as bull’s eye maculopathy.

A photo of a flower stand simulates bull's eye maculopathy due to retinal toxicity, where the center of the image is blurred. This is just one of the symptoms of retinal maculopathy.

Retinal toxicity is what doctors believe may be causing retinal maculopathy. They speculate that Elmiron patients may be suffering from a build-up of the drug with continued use:

“The authors suggest that the retinal cells may be accumulating PPS (pentosan polysulfate sodium or Elmiron) or a toxic metabolite over time.” IC Network

 

Retinal Maculopathy Symptoms

When a disease is a new discovery, doctors term it as “novel.” Retinal maculopathy is such a disease, and researchers are still trying to understand what causes it.

Elmiron users who have been diagnosed with retinal maculopathy share the following symptoms:

  • Image distortion
  • Trouble adjusting to dark environments
  • Seeing “spots” in the center of eyesight
  • Trouble reading
  • Blurred vision
  • Color dullness

 

Elmiron Patients May Be Misdiagnosed

As more and more Elmiron patients are screening their vision, it’s difficult to say just how many of them have retinal maculopathy. There are three main reasons for this:

 

1. Age-related macular degeneration (AMD), pattern dystrophy (PD), and retinal maculopathy have similar symptoms.

 

A senior man is given an eye exam by a young female optometrist.

Age-related Macular Degeneration (AMD) describes the loss of central vision caused by retinal damage. Risk factors include smoking, high blood pressure, obesity, family history, and age (American Academy of Opthalmology). Those 50 and above are most at risk for AMD.

Pattern dystrophy (PD) is an umbrella term to describe retinal diseases caused by waste buildup in the macula. PD is genetic, yet has many of the same symptoms as AMD and develops more slowly (Macular Society).

Even though AMD, PD, and retinal maculopathy have markedly similar symptoms, each stems from unique causes and will thus need to be treated differently.

 

2. Retinal maculopathy requires a diagnosis from an ophthalmologist.

If you think you may have retinal maculopathy, keep in mind that a regular visit to the optometrist won’t reveal it. You will need to be seen by an ophthalmologist, who will conduct a test with advanced retinal imaging.

The fear here is that many Elmiron patients are being misdiagnosed with AMD and PD without realizing they may actually have retinal maculopathy. Since the symptoms between these conditions are strikingly similar, only a screening by an ophthalmologist will confirm whether or not retinal maculopathy is present.

If you’ve used Elmiron and have had eye problems, doctors are advising patients to see an ophthalmologist as soon as possible to be tested for retinal maculopathy.

 

H3: Eye damage may continue after stopping Elmiron use.

The Elmiron community was rocked when in the fall of 2019, a Harvard University doctor named Rachel Huckfeldt released a study on a female patient. The results revealed that her eye damage continued to worsen even long after she stopped taking Elmiron.

More than ten years after she stopped taking Elmiron, her vision became worse.

Harvard scientist and doctor Rachel Huckfeldt.

Harvard scientist and doctor Rachel Huckfeldt. (Image: Harvard.edu)

Huckfeldt began seeing the patient in 2001 when the woman noticed blurriness and trouble adjusting to darker environments. She was concerned to see the woman had no family history or other reason for the symptoms, concluding that a toxic substance must be at play in the unexplained eye disease.

Dr. Huckfeldt described the woman’s condition as “toxic retinopathy.”

Years later in May 2018, Huckfeldt learned of Emory’s study on the six female patients with a mysterious eye disease. She immediately checked her patient’s medical history and confirmed she had used Elmiron in the past but had stopped taking it in 2003. The woman’s vision continued to worsen even ten years after discontinuing her Elmiron use.

 

Elmiron Lawsuit FAQs

Elmiron lawsuits are growing by the day as more people begin to learn of its dangers, especially women. Whether you or a loved one is thinking about seeking legal help, you likely have questions. We’ve provided a few answers below to guide you in your research.

If you don’t find the answers you’re looking for here, our dangerous drug attorneys are available to help you understand whether you qualify for an Elmiron lawsuit, free of charge. Please contact our offices at (800) 388-3905 for a private, complimentary review of your potential case.

A woman at her laptop jots down notes as she is on the phone while researching Elmiron lawyers.

 

How much does it cost to join the Elmiron lawsuit?

There are no out of pocket fees for joining the lawsuit against Janssen Pharmaceuticals for injuries related to Elmiron. Simply start by contacting the dangerous drug lawyers at Searcy Denney for a free consultation, where we will review the details surrounding your unique experience with Elmiron and help you determine whether a lawsuit is right for you. This is free, private, and without obligation.

If you choose to hire our firm, we will represent you on a contingency fee basis, which means we do not collect any legal fees unless your case is successfully settled or taken to verdict. Our fees are deducted from your total recovery amount.

 

Are all law firms accepting Elmiron cases the same?

Not all law firms are equally qualified to handle your Elmiron case. When choosing the right firm to represent you, there are a few factors you should take into consideration.

First, check to see if the law firm can prove they are experienced in pharmaceutical litigation. Not only will you want to know how many years of experience they have handling these types of cases, but you’ll want to take a look at a list of their verdicts and settlements. These are results from past cases.

Searcy Denney has been holding negligent billion-dollar drug companies accountable for over 40 years and has won $5 billion for injured Americans. Our formidable track record and success rate against large corporations upholds our upstanding reputation in the legal community.

Secondly, ask your lawyers if they have the financial backing to see your case through. Large medical corporations like Janssen Pharmaceuticals have endless resources at their disposal, including strong legal teams to defend their bottom line. You will want to choose a firm that is prepared to match the defense in terms of resources.

With more than 28 lawyers and extensive staff, Searcy Denney is fully equipped to take on even the toughest defense teams in litigation. We have an established network of field experts, investigators, and industry professionals as well as the monetary means to go to all necessary lengths for building your case.

Lastly, verify that your lawyer has trial experience. The fact is, the vast majority of cases will not be heard before a jury. However, when a drug company is particularly unwilling to settle, the case may go to trial. In the event that it does, you will want to be sure the law firm you choose has prior experience.

As our case results indicate, Searcy Denney has brought numerous cases to verdict and carries one of the most established reputations in the legal community for their courtroom experience. We are unafraid and ready to fight for your just compensation at every level, including during trial.

 

Do I qualify for an Elmiron lawsuit?

If you took Elmiron and have suffered any type of vision problem, you likely qualify to join the lawsuit against Janssen Pharmaceuticals. To be sure, however, each person’s case will need to be evaluated individually.

To find out if you qualify, simply contact us by filling out this short form or calling our offices at (800) 388-3905.

Important: Time is limited to join the lawsuit, so call us today!

 

Talk to Our Elmiron Lawyers Today

 

The personal injury attorneys at Searcy Denney are now accepting cases for Elmiron side effects, including retinal maculopathy.

Whether you have vision problems or not after taking Elmiron for any period of time, you might still be at risk for developing retinal maculopathy. All patients should be advised of the IC drug’s connection with eye disease and see an ophthalmologist as soon as possible.

The dangerous drug attorneys at Searcy Denney are here to help you make the best choice for you and your family. Please call us today to see if you qualify to join the Elmiron lawsuit.

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