Elmiron Eye Disease Lawsuits

Experts warn more than half of Elmiron patients may be at risk of serious eye disease.

Elmiron (pentosan polysulfate sodium) is a mild blood-thinner prescribed to treat bladder pain caused by interstitial cystitis, or bladder inflammation.

elmiron eye disease lawsuit

Elmiron Eye Disease Risks

Elmiron is approved for 300 mg doses in those 16 or older, but is often prescribed for up to 1,500 mg per day for severe symptoms of IC. 

The FDA approved Elmiron in 1996, and it has been prescribed to millions of people since as the only oral medication to treat bladder pain or discomfort associated with IC. 

Unfortunately, recent studies show patients taking Elmiron may have a higher risk of developing a rare but serious eye disease called retinal maculopathy. Similar to macular degeneration, this condition alters pigment cells in the retina, causing significant eye dysfunction and vision loss. 

And, doctors warn that most people who’ve suffered retinal maculopathy may have been misdiagnosed with macular degeneration, meaning they don’t even know the drug was the cause.

Unfortunately, however, the company gave no prior warnings about the cancer risks, putting thousands of patients at risk. Therefore, anyone affected may be entitled to substantial compensation.

Do You Qualify for a Lawsuit?

If you’ve taken Elmiron in the past, the first and most important step is to speak with your doctor. This way you can determine if you’ve suffered an eye disease, document the severity of damage, or, if your eyes are still healthy, establish a baseline for future comparison. 

Even if your eye doctor previously diagnosed you with age-related macular degeneration, it’s important to inform them that you’ve taken Elmiron so they can update your diagnosis based on the new findings. 

Next, it’s important to speak with a lawyer about your rights as soon as possible, since there is a time limit to filing a claim. While most eye diseases surfaced soon after Elmiron use, many patients suffered damage years after they last took the drug. 

Lawyers are investigating lawsuits for any patient that took Elmiron and later suffered vision loss or was diagnosed with an eye disease.  

Some of the most common symptoms of eye disease from Elmiron include:

  • Blurred vision
  • Difficulty reading
  • Colors appear dull or less vivid
  • Difficulty seeing in dim lighting
  • Dark spots in center of vision
  • Straight lines appearing curved.

DrugNews can connect you directly with a lawyer today, without the hassle of speaking to a call center, intake person or paralegal. And, it costs nothing to investigate or file a claim unless you win. Contact us today.

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Elmiron Warnings Timeline

Elmiron Lawsuits Details

Interstitial cystitis advocacy group IC Network conducts study of 1,604 members taking Elmiron, finding 53.87% report having developed retinal disease. The group notifies the FDA and petitions regulators to add warnings to Elmiron’s label.
Dr. Rachel M. Huckfeldt publishes Harvard case report in the Journal Ophthalmic Surgery Lasers and Imaging Retina of a female eye patient that had treated for 8 years for progressive retina damage and worsening vision. The condition was linked to Elmiron although the patient had stopped taking the drug 6 years earlier.
Doctors at Kaiser Oakland present study of 91 patients to the American Academy of Ophthalmology, finding 24% of Elmiron users had the exact retinal maculopathy and pigmentary damage that was present in the original Emory patients.
Emory Case Study is published in the Journal of Ophthalmology. However, due to the small amount of patient data, more research is necessary to determine effects of dosage, duration of use, percentage of patients affected and permanency of damage.
Emory Eye Center concludes a case study of 6 patients that took Elmiron, finding a new eye disease termed "retinal maculopathy" that is similar to macular degeneration and is caused by the pigment cells in the retina changing color.
FDA approves 100mg dose of Elmiron as an oral capsule form of pentosan polysulfate sodium to treat interstitial cystitis. Despite some clinical trial evidence of eye damage, no warnings are added to the label.

Did Janssen Ignore Elmiron Eye Risks?

Before publishing their study in The Journal of Ophthalmology, doctors at the Emory Eye Center reviewed early clinical trials of Elmiron performed by the manufacturer, Janssen Pharmaceutica.

They found that in an unmasked clinical trial of nearly 2,500 patients taking Elmiron, researchers noted both vision loss and eye related side effects. 

Specifically, the clinical trials informed Janssen that certain patients developed optic neuritis and retinal hemorrhage while taking Elmiron.  

Although Janssen had this information for more than 20 years, the company never added any warnings to Elmiron’s label, or conducted any further research to explore if there was a way to explain how Elmiron could cause such serious eye disorders. 

Instead, they ignored the risks, continuing to earn billions of dollars selling Elmiron. Now, they face thousands of lawsuits from patients that suffered severe eye disease. If you are among those affected, contact us today for more information about filing a claim. 

Dangerous Elmiron Side Effects

The maker of Elmiron, Janssen Pharmaceutica, lists several common side effects for the drug, including:

  • Hair loss
  • Diarrhea
  • Nausea or dizziness
  • Headache
  • Stomach or abdominal pain
  • Depression
  • Skin rash or itching.

However, recent studies have linked Elmiron with more serious side effects, a unique progressive eye disease called retinal maculopathy. 

This condition can cause changes to the retinal pigment cells, leading to permanent and degenerative eye function and vision loss. 

Doctors have compared retinal maculopathy to retinal pigmentary endothelium injury (RPE), or age-related macular degeneration. In fact, it is often misdiagnosed as one of these other conditions in patients that have taken Elmiron. 

Some of the most common symptoms of retinal maculopathyinclude:

  • Blurred vision
  • Difficulty reading
  • Colors appear dull or less vivid
  • Difficulty seeing in dim lighting
  • Dark spots in center of vision
  • Straight lines appearing curved.

If you or a family member have experienced any of these vision related side effects after taking Elmiron, it is important to speak with your doctor as soon as possible.

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Choosing the Right Elmiron Lawyer

If you or a loved one have suffered eye disease or vision loss after taking the IC drug Elmiron, it’s important to find out if your medication was a factor.  

Our qualified Elmiron lawyers will fully investigate your case, reviewing your medical records, pharmacy records and recent studies that your doctor may not normally discuss. However, there’s only a limited amount of time to file a claim. 

DrugNews works only with attorneys and law firms that have successfully handled thousands of pharmaceutical injury lawsuits against the largest companies. And, we make it easy to speak directly with a lawyer or patient advocate to learn all about your legal options. 

You won’t pay anything unless you receive an award. Our qualified lawyers can handle most aspects of your case without you ever having to leave your home or attend court hearings.  

For more information, or to learn about your options - call, chat or email us today.

Do you have a case?

Speak with a lawyer who specializes in the Elmiron litigation.

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