Elmiron, manufactured by Janssen Pharmaceuticals, was approved by the U.S. Food and Drug Administration (FDA) in 1996. Elmiron is a drug prescribed to treat Interstitial Cystitis (IC), which is a condition of the urinary tract system that causes abdominal and pelvic pain. This condition is sometimes referred to as “painful bladder syndrome.” Elmiron is currently the only FDA-approved drug for the treatment of IC. Elmiron has been prescribed to millions of people worldwide since it was placed on the market.

Researchers and scientists have determined that the long-term use of Elmiron (pentosan polysulfate sodium) may cause a degenerative eye disorder, Pigmentary Maculopathy, which in turn may result in partial vision loss or even total blindness. Janssen Pharmaceuticals was alerted to the association between Elmiron and vision loss or eye damage but it did not warn doctors or customers for many years. This caused countless patients to be exposed to risks of eye damage and vision loss.

Research data shows that up to 25% of long-term Elmiron users may have developed ocular damage which can lead to vision loss and blindness. Because optometrists and ophthalmologists were unaware of the link between eye damage and Elmiron, some patients may have initially been misdiagnosed with another vision disorder such as macular degeneration or pattern dystrophy. However, a closer examination of these patient profiles and records is now revealing that their vision problems may very well have been caused by Elmiron usage.

People who took Elmiron for longer than six months and who developed eye problems and vision loss, may be eligible for compensation in an Elmiron vision loss lawsuit. If you or someone you know has sustained eye damage or vision loss and previously used Elmiron, let the Elmiron eye injury attorneys at The Lackey Law Firm provide you with a free and confidential consultation. You can contact us at 256-259-3929. Our attorneys have years of experience representing victims of defective medical devices and pharmaceutical products such as Elmiron. Our law firm would welcome the opportunity to assess your situation and determine if you have a viable Elmiron claim against Janssen Pharmaceuticals.

What is Maculopathy?

Maculopathy (Retinal Pigmentary Maculopathy) describes several disorders to the central part of the retina, the macula. Retinal Maculopathy causes the pigment cells in the retina to change to a darker color. If problems in the macula are not addressed promptly, long-term vision impairment can occur. Even permanent vision loss can happen. The diagnosis of Pigmentary Retinal Maculopathy can be made by your ophthalmologist. If you are a long-term user of Elmiron, you should strongly consider undergoing an eye exam as soon as possible.

What are the Symptoms of Elmiron-Induced Retinal Maculopathy?

Long-term Elmiron users have reportedly experienced a series of vision-related symptoms, including but not limited to, the following:

  • Difficulty reading;
  • Difficulty adapting vision in low-light situations;
  • Permanent vision loss;
  • Vision irregularities;
  • Pain in the eye region;
  • Blindness;
  • Difficulty seeing close up;
  • Dark spots in the field of vision.

In 2018, studies began documenting visual problems in users of Elmiron and in 2019, scientific data presented at the American Academy of Ophthalmology showed that Elmiron use may be associated with an increased occurrence of macular damage which can lead to slow vision loss and ultimately, blindness.

Researchers who studied the problem, examined medical claims between 2002 and 2016 and found that up to one-quarter or 25% of patients taking long-term Elmiron may show signs of ocular toxicity and eye damage, indicating that thousands of people may have been harmed by the medication.

If you suffer from any of these eye conditions or problems and have used Elmiron on a long-term basis, please see a medical professional immediately. After seeking medical treatment, contact the Elmiron eye injury attorneys at The Lackey Law Firm for a free review.  We will be glad to meet with you at our offices in Huntsville, Alabama or Scottsboro, Alabama.

FDA Approves New Warning Label for Elmiron

In June of 2020, the FDA approved a warning label change submitted by Janssen Pharmaceuticals regarding the potential risks of developing retinal maculopathy and vision loss from usage of Elmiron. The new Elmiron warning label will be the first time that patients and eye doctors have been provided a written warning related to the risks of eye damage from using this drug. In December of 2020, Health Canada, which is similar to the FDA, revised the warning labels for eye doctors and patients in Canada. These warnings further state that Elmiron is now contraindicated in individuals who have a history of macular pathology and that any individuals on Elmiron should get routine eye exams.

Trust the Alabama Elmiron Eye Injury Attorneys at The Lackey Law Firm

The Elmiron eye injury lawyers at The Lackey Law Firm are pursuing Alabama Elmiron cases statewide on behalf of individuals who have suffered vision damage after taking Elmiron. If you or a loved one has questions about vision loss after using Elmiron, please contact us today for a free and confidential consultation. If we accept your case, we operate on a contingency fee basis, meaning we don’t get paid unless we recover money for you. Contact us at 256-259-3929.