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More Evidence About the Risk of Maculopathy With Use of Elmiron

Consideration was given for the editing and publication of this post.

Elmiron (Pentosan Polysulfate Sodium) is a drug used to treat discomfort due to a certain bladder disorder called Interstitial Cystitis. However, a report was released last 2018, claiming that Elmiron possibly causes retinal damage to patients who took the medication.

The report claims that Elmiron usage is associated with the risk of acquiring maculopathy. Maculopathy, also known as Macular Retinopathy, is a pathological condition that affects the Macula, the central part of the retina responsible for producing keen vision. This report prompted consumers to file a lawsuit against Janssen Pharmaceuticals.

The Result Behind The Study Conducted

Ophthalmologists conducted a review regarding the claims against the drug Elmiron. They examined patients from Kaiser Permanente located in Northern California and discovered that one-fourth of the exposed patients show signs of eye damage.

These symptomatic patients have significant exposure to Elmiron over the past years or even decades of usage. The toxicity of the said drug can also possibly disguise as age-related macular degeneration. This is why most patients who acquired the disease due to the medication mistakenly thought it was just due to aging.

Interstitial Cystitis affected over 1 million Americans, mostly women. The FDA approved only one pill for the said disease, which was Elmiron. Millions of people in the U.S. consumed Elmiron for decades without knowing its negative effect on their vision.

In 2018, Dr. Nieraj Jain, M.D., from Emory Eye Center in Atlanta, Georgia, revealed that six of his patients who are taking Elmiron manifested unusual changes in their Macula. Dr. Jain and his colleagues warned the public about the damage caused by the long-term use of Elmiron, as the patient doesn’t have any medical history that can cause abnormalities.

Ophthalmologists at Kaiser Permanente, led by Dr. Robin Vora, M.D., Dr. Amar Patel, M.D., and Ronald Melles M.D., took the warning and monitored all their patients. At first, they found a woman undergoing a long-term treatment with Elmiron that was misdiagnosed with a Retinal Dystrophy.

Over 4.3 Million patients in Kaiser’s database were examined due to the Elmiron issue. Out of these patients, 140 was found to have taken an average of 5,000 pills of Elmiron for 15 years. Ninety-one of these said patients agreed to undergo an examination, which revealed that 22 out of the 91 patients showed signs of drug toxicity due to Elmiron.

They have also discovered that the toxicity rate increases along with the amount of drug consumption. Patients who take 500 to 1,000 grams of Elmiron have an 11% chance of acquiring drug toxicity, while patients who took 1,500 grams or more have a 42% chance.

Symptoms of Elmiron-Induced Maculopathy

Patients who have been taking Elmiron for an extended period have been reported to have pigment changes in the retina referred to as Pigmentary Maculopathy. Although the cause of this pigmentation is uncertain, continued medication with Elmiron might be one of the risk factors.

The Kaiser study revealed that most patients showing symptoms are caucasian women with an average age of 60. These patients manifest the most common symptoms of Elmiron-induced Maculopathy, such as blurred and dimming of vision, difficulty reading and seeing close objects, metamorphopsia, paracentral scotoma, and slow adjustments to light and darkness.

During the examination, specialists recorded different signs of Elmiron-induced eye disease, such as:

      Parafoveal Pigment Deposits, which are abnormal blood vessels forming around the Macula

      Vitelliform Deposits, which are round, yellowish deposits below the central retina or Macula

      Hyperpigmentation around the Macula

      Retinal atrophy

The exposure of these patients to Elmiron imposed safety concerns because patients might have lost their vision due to these diseases. Even patients without genetic or age-related conditions might still be at risk if exposed to Elmiron.

What to Do If You Are Injured Due to Elmiron Usage

Elmiron plaintiffs in the US have filed lawsuits as they thought the pharmaceutical company was already aware of the side effects of the drug even before the study revealed it. If you are one of the consumers in the US who used Elmiron, you can hire a lawyer to assist you in filing a case.

You can qualify to file a lawsuit if you take Elmiron for at least two years up to the present and currently suffer from visual problems. Your visual problems should commence after you started using Elmiron or after you stopped taking Elmiron medication. For instance, you stopped taking Elmiron in 2016 and were diagnosed with visual problems in 2017. You are still qualified to file a lawsuit.

If you qualify to file one, do not hesitate to contact an Elmiron vision loss lawyer. Hiring a lawyer who specializes in this field can give you 100% assistance and educate you along the way. These lawyers have experience in handling similar cases that will benefit you in the long run.


This information provided can help you understand whether you are suffering the symptoms of maculopathy due to Elmiron medication. It can also help you understand your rights in filing a lawsuit. There are already lawsuits filed by qualified patients who are now suffering from visual impairment due to Elmiron.

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