Elmiron-Associated Maculopathy: Symptoms and Diagnoses

With the rise of Elmiron lawsuits, one important question is, what should the official diagnosis be in order to meet the lawsuit criteria?

Long-term Elmiron (pentosan polysulfate sodium) use is linked with a vision-threatening condition called maculopathy.

Video source: Does Elmiron cause Pentosan Polysulfate Maculopathy?

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What Are Some Common Symptoms of Elmiron-Associated Maculopathy?

There are a number of common symptoms to PPS-associated maculopathy:

• A patient taking Elmiron could have blurred vision.
• They could have difficulty reading, difficulty adjusting to dim lighting: coming out of a bright room going into a dark room, or coming out of a house going into the street at night.
• They could have problems with dark adaptation.
• They could also be suffering from problems with glare or blind spots.
• All of a sudden, maybe the colors are not as vivid as they used to be.
• Some people report night blindness.
• Some people report something called metamorphopsia, which is a type of distorted vision which presents itself in your eyes as a grid of straight lines that sometimes appear wavy. And parts of the grid might actually be blank. People might first notice that they suffer from this condition when they’re looking at mini-blinds in their home.

And then blindness (loss of vision). The underlying injury that is caused to the eye by Elmiron is an injury to the retina.

What Are Some of the Maculopathy Misdiagnoses That May Happen?

A lot of our clients are misdiagnosed with various diagnoses such as age-related macular degeneration, or AMD for short.

While both forms of macular degeneration involve damages to the retina and cause loss in the center field of vision, the injury is much more than AMD.

The area of the retina that is damaged from Elmiron is different. And I would say that the injury caused by Elmiron can be described as a “fingerprint”-type injury that has a very unique presentation when a retinal specialist performs retinal imaging.

It just stands out because they had never seen this injury before the discovery of Elmiron.

Some other misdiagnoses are:

• Macular dystrophy
• Pattern dystrophy
• Maculopathy general, you know, which is just a general damage to the retina
• Macular disease
• Retinopathy
• Stargardt’s disease, severe loss of retinal pigment epithelium with photoreceptor loss, sometimes referred to as RPE

What Would a Target Diagnosis Be?

The diagnosis that we are looking for in our clients after they get the retinal imaging that is required is pigmentary maculopathy, or changes to the pigmentary layer of the retina. Or pentosan Elmiron toxicity. Another one would be pentosan polysulfate sodium Elmiron toxicity, or just drug toxicity.

How Can Elmiron-Associated Maculopathy Be Diagnosed?

It is most often diagnosed using three different retinal imaging techniques. The first one is the fundus autofluorescence imaging, or FAF. Now, I would describe that as more like actually a picture. It was like a photograph of your retina. And when you’re looking at this photograph, if someone has Elmiron-related toxicity of their retina, it’s pretty obvious in an FAF imaging.

The other imaging that retinal specialists use is the optical coherence tomography, also known as OCT. And it’s a different technology that shows a different presentation and shows some unique findings only related to Elmiron toxicity.

Near-infrared fundus reflectance, also known as an NIR, is also another kind of imaging tool that has very unique findings when you’re dealing with Elmiron toxicity.

All three of these imaging tools are painless. They are relatively quick. Retinal specialists generally will have them in their office. And what we’re finding is sometimes when one of them is positive, they end up doing all three. Each one gives you a little bit different look or perspective on the damage caused by Elmiron.

Elmiron-Associated Maculopathy FAQ