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What Is Pigmentary Maculopathy?

Sharon Brandwein
October 14, 2020

While most maculopathies are either congenital or age-related, pigmentary maculopathy is the direct result of prolonged exposure to pentosan polysulfate sodium, the active ingredient in the drug Elmiron.

What Is Maculopathy?

Maculopathy is a broad term that refers to any chronic condition of the macula, the area of the eye associated with visual acuity and sensitivity. There are several types of maculopathy Including:

Age-related macular degeneration

Macular degeneration is an age-related, degenerative condition that results in gradual vision loss.

Cellophane maculopathy

Cellophane maculopathy is a condition where one’s vision is distorted as a result of the formation of scar tissue on the macula.

Doyne Honeycomb Retinal Dystrophy (DHRD)

DHRD is a congenital form of macular degeneration that starts with small, pale spots on the macula that eventually develop into a honeycomb pattern.

What Is Pigmentary Maculopathy?

As we mentioned above Pigmentary Maculopathy is a severe side effect caused by taking the medication Elmiron (active ingredient pentosan polysulfate sodium)  which is used to treat interstitial cystitis, more commonly known as painful bladder syndrome.

Although the symptoms of pigmentary maculopathy vary from person to person, common symptoms include:

  • Parafoveal pigmented deposits - abnormalities in the capillaries and blood vessels around the macula, eventually resulting in vision loss.
  • Vitelliform deposits - yellowish lesions that form under the macula.
  • Retinal pigment epithelium atrophy - a dying off of retinal epithelial cells that result in a loss of vision - a common symptom of macular degeneration.

elmiron eye damage

Treatments For Pigmentary Maculopathy

Maculopathies are progressive degenerations, and while they don’t cause complete blindness, they can cause a loss of central vision, which accounts for about 3% of one’s visual field. A loss of central vision affects our ability to discern shapes, estimate distances, or even distinguish details of faces when talking to others.

Generally speaking, there is no known cure for maculopathy, and the damage is irreversible, but doctors will frequently monitor the disease’s progression closely with regular eye exams. That said, lifestyle changes like increased physical activity, smoking cessation, and sticking to a healthy diet can slow the progression of the pigmentary maculopathy.

The Case Against Elmiron

Elmiron was approved for the treatment of interstitial cystitis or painful bladder syndrome in September 1996; however, concerns over its potentially toxic side effects have only recently surfaced.

2018 saw the first study linking Elmiron to pigmentary maculopathy. This initial study conducted by the Emory Eye Care center linked six patients who developed pigmentary maculopathy with their exposure to pentosan polysulfate sodium — the active ingredient in Elmiron.

Since this initial study, numerous studies have since followed, all of which have corroborated the original findings.

Of all the lawsuits swirling around the makers of Elmiron, the one that seems to stand out is the case involving Valerie Hull. Hull — otherwise known as patient zero in the first study linking Elmiron to pigmentary maculopathy, filed a lawsuit in New Jersey Superior Court on June 9, 2020.

According to the press release, Hull claims that the makers of Elmirom (including Johson & Johnson, Janssen Pharmaceuticals, and Teva Pharmaceutical Industries Ltd.) knew about the potential risks associated with the drug for decades and failed to warn patients and doctors about the risks and potential loss of vision as a side effect. Moreover, product labeling includes no relevant warnings, nor does it include any language warning of pigmentary maculopathy as a risk.

What Should You Do If You Have Taken Elmiron?

If you or a loved have or are currently taking Elmiron, it is strongly suggested that you get your eyes checked by an ophthalmologist. If you believe you have suffered vision damage or eye problems, then you may be entitled to compensation and join the fight against Janssen Pharmaceuticals for failure to warn about the risks of vision loss and eye damage that are clearly associated with Elmiron usage.

If You Or A Loved One Have Been Harmed By Elmiron You May Be Entitled To Compensation


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We are here to help you and loved ones advocate for justice. Feel free to send us any questions you might have, either about an injury or the process for pursuing justice so we can help you exercise your rights.

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