Elmiron Maculopathy May Be Misdiagnosed as Other Vision or Eye Problems, Case Study Warns

As the medical community continues to learn about the risk of vision and eye problems from Elmiron, researchers warn about the importance of doctors carefully reviewing medical histories in a recent case report, which described a 41 year old woman misdiagnosed after developing atypical maculopathy from the interstitial cystitis drug.

The report was published late last year in the American Journal of Opthalmology Case Reports, involving a case of Elmiron maculopathy described by researchers with Kaiser Permanente, who were consulted for a second opinion by a woman misdiagnosed with a type of inherited macular degeneration known as Stargardt disease.

Elmiron (pentosan polysulfate sodium, or PPS) is a widely used Janssen Pharmaceuticals drug used for treatment of interstitial cystitis or painful bladder syndrome, which impacts more than 1 million people in the U.S., particularly women.

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Side effects of Elmiron have been linked to vision loss and retinal damage known as pigmentary maculopathy.

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Side effects of Elmiron have been linked to a serious vision problem known as pigmentary maculopathy, which causes deterioration in the retina and loss of vision over time, and is now increasingly referred to as PPS maculopathy, referring to the active pharmaceutical ingredient in the drug.

Although a number of case reports and independent studies have indicated that there may be a link between Elmiron and retina damage, the drug maker has not issued warnings in the United States and many urologists, ophthalmologists and other doctors remain unaware of the potential risk

In the recent case report, researchers describe a 41-year-old woman who sought a second opinion following a Stargardt disease diagnosis, which is a form of retina deterioration similar to PPS maculopathy, but is inherited and usually manifests in childhood.

The woman suffered side effects like darkening vision, progressive difficulty reading, and a loss of night vision. Her medical history included chronic interstitial cystitis, but she was misdiagnosed with Stargardt disease, until genetic testing turned out negative.

When the researchers reviewed her pharmacy records, they noted the use of Elmiron and realized she fit the toxicity profile, and diagnosed her as having maculopathy due to long term Elmiron exposure.

“This case highlights the importance of careful review of past medical histories and medication profiles of all patients, particularly those with retinal and imaging findings suggestive of a dystrophic process,” the researchers warned. “Failure to diagnose a medication toxicity in a timely fashion may lead to preventable irreversible vision loss.”

Researchers recommended the patient discontinue use of Elmiron, before she suffered additional vision loss.

The lack of knowledge among many in the medical community about the potential link between Elmiron and vision problems has resulted in many cases of misdiagnosed, and continued exposure to the drug.

As a result of the failure to properly warn users and doctors about the potential risk, Janssen Pharmaceuticals now faces a growing number of Elmiron lawsuits brought by former users who allege that they may have avoided permanent retina deterioration if information about the risk had been disclosed.

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