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Vision Problems from Elmiron May Continue To Progress After Treatment: Study

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The findings of a new study indicate Elmiron vision loss problems not only leave former users of the interstitial cystitis drug with persist retina damage, but the injury could continue to progress even after use of the medication stops.

Researchers with the Emory School of Medicine published a study this month in the medical journal JAMA Ophthalmology, which found that some users diagnosed with Elmiron-induced maculopathy experience vision problems that continue to worsen even 10 years after halting use of the drug.

Elmiron (pentosan polysulfate sodium or PPS) has been sold by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary in the United States since 1996, and has been promoted as a safe and effective treatment for interstitial cystitis or “painful bladder syndrome”, which is a chronic condition with no known cure, resulting in most users staying on the treatment for years, or even decades.

Over the past year, a series of studies and case reports have been published by independent researchers linking Elmiron side effects to pigmentary maculopathy, which may cause permanent vision loss, blurry vision, dark spots and prolonged adaption to dim light.

In this latest study, researchers looked at 11 patients, all female, from ages 53 to 63 years old, who were diagnosed with Elmiron-associated maculopathy and looked to see what happened after at least six months of drug cessation and up to 10 years.

According to the findings, the women showed no demonstrable improvement in their conditions after discontinuing Elmiron. In addition, 9 of the 11 patients, or 82% saw their vision continue to worsen.

“These retrospective data among 11 patients suggest PPS-associated maculopathy countinues to evolve after drug cessation for at least 10 years,” the researchers warned. “In some cases, progressive retinal pigment epithelium atrophy encroaches on the foveal center and thus may pose a long-term threat to central vision.”

The findings echo those published in a case study late last year, which described a 69-year old woman whose eyes have continued to deteriorate six years after ending use of the medication.

Although concerns existed for years among vision specialists about the risk of retina damage, Elmiron vision warnings were not added to the drug label in the U.S. until last month.

The label update came after a series of independent studies and case reports published in recent years highlighted cases involving visual injury and pigmentary changes in the retina among long-term users of Elmiron. The drug has been linked to reports in which users to experienced difficulty adjusting in dark light, problems reading, centralized dark spots and other complications, yet information about the risk of pigmentary maculpathy was withheld from the drug warning label for years.

As a result of the failure to warn consumers for decades, the drug makers now face a growing number of Elmiron lawsuits being pursued by former users left with permanent, and potentially worsening vision problems.

Since most ophthalmologists were previously unaware about the potential vision side effects of Elmiron, many users are just now learning that long-term exposure to the drug may be the cause of eye problems they have been suffering for years.

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