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A growing number of product liability lawsuits are being filed nationwide over Elmiron vision loss problems, as more long-term users of the interstitial cystitis drug discover the medication may have left them with retinal damage, which they previously had no idea was a possible side effects.
In a complaint (PDF) filed on September 8, Emily Ann Scheibe and her husband, Harry, say it is likely tens of thousands of patients nationwide face a risk of vision problems due to long-term use of Elmiron, and a prior failure to provide adequate warnings for users and the medical community.
Elmiron (pentosan polysulfate sodium or PPS) has been marketed as safe and effective since 1996, without any indication the drug may cause latent retinal damage or impaired vision until the drug makers until a warning label in June 2020
The new warnings now advise users, urologists and opthalmologists that Elmiron side effects have been linked to a form of eye disease known as pigmentary maculopathy, which can cause a range of vision problems, including difficulty adjusting in dark light, trouble reading, centralized dark spots and other complications.
According to allegations raised in the lawsuit filed by Schiebe and other plaintiffs, the drug makers knew or should have known about the risk for years, as a series of independent studies and case reports have been submitted, involving long-term users of Elmiron who experienced vision problems.
Schiebe, of Georgia, began taking Elmiron on advice from her doctor for the treatment of interstitial cystitis, which causes severe bladder pain. The lawsuit claims that, as a result of Elmiron use, she developed PPS-associated pigmentary maculopathy, which has permanently damaged her vision.
According to the lawsuit, neither she nor her doctor received adequate warning of the risk of vision damage, because Janssen ignored reports of adverse events from patients and health care providers.
“Throughout the time Defendant marketed Elmiron, Defendant withheld material adverse events from the public, medical community and FDA,” Scheibe’s lawsuit states. “Defendant failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy. Ultimately, tens of thousands of patients, including Plaintiff, were placed at risk and harmed as a result of this misleading conduct.”
Since most ophthalmologists were previously unaware of the vision risks associated with Elmiron, many users were misdiagnosed with other forms of retinal disease and continued to be exposed to the medication, further worsening the damage.
As Elmiron lawyers continue to review and file claims in the coming months and years, it is expected that hundreds of similar complaints may be brought in state and federal courts nationwide.