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A recently filed product liability lawsuit indicates that thousands of interstitial cystitis patients may have been left with permanent maculopathy and vision loss from Elmiron, since the drug makers did not provide warnings for users and the medical community about toxic side effects the medication may have on the retina..
In a complaint (PDF) filed in the U.S. District Court for the Eastern District of Pennsylvania on September 30, Joyce A. Hoppe indicates Janssen Pharmaceuticals withheld information about maculopathy problems experienced by long-term users from the public, medical community and federal regulators.
Elmiron (pentosan polysulfate sodium or PPS) was introduced as a “niche” treatment in 1996, without any warnings or indication the drug may cause latent retinal damage or impaired vision. It was only after a series of independent case reports and studies were published in recent years about the link between Elmiron and maculopathy that the drug maker announced a warning label update 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 the lawsuit, Hoppe, of Wisconsin, was diagnosed with interstitial cystitis in 2003, and prescribed Elmiron by her doctor. She took the drug until October 2018. In early 2018 she began to experience vision problems which have progressively worsened. In 2019, she was diagnosed with maculopathy, which resulted in latent, retinal damage and impaired vision.
“Defendants knew, or should have known, of the significant risks for visual symptoms and retinal changes associated with the use of Elmiron when taken as prescribed and intended,” the lawsuit states. “Despite knowing about these significant risks, Defendant did not disclose these significant risks to the medical and healthcare community, including Plaintiff’s prescribing doctor and the Food and Drug Administration until June 2020.”
The case joins a growing number of Elmiron lawsuits now being pursued throughout the U.S. court system, each involving similar allegations that former users may have avoided permanent retinal damage if earlier warnings and information had been provided.
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.