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Janssen Pharmaceuticals faces a product liability lawsuit that accuses the company of releasing a dangerously defective bladder drug, without warning users they may develop pigmentary maculopathy from Elmiron, resulting in permanent retina damage.
The complaint (PDF) was filed by Johneen S. Spice in the U.S. District Court for the Eastern District of Pennsylvania on July 8, indicating that side effects of Elmiron caused her to suffer vision loss and other complications.
Elmiron (pentosan polysulfate sodium or PPS) is the only approved drug treatment for interstitial cystitis or “painful bladder syndrome”, and has been marketed as safe and effective since 1996. 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.
Spice, of Indiana, began taking Elmiron in 2011 for the treatment of interstitial cystitis and bladder pain. However, in 2017 she began suffering vision problems and was diagnosed with permanent retinal injury and vision loss. Her lawsuit blames Elmiron for her injuries, saying it is a “dangerously defective prescription drug.”
“Defendant designed, marketed, and distributed Elmiron in the United States, all the while knowing significant risks that were never disclosed to the medical and healthcare community, including Plaintiff’s prescribing doctor, Food and Drug Administration, to Plaintiff, and/or the public in general,” the lawsuit states. “Further, Defendant failed to provide adequate warnings to patients and the medical community, including Plaintiff’s prescribing physician, of the risks associated with using the drug.”
The complaint comes as a growing number of Elmiron pigmentary maculopathy lawsuits are now being filed throughout the federal court system. Since most ophthalmologists were previously unaware that side effects of the bladder drug may impact the eyes, many Elmiron users indicate they were previously misdiagnosed with other retinal diseases, such as macular degeneration, pattern dystrophy and other problems.