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According to allegations raised in a recently filed product liability lawsuit, Johnson & Johnson’s Janssen Pharmaceuticals subsidiary has marketed Elmiron as a safe and effective treatment for interstitial cystitis, yet the drug not only fails to provide bladder pain relief, but may leave users with permanent vision problems.
The complaint (PDF) was filed by Jane Gruppo in the U.S. District Court for the Southern District of Ohio on September 21, indicating that long-term use of the medication left her with a form of retinal damage known as maculopathy, and did very little to treat her underlying interstitial cystitis (IC) diagnosis.
Gruppo began taking Elmiron about 15 to 20 years ago, according to the lawsuit. After about a decade of use, she began experiencing vision problems, which were diagnosed as maculopathy in 2015. However, doctors were unaware of the link between Elmiron and her vision problems since the drug makers failed to disclose the risk. As a result, she had to undergo genetic testing in 2017 and continued taking the medication for years.
It was not until March 2020, after medical studies began warning of serious eye problems linked to Elmiron use, that her doctors were able to diagnose Gruppo with bilateral neovascular acute macular degeneration, active chorodial neovascularization, stable pattern dystrophy, stable lattice degeneration and dry eye syndrome. Her doctors linked these problems directly to the side effects of Elmiron, and she discontinued her prescription that same year.
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 until the drug makers updated the Elmiron 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 the lawsuit, Janssen’s own efficacy clinical trials showed Elmiron to be ineffective at treating interstitial cystitis. In phase IV of the trials, there was no statistical difference in relief of symptoms between patients who took Elmiron, and those who took a placebo.
“In short, Defendant’s own Phase IV efficacy study establishes that Elmiron does not work,” Gruppo’s lawsuit states. “It did not provide improvement in symptoms of IC or bladder pain syndrome and in fact was less beneficial than Placebo for patients with IC.”
The lawsuit indicates Janssen has been aware for decades that Elmiron does not work, and still decided to sell a drug with no proven benefit, which exposes patients to unnecessary drug side effects, like PPS-associated pigmentary maculopathy; a condition specific to Elmiron use.
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 vision loss 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.