A North Carolina woman has alleged in a recently filed lawsuit that long-term use of Elmiron caused a form of retinal damage known as pigmentary maculopathy.
The lawsuit alleges that Johnson & Johnson, Janssen Pharmaceuticals, Ortho-McNeil Pharmaceuticals and Teva Pharmaceuticals withheld information about Elmiron’s risks from users and the medical community.
The woman was diagnosed with interstitial cystitis in 1998 or 1999 and was prescribed Elmiron, which she used until 2020. The woman started having problems with her vision in April 2019, including loss of central vision, trouble adapting to darkness and night vision problems. The woman was eventually diagnosed with pigmentary maculopathy.
Elmiron is an interstitial cystitis drug. The Emory Eye Center in Atlanta, GA discovered Elmiron’s link with pigmentary maculopathy, publishing its findings in May 2018. The authors of the finding suggest retinal cells might be accumulating Elmiron over time. Elmiron’s United States label, however, was not updated until June to warn about pigmentary maculopathy.
“Due to the absence of any warning by Defendants of the risks posed by Elmiron, Plaintiff was unaware that use of Elmiron could result in retina damage and vision impairment,” the lawsuit claims. “This danger was also unknown to Plaintiff’s healthcare providers or the general public due to Defendants’ failure to warn.”
The lawsuit seeks to recover damages based on numerous claims for relief, including fraudulent concealment, negligence – failure to warn, strict liability – defective design, breach of express warranty and violation of the North Carolina Unfair & Deceptive Trade Practices Act. The lawsuit seeks compensatory, exemplary, statutory, treble and/or punitive damages.
The lawsuit notes that the defendants took steps to warn people outside of the U.S. about Elmiron’s risk of pigmentary maculopathy. Elmiron’s Canadian label was revised in September 2019 to warn of the risk, and defendants “agreed” with a European Medicine Agency recommendation that Elmiron’s label warn about pigmentary maculopathy in 2019.
A second Emory Eye Center study, in 2019, found that Elmiron causes structural changes to the retina and that it is unclear whether stopping Elmiron can alter the course of the disease.
Researchers said in 2019 that Kaiser Permanente data showed that 24% of Elmiron users had the same pigmentary maculopathy symptoms described by the Emory study.
Harvard researchers have also confirmed the link between Elmiron and pigmentary maculopathy. Harvard treated a patient whose eye disease was still worsening six years after stopping Elmiron.