Delayed-Onset Retinal Damage From Elmiron Discovered; Elmiron Lawsuit Filed
A November case report describes a case of delayed-onset retinal damage from the use of Elmiron (pentosan polysulfate).
The case report states that a 44-year-old woman who was exposed to a cumulative amount of 435g of Elmiron presented 38 months after last taking Elmiron with metamorphopsia which had been worsening for six months as well as prolonged dark adaptation. An examination found characteristic features of pentosan polysulfate maculopathy, a form of retinal damage which has been found to be caused by Elmiron.
“This case suggests that new onset clinically detectable pentosan polysulfate maculopathy may develop years after drug cessation,” the study’s abstract concluded.
Lawsuit Claims Elmiron Caused Woman To Go Legally Blind
A lawsuit filed on November 24 in federal court in Pennsylvania claims that Elmiron use caused a Texas woman to go legally blind.
The lawsuit states the woman was prescribed Elmiron for interstitial cystitis in or about August 1997, and that the woman took Elmiron from 1997 to 2020. The woman started experiencing progressive visual issues, such as blurred vision and difficulty adapting to the dark, in or about 1999, according to the lawsuit.
The woman was diagnosed with maculopathy with pigment changes in the macular region of both eyes in 2002, and was diagnosed with macular degeneration of the retina in 2010, when she was declared legally blind, according to the lawsuit.
The lawsuit states the woman was diagnosed with chorioretinal degeneration caused by Elmiron toxicity in October 2020.
Lawsuit Alleges Janssen Knew About Retinal Damage, Failed To Warn Or Recall
The lawsuit accuses Janssen Pharmaceuticals of knowing that Elmiron was causing vision damage in users, yet failing to warn about it or recall the drug.
The lawsuit notes that a 2018 study reported on several long-time Elmiron users who presented with significant vision loss, yet Elmiron’s U.S. label was not updated to reflect the risk of vision loss until June 2020.
“Defendant’s U.S. label change came too late to benefit Plaintiff and thousands of other Elmiron users,” the lawsuit states.
The lawsuit also notes that Janssen changed Elmiron’s label in September 2019 to reflect the risk of visual symptoms.
The lawsuit claims that Janssen ignored reports of injuries associated with long-term Elmiron use, and instead of doing adequate testing to determine the injuries’ cause or rule out Elmiron as the cause of the injuries, continued to market Elmiron as safe. The lawsuit claims the plaintiff would not have taken the drug had Janssen warned her about the risks of taking the drug.