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Lawsuit: Manufacturer Should Have Changed Elmiron Label to Reflect Risks
Chaffin Luhana LLP
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An Illinois woman recently filed a new Elmiron class-action lawsuit in the U.S. District Court for the Eastern District of Pennsylvania. She claims that after taking Elmiron to treat her interstitial cystitis and bladder pain, she suffered from serious injuries. She seeks compensatory damages and a declaration that Elmiron is defective and unsafe for its intended use.

Studies Link Elmiron with Macular Disorder

The U.S. Food and Drug Administration (FDA) approved Elmiron (pentosan polysulfate sodium or PPS) in 1996 as a prescription drug for the treatment of interstitial cystitis (IC), a chronic bladder disease that can cause severe bladder pain, pelvic pain, and urinary frequency. To date, it is the only medication specifically approved for the treatment of this painful condition.

When the drug first came out, the label did not warn of any risks of eye problems. Yet several recent studies have indicated that long-term use of the drug can lead to vision loss. In a 2018 study, scientists revealed that chronic exposure to Elmiron was associated with an increased risk of an unusual form of maculopathy that the researchers named “pigmentary maculopathy.”

This condition is connected specifically to the use of Elmiron and involves the development of excess capillaries or pigmented spots over the retina that affect central vision. The researchers recommended additional investigation.

In a follow-up study, scientists examined data from 219 patients with IC, 80 of which had prior exposure to Elmiron. Masked reviewers identified 14 cases of pigmentary maculopathy—all of them among those exposed to the drug. In a retrospective, matched cohort study, scientists found that patients exposed to Elmiron had a significantly increased risk of being diagnosed with a new macular disease at seven years.

“These findings bolster growing concern about a newly described medication toxicity and raise significant public health implications,” the researchers wrote.

According to her complaint, the plaintiff regularly took Elmiron from 2009 to the present. She says that as a result of her ingesting the drug for years, she is now at risk for severe visual injuries, including but not limited to loss of vision, retinal macular dystrophy, pigmentary maculopathy, and atypical macular degeneration.

Scientists Recommend Annual Check-Ups

The plaintiff seeks to achieve class-action status with this case. She wants to represent all individuals within the U.S. who were prescribed and took Elmiron who are currently asymptomatic for pigmentary maculopathy and have not received a diagnosis of retinal toxicity due to Elmiron use. She also wants to represent a similar class in the state of Illinois.

Class members should receive, according to the plaintiff, coverage for regular eye exams to monitor for signs of retinal damage. Indeed, scientists studying this condition have recommended testing both prior to prescription and for every year thereafter. Patients can be completely asymptomatic and still have signs of retinal toxicity, making check-ups particularly important.

The plaintiff claims the defendants are negligent as, despite the research, they have made no changes to the label or taken any steps to warn the medical community and users of the risks associated with taking the drug.

More troubling, manufacturer Janssen Pharmaceuticals changed Elmiron’s label in Canada in September 2019 to warn of the risks of pigmentary maculopathy. No such change has been made in the U.S.

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