Thousands of Elmiron users have filed lawsuits alleging that exposure to the drug has caused damage to the retina, affecting their vision.

Elmiron is a brand name for an anticoagulant drug that is classified as a low molecular weight heparin. The drug was approved by the Food and Drug Administration in 1996 for the treatment of interstitial cystitis, or IC. This is a condition affecting the bladder that results in chronic pain and impacts urinary frequency.

Elmiron is the only approved oral pharmacological treatment for IC, but concerns have arisen about its side effects.

A 2018 report published by the Emory Eye Center indicated that long-term exposure might be toxic to the eye and damage the sensitive retinal tissue. Subsequently, another report presented at the American Academy of Ophthalmology meeting in October 2019 also offered more evidence suggesting the bladder medication could result in a “vision-threatening” eye condition.

The 2019 evidence suggests as many as a quarter of patients who had “significant exposure” to the drug had developed signs of eye damage. Specifically, patients on Elmiron face a substantially increased risk of pigmentary maculopathy, retinal maculopathy or macular degeneration.

In January 2020, the first lawsuit against Janssen Pharmaceuticals was filed by affected individuals. The plaintiffs allege both that Elmiron caused unexpected damage to the eye resulting in vision impairment and that Janssen Pharmaceuticals may have been aware of the risk and withheld adverse event reports from the public and from the Food and Drug Administration.

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